This review is published as a Cochrane Review in the Cochrane Database of Systematic Reviews 2008, Issue 4. Cochrane Reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and the Cochrane Database of Systematic Reviews should be consulted for the most recent version of the Review.</p

Cohen, Nicholas P.

McClinton, Samuel

N'Dow, James M. O.

Nabi, Ghulam

Rai, Bhavan Prasad

Shelley, Mike

English

Discovery Research Portal

                                                                    University of DundeeSurgical management for upper tract transitional cell carcinomaRai, Bhavan Prasad; Cohen, Nicholas P.; Shelley, Mike; N'Dow, James M. O.; McClinton,Samuel; Nabi, GhulamPublished in:Cochrane Database of Systematic ReviewsDOI:10.1002/14651858.CD007349Publication date:2008Document VersionPublisher's PDF, also known as Version of recordLink to publication in Discovery Research PortalCitation for published version (APA):Rai, B. P., Cohen, N. P., Shelley, M., N'Dow, J. M. O., McClinton, S., Nabi, G., & British Association of UrologicalSurgeons Section of Oncology (2008). Surgical management for upper tract transitional cell carcinoma.Cochrane Database of Systematic Reviews, (4), Article CD007349. https://doi.org/10.1002/14651858.CD007349General rightsCopyright and moral rights for the publications made accessible in Discovery Research Portal are retained by the authors and/or othercopyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated withthese rights.Take down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Download date: 12. Dec. 2025Surgical management for upper tract transitional cellcarcinoma (Protocol)Rai BP, Cohen NP, Shelley M, N’Dow JMO, McClinton S, Nabi G, British Association ofUrological Surgeons (BAUS), Section of OncologyThis is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The CochraneLibrary 2008, Issue 4http://www.thecochranelibrary.comSurgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.T A B L E O F C O N T E N T S1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iSurgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.[Intervention Protocol]Surgical management for upper tract transitional cellcarcinomaBhavan Prasad Rai2 , Nicholas P Cohen3, Mike Shelley4, James MO N’Dow5, Samuel McClinton6 , Ghulam Nabi1, British Associationof Urological Surgeons (BAUS), Section of Oncology71Academic Urology Unit, University of Aberdeen, Aberdeen, UK. 2Urology, ARI, Aberdeen, UK. 3urology, Aberdeen, UK. 4CochraneProstatic Diseases and Urological Cancers Unit, Research Dept, Velindre NHS Trust, Cardiff, UK. 5Ward 44, Aberdeen Royal Infirmary,NHS Trust, Aberdeen, UK. 6Department of Urology, Ward 44, Aberdeen Royal Infirmary, Aberdeen, UK. 7London, UKContact address: Ghulam Nabi, Academic Urology Unit, University of Aberdeen, 1st Floor Health Sciences Building, Foresterhill,Aberdeen, AB25 2ZD, UK. g.nabi@abdn.ac.uk.Editorial group: Cochrane Prostatic Diseases and Urologic Cancers Group.Publication status and date: New, published in Issue 4, 2008.Citation: Rai BP, Cohen NP, Shelley M, N’Dow JMO, McClinton S, Nabi G, British Association of Urological Surgeons (BAUS),Section of Oncology. Surgical management for upper tract transitional cell carcinoma. Cochrane Database of Systematic Reviews 2008,Issue 4. Art. No.: CD007349. DOI: 10.1002/14651858.CD007349.Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.A B S T R A C TThis is the protocol for a review and there is no abstract. The objectives are as follows:To determine the best surgical management of upper tract transitional cell carcinoma.The following comparisons are pre-stated:1.Whether open radical nephroureterectomy is better than laparoscopic nephroureterectomy2.Whether nephroureterectomy is better than conservative localised resection of ureter, where indicated3. Whether open surgical resection (local or nephroureterectomy) is better than endoscopic resection and surveillance, where indicated4.Whether open surgical method of handling lower end of ureter is better than endoscopic or laproscopic assisted methods1Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.B A C K G R O U N DUpper tract transitional cell carcinoma (TCC) arises from the re-nal pelvis, calices and ureters. These tumours are uncommon andconstitute only 5% of TCCs of the entire renal tract (Campbell-Wash 2003). TCCs of the renal pelvis account for 10% of all re-nal tumours and ureteric TCCs are even less common (El-Fet-touh 2002). Bilateral disease is extremely rare and occurs in 2%to 4% of the cases (Browne 2005). Although histologically similarto bladder TCCs, upper tract transitional cell carcinoma is moreaggressive tumours with a tendency to multifocality, local recur-rence and progression to an advanced stage (David 2002; Browne2005; Muntener 2007).The risk of upper tract TCCs increase with age and commonly oc-cur between the sixth and seventh decade of life. Men have a two tothree times more risk of developing upper tract TCCs as comparedto women (David 2002; Campbell-Wash 2003). Cigarette smok-ing is the most significant acquired risk factor for upper-tract TCCs(Jensen 1988; McLaughlin 1992). Balkan endemic nephropathy(Petkovic 1975), analgesic abuse (particularly phenacetin) (Mc-Credie 1982), exposure to chemical, petrochemical, aniline dye,coal, coke, tar, asphalt and plastic industry workers (Jensen 1988),chronic bacterial infection, and chemotherapy drugs (cyclophos-phamide and ifosfamide), have all been implicated.Upper tract transitional cell carcinoma is rarely asymptomatic.Frank or microscopic haematuria is the commonest presentationfollowed by loin pain (Campbell-Wash 2003). Other clinical pre-sentations include renal colic, palpable mass, weight loss, anorexia,and bone pain (Campbell-Wash 2003).Diagnosis is based on clinical, cytological, endoscopic and imaginggrounds (Johnson 2005; Painter 2007). Useful imaging modalitiesinclude, retrograde pyelography, renal USS, CT and MR Urogra-phy (Browne 2005). Stage and grade at presentation dictate prog-nosis, with staging being the single most important prognosticindicator (Olgac 2004).Open nephroureterectomy (ONU) has been the standard surgicaloption for upper-tract TCCs with a normally functioning con-tralateral collecting system. The procedure itself consists of totalnephrouretectomy with excision of the bladder cuff around theureteric orifices to prevent tumour recurrence in the ureteric stumpor around the ipsilateral ureteric orifice. The procedure entails ei-ther two long incisions or single long incisions for adequate ex-posure. As a result there is significant morbidity in the form post-operative pain and therefore prolonged hospitalisation (Rassweiler2004).There has been considerable advancement in minimal invasivesurgery in recent years to counter issues of post-operative pain,prolonged hospitalisation associated with ONU. Some of the vi-able options include laparoscopic nephroureterectomy (LNU),ureteroscopic resection/fulgaration or percutaneous management.Reports have proven that LNU that has reduced morbidity signifi-cantly as compared to ONU and the long term oncological efficacyof LNU are similar to ONU (David 2002; El-Fettouh 2002; Bariol2004; Rassweiler 2004; Arancibia 2007; Busby 2007; Muntener2007). For these reasons LNU is steadily becoming the standardprocedure of choice for upper tract TCCs especially bulky, largesized tumours in various centres.With the recent development of sophisticated ureteroscopes, en-doscopic management of low grade lesions measuring <1.5 cmwith normal controlateral kidneys has been reported in variousstudies to be a very favourable option (David 2002; Johnson 2005;Soderdahl 2005; Mugiya 2006). However the need for long-termsurveillance and patient suitability are limiting factors .Laser ther-apy and electrocautery are the commonly used modes in these set-tings. Adjuvant topical therapy (mitomycin, BCG, etc) has beensuggested to reduce recurrence of disease following endoscopictherapy (Keeley 1997).Percutaneous approach combined with resection of the tumourshas been suggested in some reports to be a useful option in lowgrade, large tumours (Jabbour 2000; Soderdahl 2005). For pa-tients with solitary, bilateral tumours, severe renal insufficiencyand severe co-morbidities, partial nephrectomy, segmental ureteralresection with re-anastomosis or ureteroscopic management, aresurgical options. (Campbell-Wash 2003; Johnson 2005).Furthermore, there are various techniques described to deal withthe lower end of the ureter during nephroureterectomy such asopen excision, laparoscopic or endoscopic assisted methods. How-ever there is no consensus on the best way to deal with lower endand surgical practice remains an issue of surgeon’s preference andexperience.O B J E C T I V E STo determine the best surgical management of upper tract transi-tional cell carcinoma.The following comparisons are pre-stated:1.Whether open radical nephroureterectomy is better than laparo-scopic nephroureterectomy2.Whether nephroureterectomy is better than conservative lo-calised resection of ureter, where indicated3. Whether open surgical resection (local or nephroureterectomy)is better than endoscopic resection and surveillance, where indi-cated4.Whether open surgical method of handling lower end of ureteris better than endoscopic or laproscopic assisted methodsM E T H O D S2Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.Criteria for considering studies for this reviewTypes of studiesAll randomised or quasi-randomised controlled trials comparingthe various surgical methods and approaches for the managementof localised upper tract transitional cell carcinoma.Types of participantsAll adult patients with localised transitional cell carcinoma. Lo-calised disease is defined as limited to the kidney or ureter with nogross lymph nodal enlargement on imaging.Types of interventionsAny surgical method or approach for managing localised renal cellcarcinoma.Types of outcome measuresVarious outcomes of interest are:EARLY SURGICAL OUTCOMENeed for re-operationOperative complicationsPost-operative morbidity / mortalityLength of operationLength of hospital stayDuration of catheterizationAnalgesic requirementPositive surgical margins (local resection of ureter)CANCER OUTCOME MEASURESOverall survivalCancer-specific survivalPositive margin rateIncidence of local recurrence or progressionIncidence of distant metastasisHEALTH-RELATED QUALITY OF LIFE (HRQOL) OUT-COME MEASURESGeneric HRQOL measures (e.g. SF-36 Ware 1992)Disease-specific HRQOL measures (e.g. UCLA PCI Litwin 1998)HEALTH ECONOMIC OUTCOME MEASURESResource implications of differences in outcomesResource implications of differences in impact on HRQOLFormal economic analysis (cost utility)Length of hospital stay (days) and associated costs (in GBP)Search methods for identification of studiesA sensitive search strategy will be devloped to identify relevantstudies for inclusion in this review . The following search terms willbe used in conjunction with the Cochrane highly sensitive searchstrategy for RCTs as described in the Cochrane Handbook forSystematic Reviews of Interventions (designed in OVID versionof MEDLINE).1. exp Carcinoma, Transitional Cell/2. exp Ureteral Neoplasms/3. ((upper tract or renal pelv$ or ureter$ or calice$) adj3(transitional or carcinoma$or tumo?r$ or cancer$ orneoplas$)).tw.4. or/1-35. exp Surgery/6. nephroureterectom$.tw.7. ((ureteral or percutaneous or surgical or ureteroscopic orendoscopic) adj3 (resection or managament or fulgaration)).tw.8. (ONU or LNU).tw.9. ((radical or open or laparoscop$) adj3 (surg$ or nephro$ ornephrec)).tw.10. partial nephrectomy.tw.11. exp Electrocoagulation/12. exp Laser Therapy/13. re-anastomosis.tw.14. electrocaut$.tw.15. or/5-1416. 4 and 15This MEDLINE strategy will then be translated and the followingelectronic databases searched:1. EMBASE2. Cochrane Library3. CINAHL4. British Nursing Index5. AMED6. LILACS7. Web of Science8. Scopus9. Biosis10. TRIP11. Biomed Central12. Dissertation Abstracts13. ISI proceedingsIn addition, trial registers and a variety of internet sites will besearched looking for meeting abstracts and other grey literature.Data collection and analysisThe literature search will be screened, and by consensus, relevantarticles retrieved using above search strategy. Data will be extractedfrom each identified paper independently by two or more review-ers and cross checked. The extracted data will include informationon trial design, participants, the type of intervention and outcomemeasures. Data analysis will compare radical surgery with otherprimary surgical modalities and comparisons made for each out-come. Also comparisons will be made between different surgical3Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.approaches. The quality of each trial will be graded according tothe concealment of allocation and adequate descriptions of num-bers and reasons for patient withdrawal as detailed in the CochraneHandbook.The data analysis will be performed using Review manager. Com-parable data from each trial will be combined in a meta-analysiswhere possible. For dichotomous data, relative risks (RRs) with95% confidence intervals (CI) will be estimated based on the fixedeffects model (and on the random effects model when hetero-geneity is present) and according to an intention to treat analysis.Continuous outcomes will be analyzed if the mean and standarddeviation of endpoint measures are presented. For the meta-analy-sis of continuous outcomes, weighted mean differences (WMDs)between groups will generally be estimated.W H A T ’ S N E WLast assessed as up-to-date: 21 April 2008.8 May 2008 Amended Converted to new review format.H I S T O R YProtocol first published: Issue 4, 200821 February 2008 New citation required and major changes Substantive amendmentD E C L A R A T I O N S O F I N T E R E S TNone.4Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Surgical management for upper tract transitional cell carcinoma

                                                                    University of DundeeSurgical management for upper tract transitional cell carcinomaRai, Bhavan Prasad; Cohen, Nicholas P.; Shelley, Mike; N'Dow, James M. O.; McClinton,Samuel; Nabi, GhulamPublished in:Cochrane Database of Systematic ReviewsDOI:10.1002/14651858.CD007349Publication date:2008Document VersionPublisher's PDF, also known as Version of recordLink to publication in Discovery Research PortalCitation for published version (APA):Rai, B. P., Cohen, N. P., Shelley, M., N'Dow, J. M. O., McClinton, S., Nabi, G., & British Association of UrologicalSurgeons Section of Oncology (2008). Surgical management for upper tract transitional cell carcinoma.Cochrane Database of Systematic Reviews, (4), [CD007349]. https://doi.org/10.1002/14651858.CD007349General rightsCopyright and moral rights for the publications made accessible in Discovery Research Portal are retained by the authors and/or othercopyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated withthese rights. • Users may download and print one copy of any publication from Discovery Research Portal for the purpose of private study or research. • You may not further distribute the material or use it for any profit-making activity or commercial gain. • You may freely distribute the URL identifying the publication in the public portal.Take down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Download date: 18. Apr. 2023Surgical management for upper tract transitional cellcarcinoma (Protocol)Rai BP, Cohen NP, Shelley M, N’Dow JMO, McClinton S, Nabi G, British Association ofUrological Surgeons (BAUS), Section of OncologyThis is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The CochraneLibrary 2008, Issue 4http://www.thecochranelibrary.comSurgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.T A B L E O F C O N T E N T S1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iSurgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.[Intervention Protocol]Surgical management for upper tract transitional cellcarcinomaBhavan Prasad Rai2 , Nicholas P Cohen3, Mike Shelley4, James MO N’Dow5, Samuel McClinton6 , Ghulam Nabi1, British Associationof Urological Surgeons (BAUS), Section of Oncology71Academic Urology Unit, University of Aberdeen, Aberdeen, UK. 2Urology, ARI, Aberdeen, UK. 3urology, Aberdeen, UK. 4CochraneProstatic Diseases and Urological Cancers Unit, Research Dept, Velindre NHS Trust, Cardiff, UK. 5Ward 44, Aberdeen Royal Infirmary,NHS Trust, Aberdeen, UK. 6Department of Urology, Ward 44, Aberdeen Royal Infirmary, Aberdeen, UK. 7London, UKContact address: Ghulam Nabi, Academic Urology Unit, University of Aberdeen, 1st Floor Health Sciences Building, Foresterhill,Aberdeen, AB25 2ZD, UK. g.nabi@abdn.ac.uk.Editorial group: Cochrane Prostatic Diseases and Urologic Cancers Group.Publication status and date: New, published in Issue 4, 2008.Citation: Rai BP, Cohen NP, Shelley M, N’Dow JMO, McClinton S, Nabi G, British Association of Urological Surgeons (BAUS),Section of Oncology. Surgical management for upper tract transitional cell carcinoma. Cochrane Database of Systematic Reviews 2008,Issue 4. Art. No.: CD007349. DOI: 10.1002/14651858.CD007349.Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.A B S T R A C TThis is the protocol for a review and there is no abstract. The objectives are as follows:To determine the best surgical management of upper tract transitional cell carcinoma.The following comparisons are pre-stated:1.Whether open radical nephroureterectomy is better than laparoscopic nephroureterectomy2.Whether nephroureterectomy is better than conservative localised resection of ureter, where indicated3. Whether open surgical resection (local or nephroureterectomy) is better than endoscopic resection and surveillance, where indicated4.Whether open surgical method of handling lower end of ureter is better than endoscopic or laproscopic assisted methods1Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.B A C K G R O U N DUpper tract transitional cell carcinoma (TCC) arises from the re-nal pelvis, calices and ureters. These tumours are uncommon andconstitute only 5% of TCCs of the entire renal tract (Campbell-Wash 2003). TCCs of the renal pelvis account for 10% of all re-nal tumours and ureteric TCCs are even less common (El-Fet-touh 2002). Bilateral disease is extremely rare and occurs in 2%to 4% of the cases (Browne 2005). Although histologically similarto bladder TCCs, upper tract transitional cell carcinoma is moreaggressive tumours with a tendency to multifocality, local recur-rence and progression to an advanced stage (David 2002; Browne2005; Muntener 2007).The risk of upper tract TCCs increase with age and commonly oc-cur between the sixth and seventh decade of life. Men have a two tothree times more risk of developing upper tract TCCs as comparedto women (David 2002; Campbell-Wash 2003). Cigarette smok-ing is the most significant acquired risk factor for upper-tract TCCs(Jensen 1988; McLaughlin 1992). Balkan endemic nephropathy(Petkovic 1975), analgesic abuse (particularly phenacetin) (Mc-Credie 1982), exposure to chemical, petrochemical, aniline dye,coal, coke, tar, asphalt and plastic industry workers (Jensen 1988),chronic bacterial infection, and chemotherapy drugs (cyclophos-phamide and ifosfamide), have all been implicated.Upper tract transitional cell carcinoma is rarely asymptomatic.Frank or microscopic haematuria is the commonest presentationfollowed by loin pain (Campbell-Wash 2003). Other clinical pre-sentations include renal colic, palpable mass, weight loss, anorexia,and bone pain (Campbell-Wash 2003).Diagnosis is based on clinical, cytological, endoscopic and imaginggrounds (Johnson 2005; Painter 2007). Useful imaging modalitiesinclude, retrograde pyelography, renal USS, CT and MR Urogra-phy (Browne 2005). Stage and grade at presentation dictate prog-nosis, with staging being the single most important prognosticindicator (Olgac 2004).Open nephroureterectomy (ONU) has been the standard surgicaloption for upper-tract TCCs with a normally functioning con-tralateral collecting system. The procedure itself consists of totalnephrouretectomy with excision of the bladder cuff around theureteric orifices to prevent tumour recurrence in the ureteric stumpor around the ipsilateral ureteric orifice. The procedure entails ei-ther two long incisions or single long incisions for adequate ex-posure. As a result there is significant morbidity in the form post-operative pain and therefore prolonged hospitalisation (Rassweiler2004).There has been considerable advancement in minimal invasivesurgery in recent years to counter issues of post-operative pain,prolonged hospitalisation associated with ONU. Some of the vi-able options include laparoscopic nephroureterectomy (LNU),ureteroscopic resection/fulgaration or percutaneous management.Reports have proven that LNU that has reduced morbidity signifi-cantly as compared to ONU and the long term oncological efficacyof LNU are similar to ONU (David 2002; El-Fettouh 2002; Bariol2004; Rassweiler 2004; Arancibia 2007; Busby 2007; Muntener2007). For these reasons LNU is steadily becoming the standardprocedure of choice for upper tract TCCs especially bulky, largesized tumours in various centres.With the recent development of sophisticated ureteroscopes, en-doscopic management of low grade lesions measuring <1.5 cmwith normal controlateral kidneys has been reported in variousstudies to be a very favourable option (David 2002; Johnson 2005;Soderdahl 2005; Mugiya 2006). However the need for long-termsurveillance and patient suitability are limiting factors .Laser ther-apy and electrocautery are the commonly used modes in these set-tings. Adjuvant topical therapy (mitomycin, BCG, etc) has beensuggested to reduce recurrence of disease following endoscopictherapy (Keeley 1997).Percutaneous approach combined with resection of the tumourshas been suggested in some reports to be a useful option in lowgrade, large tumours (Jabbour 2000; Soderdahl 2005). For pa-tients with solitary, bilateral tumours, severe renal insufficiencyand severe co-morbidities, partial nephrectomy, segmental ureteralresection with re-anastomosis or ureteroscopic management, aresurgical options. (Campbell-Wash 2003; Johnson 2005).Furthermore, there are various techniques described to deal withthe lower end of the ureter during nephroureterectomy such asopen excision, laparoscopic or endoscopic assisted methods. How-ever there is no consensus on the best way to deal with lower endand surgical practice remains an issue of surgeon’s preference andexperience.O B J E C T I V E STo determine the best surgical management of upper tract transi-tional cell carcinoma.The following comparisons are pre-stated:1.Whether open radical nephroureterectomy is better than laparo-scopic nephroureterectomy2.Whether nephroureterectomy is better than conservative lo-calised resection of ureter, where indicated3. Whether open surgical resection (local or nephroureterectomy)is better than endoscopic resection and surveillance, where indi-cated4.Whether open surgical method of handling lower end of ureteris better than endoscopic or laproscopic assisted methodsM E T H O D S2Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.Criteria for considering studies for this reviewTypes of studiesAll randomised or quasi-randomised controlled trials comparingthe various surgical methods and approaches for the managementof localised upper tract transitional cell carcinoma.Types of participantsAll adult patients with localised transitional cell carcinoma. Lo-calised disease is defined as limited to the kidney or ureter with nogross lymph nodal enlargement on imaging.Types of interventionsAny surgical method or approach for managing localised renal cellcarcinoma.Types of outcome measuresVarious outcomes of interest are:EARLY SURGICAL OUTCOMENeed for re-operationOperative complicationsPost-operative morbidity / mortalityLength of operationLength of hospital stayDuration of catheterizationAnalgesic requirementPositive surgical margins (local resection of ureter)CANCER OUTCOME MEASURESOverall survivalCancer-specific survivalPositive margin rateIncidence of local recurrence or progressionIncidence of distant metastasisHEALTH-RELATED QUALITY OF LIFE (HRQOL) OUT-COME MEASURESGeneric HRQOL measures (e.g. SF-36 Ware 1992)Disease-specific HRQOL measures (e.g. UCLA PCI Litwin 1998)HEALTH ECONOMIC OUTCOME MEASURESResource implications of differences in outcomesResource implications of differences in impact on HRQOLFormal economic analysis (cost utility)Length of hospital stay (days) and associated costs (in GBP)Search methods for identification of studiesA sensitive search strategy will be devloped to identify relevantstudies for inclusion in this review . The following search terms willbe used in conjunction with the Cochrane highly sensitive searchstrategy for RCTs as described in the Cochrane Handbook forSystematic Reviews of Interventions (designed in OVID versionof MEDLINE).1. exp Carcinoma, Transitional Cell/2. exp Ureteral Neoplasms/3. ((upper tract or renal pelv$ or ureter$ or calice$) adj3(transitional or carcinoma$or tumo?r$ or cancer$ orneoplas$)).tw.4. or/1-35. exp Surgery/6. nephroureterectom$.tw.7. ((ureteral or percutaneous or surgical or ureteroscopic orendoscopic) adj3 (resection or managament or fulgaration)).tw.8. (ONU or LNU).tw.9. ((radical or open or laparoscop$) adj3 (surg$ or nephro$ ornephrec)).tw.10. partial nephrectomy.tw.11. exp Electrocoagulation/12. exp Laser Therapy/13. re-anastomosis.tw.14. electrocaut$.tw.15. or/5-1416. 4 and 15This MEDLINE strategy will then be translated and the followingelectronic databases searched:1. EMBASE2. Cochrane Library3. CINAHL4. British Nursing Index5. AMED6. LILACS7. Web of Science8. Scopus9. Biosis10. TRIP11. Biomed Central12. Dissertation Abstracts13. ISI proceedingsIn addition, trial registers and a variety of internet sites will besearched looking for meeting abstracts and other grey literature.Data collection and analysisThe literature search will be screened, and by consensus, relevantarticles retrieved using above search strategy. Data will be extractedfrom each identified paper independently by two or more review-ers and cross checked. The extracted data will include informationon trial design, participants, the type of intervention and outcomemeasures. Data analysis will compare radical surgery with otherprimary surgical modalities and comparisons made for each out-come. Also comparisons will be made between different surgical3Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.approaches. The quality of each trial will be graded according tothe concealment of allocation and adequate descriptions of num-bers and reasons for patient withdrawal as detailed in the CochraneHandbook.The data analysis will be performed using Review manager. Com-parable data from each trial will be combined in a meta-analysiswhere possible. For dichotomous data, relative risks (RRs) with95% confidence intervals (CI) will be estimated based on the fixedeffects model (and on the random effects model when hetero-geneity is present) and according to an intention to treat analysis.Continuous outcomes will be analyzed if the mean and standarddeviation of endpoint measures are presented. For the meta-analy-sis of continuous outcomes, weighted mean differences (WMDs)between groups will generally be estimated.W H A T ’ S N E WLast assessed as up-to-date: 21 April 2008.8 May 2008 Amended Converted to new review format.H I S T O R YProtocol first published: Issue 4, 200821 February 2008 New citation required and major changes Substantive amendmentD E C L A R A T I O N S O F I N T E R E S TNone.4Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Crossref

                                                              University of DundeeSurgical management for upper tract transitional cell carcinomaRai, Bhavan Prasad; Cohen, Nicholas P.; Shelley, Mike; N'Dow, James M. O.; McClinton,Samuel; Nabi, Ghulam; British Association of Urological Surgeons Section of OncologyPublished in:Cochrane Database of Systematic ReviewsDOI:10.1002/14651858.CD007349Publication date:2008Document VersionPublisher's PDF, also known as Version of recordLink to publication in Discovery Research PortalCitation for published version (APA):Rai, B. P., Cohen, N. P., Shelley, M., N'Dow, J. M. O., McClinton, S., Nabi, G., & British Association of UrologicalSurgeons Section of Oncology (2008). Surgical management for upper tract transitional cell carcinoma.Cochrane Database of Systematic Reviews, (4), [CD007349]. 10.1002/14651858.CD007349General rightsCopyright and moral rights for the publications made accessible in Discovery Research Portal are retained by the authors and/or othercopyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated withthese rights. • Users may download and print one copy of any publication from Discovery Research Portal for the purpose of private study or research. • You may not further distribute the material or use it for any profit-making activity or commercial gain. • You may freely distribute the URL identifying the publication in the public portal.Take down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Download date: 16. Mar. 2016Surgical management for upper tract transitional cellcarcinoma (Protocol)Rai BP, Cohen NP, Shelley M, N’Dow JMO, McClinton S, Nabi G, British Association ofUrological Surgeons (BAUS), Section of OncologyThis is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The CochraneLibrary 2008, Issue 4http://www.thecochranelibrary.comSurgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.T A B L E O F C O N T E N T S1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iSurgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.[Intervention Protocol]Surgical management for upper tract transitional cellcarcinomaBhavan Prasad Rai2 , Nicholas P Cohen3, Mike Shelley4, James MON’Dow5, Samuel McClinton6 , Ghulam Nabi1, British Associationof Urological Surgeons (BAUS), Section of Oncology71Academic Urology Unit, University of Aberdeen, Aberdeen, UK. 2Urology, ARI, Aberdeen, UK. 3urology, Aberdeen, UK. 4CochraneProstatic Diseases andUrological Cancers Unit, ResearchDept, Velindre NHSTrust, Cardiff, UK. 5Ward 44, Aberdeen Royal Infirmary,NHS Trust, Aberdeen, UK. 6Department of Urology, Ward 44, Aberdeen Royal Infirmary, Aberdeen, UK. 7London, UKContact address: Ghulam Nabi, Academic Urology Unit, University of Aberdeen, 1st Floor Health Sciences Building, Foresterhill,Aberdeen, AB25 2ZD, UK. g.nabi@abdn.ac.uk.Editorial group: Cochrane Prostatic Diseases and Urologic Cancers Group.Publication status and date: New, published in Issue 4, 2008.Citation: Rai BP, Cohen NP, Shelley M, N’Dow JMO, McClinton S, Nabi G, British Association of Urological Surgeons (BAUS),Section of Oncology. Surgical management for upper tract transitional cell carcinoma. Cochrane Database of Systematic Reviews 2008,Issue 4. Art. No.: CD007349. DOI: 10.1002/14651858.CD007349.Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.A B S T R A C TThis is the protocol for a review and there is no abstract. The objectives are as follows:To determine the best surgical management of upper tract transitional cell carcinoma.The following comparisons are pre-stated:1.Whether open radical nephroureterectomy is better than laparoscopic nephroureterectomy2.Whether nephroureterectomy is better than conservative localised resection of ureter, where indicated3. Whether open surgical resection (local or nephroureterectomy) is better than endoscopic resection and surveillance, where indicated4.Whether open surgical method of handling lower end of ureter is better than endoscopic or laproscopic assisted methods1Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.B A C K G R O U N DUpper tract transitional cell carcinoma (TCC) arises from the re-nal pelvis, calices and ureters. These tumours are uncommon andconstitute only 5% of TCCs of the entire renal tract (Campbell-Wash 2003). TCCs of the renal pelvis account for 10% of all re-nal tumours and ureteric TCCs are even less common (El-Fet-touh 2002). Bilateral disease is extremely rare and occurs in 2%to 4% of the cases (Browne 2005). Although histologically similarto bladder TCCs, upper tract transitional cell carcinoma is moreaggressive tumours with a tendency to multifocality, local recur-rence and progression to an advanced stage (David 2002; Browne2005; Muntener 2007).The risk of upper tract TCCs increase with age and commonly oc-cur between the sixth and seventh decade of life.Men have a two tothree times more risk of developing upper tract TCCs as comparedto women (David 2002; Campbell-Wash 2003). Cigarette smok-ing is themost significant acquired risk factor for upper-tractTCCs(Jensen 1988; McLaughlin 1992). Balkan endemic nephropathy(Petkovic 1975), analgesic abuse (particularly phenacetin) (Mc-Credie 1982), exposure to chemical, petrochemical, aniline dye,coal, coke, tar, asphalt and plastic industry workers (Jensen 1988),chronic bacterial infection, and chemotherapy drugs (cyclophos-phamide and ifosfamide), have all been implicated.Upper tract transitional cell carcinoma is rarely asymptomatic.Frank or microscopic haematuria is the commonest presentationfollowed by loin pain (Campbell-Wash 2003). Other clinical pre-sentations include renal colic, palpablemass, weight loss, anorexia,and bone pain (Campbell-Wash 2003).Diagnosis is based on clinical, cytological, endoscopic and imaginggrounds (Johnson 2005; Painter 2007). Useful imaging modalitiesinclude, retrograde pyelography, renal USS, CT and MR Urogra-phy (Browne 2005). Stage and grade at presentation dictate prog-nosis, with staging being the single most important prognosticindicator (Olgac 2004).Open nephroureterectomy (ONU) has been the standard surgicaloption for upper-tract TCCs with a normally functioning con-tralateral collecting system. The procedure itself consists of totalnephrouretectomy with excision of the bladder cuff around theureteric orifices to prevent tumour recurrence in the ureteric stumpor around the ipsilateral ureteric orifice. The procedure entails ei-ther two long incisions or single long incisions for adequate ex-posure. As a result there is significant morbidity in the form post-operative pain and therefore prolonged hospitalisation (Rassweiler2004).There has been considerable advancement in minimal invasivesurgery in recent years to counter issues of post-operative pain,prolonged hospitalisation associated with ONU. Some of the vi-able options include laparoscopic nephroureterectomy (LNU),ureteroscopic resection/fulgaration or percutaneous management.Reports have proven that LNU that has reducedmorbidity signifi-cantly as compared toONUand the long term oncological efficacyof LNUare similar toONU (David 2002; El-Fettouh 2002; Bariol2004; Rassweiler 2004; Arancibia 2007; Busby 2007; Muntener2007). For these reasons LNU is steadily becoming the standardprocedure of choice for upper tract TCCs especially bulky, largesized tumours in various centres.With the recent development of sophisticated ureteroscopes, en-doscopic management of low grade lesions measuring <1.5 cmwith normal controlateral kidneys has been reported in variousstudies to be a very favourable option (David 2002; Johnson 2005;Soderdahl 2005; Mugiya 2006). However the need for long-termsurveillance and patient suitability are limiting factors .Laser ther-apy and electrocautery are the commonly used modes in these set-tings. Adjuvant topical therapy (mitomycin, BCG, etc) has beensuggested to reduce recurrence of disease following endoscopictherapy (Keeley 1997).Percutaneous approach combined with resection of the tumourshas been suggested in some reports to be a useful option in lowgrade, large tumours (Jabbour 2000; Soderdahl 2005). For pa-tients with solitary, bilateral tumours, severe renal insufficiencyand severe co-morbidities, partial nephrectomy, segmental ureteralresection with re-anastomosis or ureteroscopic management, aresurgical options. (Campbell-Wash 2003; Johnson 2005).Furthermore, there are various techniques described to deal withthe lower end of the ureter during nephroureterectomy such asopen excision, laparoscopic or endoscopic assisted methods. How-ever there is no consensus on the best way to deal with lower endand surgical practice remains an issue of surgeon’s preference andexperience.O B J E C T I V E STo determine the best surgical management of upper tract transi-tional cell carcinoma.The following comparisons are pre-stated:1.Whether open radical nephroureterectomy is better than laparo-scopic nephroureterectomy2.Whether nephroureterectomy is better than conservative lo-calised resection of ureter, where indicated3. Whether open surgical resection (local or nephroureterectomy)is better than endoscopic resection and surveillance, where indi-cated4.Whether open surgical method of handling lower end of ureteris better than endoscopic or laproscopic assisted methodsM E T H O D S2Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.Criteria for considering studies for this reviewTypes of studiesAll randomised or quasi-randomised controlled trials comparingthe various surgical methods and approaches for the managementof localised upper tract transitional cell carcinoma.Types of participantsAll adult patients with localised transitional cell carcinoma. Lo-calised disease is defined as limited to the kidney or ureter with nogross lymph nodal enlargement on imaging.Types of interventionsAny surgical method or approach for managing localised renal cellcarcinoma.Types of outcome measuresVarious outcomes of interest are:EARLY SURGICAL OUTCOMENeed for re-operationOperative complicationsPost-operative morbidity / mortalityLength of operationLength of hospital stayDuration of catheterizationAnalgesic requirementPositive surgical margins (local resection of ureter)CANCER OUTCOME MEASURESOverall survivalCancer-specific survivalPositive margin rateIncidence of local recurrence or progressionIncidence of distant metastasisHEALTH-RELATED QUALITY OF LIFE (HRQOL) OUT-COME MEASURESGeneric HRQOL measures (e.g. SF-36 Ware 1992)Disease-specific HRQOLmeasures (e.g. UCLA PCI Litwin 1998)HEALTH ECONOMIC OUTCOME MEASURESResource implications of differences in outcomesResource implications of differences in impact on HRQOLFormal economic analysis (cost utility)Length of hospital stay (days) and associated costs (in GBP)Search methods for identification of studiesA sensitive search strategy will be devloped to identify relevantstudies for inclusion in this review . The following search termswillbe used in conjunction with the Cochrane highly sensitive searchstrategy for RCTs as described in the Cochrane Handbook forSystematic Reviews of Interventions (designed in OVID versionof MEDLINE).1. exp Carcinoma, Transitional Cell/2. exp Ureteral Neoplasms/3. ((upper tract or renal pelv$ or ureter$ or calice$) adj3(transitional or carcinoma$or tumo?r$ or cancer$ orneoplas$)).tw.4. or/1-35. exp Surgery/6. nephroureterectom$.tw.7. ((ureteral or percutaneous or surgical or ureteroscopic orendoscopic) adj3 (resection or managament or fulgaration)).tw.8. (ONU or LNU).tw.9. ((radical or open or laparoscop$) adj3 (surg$ or nephro$ ornephrec)).tw.10. partial nephrectomy.tw.11. exp Electrocoagulation/12. exp Laser Therapy/13. re-anastomosis.tw.14. electrocaut$.tw.15. or/5-1416. 4 and 15ThisMEDLINE strategy will then be translated and the followingelectronic databases searched:1. EMBASE2. Cochrane Library3. CINAHL4. British Nursing Index5. AMED6. LILACS7. Web of Science8. Scopus9. Biosis10. TRIP11. Biomed Central12. Dissertation Abstracts13. ISI proceedingsIn addition, trial registers and a variety of internet sites will besearched looking for meeting abstracts and other grey literature.Data collection and analysisThe literature search will be screened, and by consensus, relevantarticles retrieved using above search strategy. Data will be extractedfrom each identified paper independently by two or more review-ers and cross checked. The extracted data will include informationon trial design, participants, the type of intervention and outcomemeasures. Data analysis will compare radical surgery with otherprimary surgical modalities and comparisons made for each out-come. Also comparisons will be made between different surgical3Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.approaches. The quality of each trial will be graded according tothe concealment of allocation and adequate descriptions of num-bers and reasons for patient withdrawal as detailed in theCochraneHandbook.The data analysis will be performed using Review manager. Com-parable data from each trial will be combined in a meta-analysiswhere possible. For dichotomous data, relative risks (RRs) with95% confidence intervals (CI) will be estimated based on the fixedeffects model (and on the random effects model when hetero-geneity is present) and according to an intention to treat analysis.Continuous outcomes will be analyzed if the mean and standarddeviation of endpoint measures are presented. For the meta-analy-sis of continuous outcomes, weighted mean differences (WMDs)between groups will generally be estimated.WH A T ’ S N E WLast assessed as up-to-date: 21 April 2008.8 May 2008 Amended Converted to new review format.H I S T O R YProtocol first published: Issue 4, 200821 February 2008 New citation required and major changes Substantive amendmentD E C L A R A T I O N S O F I N T E R E S TNone.4Surgical management for upper tract transitional cell carcinoma (Protocol)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Surgical management for upper tract transitional cell carcinoma

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