Chuttani, Ram

Mosko, Jeffrey D.

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 EPISOD puts an end to sphincter of Oddi dysfunction type III  (Article begins on next page)The Harvard community has made this article openly available.Please share how this access benefits you. Your story matters.Citation Mosko, Jeffrey D., and Ram Chuttani. 2014. “EPISOD puts anend to sphincter of Oddi dysfunction type III.” Annals ofGastroenterology : Quarterly Publication of the Hellenic Societyof Gastroenterology 27 (4): 427-428.Accessed February 17, 2015 3:28:03 AM ESTCitable Link http://nrs.harvard.edu/urn-3:HUL.InstRepos:13347527Terms of Use This article was downloaded from Harvard University's DASHrepository, and is made available under the terms and conditionsapplicable to Other Posted Material, as set forth athttp://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAA© 2014 Hellenic Society of Gastroenterology  www.annalsgastro.grAnnals of Gastroenterology (2014) 27, 427-428 CLINICAL OPINIONEPISOD puts an end to sphincter of Oddi dysfunction type IIIJeff  rey D. Mosko, Ram ChuttaniBeth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USASummaryTh  e Rome III revision of the Milwaukee Biliary Group classifi   cation has long been utilized to diagnose, classify and drive intervention in patients with suspected sphincter of Oddi dysfunction (SOD). SOD Type  III is defi  ned  as recurrent biliary-type pain in the absence of elevated liver enzymes and/or imaging abnormalities (common bile duct <8  mm)  [1]. While patients with SOD Type  II are more likely to have manometric evidence of SOD (55% of the time), studies have shown that only 28% of patients with SOD Type III have manometric evidence of biliary sphincter dysfunction [2]. In 1989, Geenan et al showed that 17 of 18 patients with verifi  ed SOD on manometry benefi  tted from endoscopic sphincterotomy [3]. Subsequent literature from the 1990’s revealed that patients with SOD Type  I benefi  t from sphincterotomy without the need for manometry. Th  ese studies also showed a poor correlation between the results of manometry and response to sphincterotomy [4-6]. Based on the low rate of manometric changes in SOD Type III as well as the aforementioned poor correlation of sphincter manometry with response to sphincterotomy, the optimal management for these patients remains a therapeutic challenge.In the May issue of JAMA, Cotton et al [7] present a multi-center, prospective, sham-controlled randomized trial demonstrating that endoscopic sphincterotomy did not reduce disability due to pain in patients presenting with abdominal pain (suspected SOD Type III) aft  er cholecystectomy. With over 700,000  patients undergoing cholecystectomy every year [8] and greater than 10% reporting pain aft  erwards [9], Cotton et al set out to identify if patients with SOD Type III respond to endoscopic sphincterotomy (biliary and/or pancreatic). In addition, the ability of sphincter manometry to predict outcomes was evaluated. Th   e trial was conducted at 7 tertiary centers throughout the US. Between 2008 and 2012, 214  patients (predominantly female) post-cholecystectomy with suspected SOD Type  III underwent randomization. All patients underwent ERCP, sphincter manometry and were then randomized, regardless of manometry results, to sphincterotomy (n=141) versus sham sphincterotomy (n=73). Within the sphincterotomy group, patients with pancreatic sphincter hypertension were randomized to biliary versus dual (biliary and pancreatic) sphincterotomy. Both groups received small caliber pancreatic stents but no rectal indomethacin. Th  e treatment was considered successful if the patients had a low RAPID score (<6 days of lost productivity due to pain) at 9 and 12 months, did not require a repeat ERCP, and/or did not require narcotics.Overall, the investigators found that pain and disability were reduced in both groups during 12-month follow up, yet it was the sham sphincterotomy group (37%; 95%CI 25.9-48.1%) that experienced successful treatment more oft  en than the sphincterotomy group (23%; 95%CI 15.8-29.6%). In patients with pancreatic sphincter hypertension, dual sphincterotomy (30%; 95% CI 16.7-42.9%) was equivalent to biliary sphincterotomy alone (20%; 95% CI 8.7-30.5%). No association was found between outcomes and manometry results. No specifi   c subgroups appeared to benefi  t  from sphincterotomy. Patients in an additional observational arm had the same success rates. Complication rates were reported with pancreatitis occurring in 11% and 15% of the sphincterotomy and sham groups respectively.OpinionTh  e EPISOD trial stands as the most well executed trial in patients with suspected sphincter of Oddi dysfunction to date. Among this study’s key strengths is its design. Th  e stringent inclusion/exclusion criteria ensured a specifi  c patient population. Previous studies assessed the eff  ect  of sphincterotomy on post-cholecystectomy pain but did not Title: Eff  ect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy - the EPISOD randomized clinical trialAuthors: Cotton PB, Durkalski V, Romagnuolo J, Pauls Q, Fogel E, Tarnasky P, Aliperti G, Freeman M, Kozarek R, Jamidar P, Wilcox M, Serrano J, Brawman-Mintzer O, Elta G, Mauldin P, Th   ornhill A, Hawes R, Wood-Williams A, Orrell K, Drossman D, Robuck PJournal: JAMA 2014;311:2101-2109Division of Gastroenterology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USAConfl  ict of Interest: NoneCorrespondence to: Ram Chuttani, MD, Director of Endoscopy (Chief), Interventional Gastroenterology, Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA, Tel.: +617 617 0162, e-mail: rchuttan@bidmc.harvard.eduReceived 4 August 2014; accepted 5 August 2014428  J. D. Mosko and R. ChuttaniAnnals of Gastroenterology 27 specifi  cally target patients with SOD type  III. Cotton et al performed a thorough assessment of psychological status and assessed for the presence of functional gastrointestinal disease at enrollment [10]. While it is known that patients with SOD oft  en carry these comorbid conditions [11], there is no prior literature connecting their presence and the response to endoscopic therapy. Th   e authors were able to fi  rmly establish, as well as disprove a common misconception, that the presence of functional digestive disease does not predict the response to sphincterotomy. Finally, the authors chose objective, comprehensive and clinically relevant defi  nitions of success/failure of the study intervention. Th   ey were also able to show that their conclusions remained in post-hoc analyses using less stringent defi  nitions. Th  e fact that prior sphincterotomy studies used re-intervention alone as an objective measure of treatment failure may account for previous positive results. It is possible that repeat endoscopic interventions were avoided due to their procedural risks and thus patients who were truly treatment failures were considered to be treatment successes.Th   ere were very few shortcomings to this study. All patients underwent pancreatograms, an uncommon practice unless specifi   cally indicated, during ERCP to rule out pancreas divisum (an exclusion criterion). As well, to reduce the risk of post-ERCP pancreatitis, pancreatic stents were placed. Rectal indomethacin, which had not yet become the standard of care for patients at high risk for post-ERCP pancreatitis [12], was not used. In spite of this, the rate of pancreatitis was not signifi  cantly diff  erent than a recent meta-analysis reporting post-ERCP pancreatitis rate of 10% in patients with SOD versus 4% in those without [13].So where does this leave us? Th  e EPISOD trial has substantiated our knowledge regarding the ineff  ectiveness of endoscopic sphincterotomy in patients with SOD Type  III. Th  e fi  ndings by Cotton et al should have major implications for the current paradigms of endoscopic intervention in post-cholecystectomy patients with ongoing pain (suspected SOD Type III) to the point that these patients should no longer be off  ered ERCP and sphincterotomy. It has also led to the questioning of whether or not SOD Type III should remain a clinical entity altogether. If such patients have normal liver enzymes, no evidence of biliary dilation and do not respond to sphincterotomy, can their pain be attributed to true sphincter dysfunction? Should it be considered biliary at all? Finally, the discordance between manometry results and response to sphincterotomy calls sphincter manometry itself into question as the gold or even reference [14] standard for the diagnosis of SOD. It is unreliable in SOD Type I and now appears to be futile in SOD Type III (and potentially Type II). To this end, the results of prior studies that used sphincter manometry as the standard by which non-invasive modalities (e.g. HIDA scans) were measured require re-evaluation. Th  e Rome III consensus conference statement (2006) suggesting that patients with post-cholecystectomy pain should undergo liver and pancreatic biochemical tests followed by ultrasound, MRCP, and then ERCP with sphincter manometry where appropriate [15] remains intact but the number of patients where this applies has been drastically reduced. We would urge physicians to carefully evaluate patients with “biliary pain” post-cholecystectomy and use the robust conclusions from this study to guide their practice and avoid further harm to this challenging group of patients.References1.  Hogan WJ, Geenen JE. Biliary dyskinesia. Endoscopy 1988;20(Suppl 1):179.2.  Baillie J. Sphincter of Oddi dysfunction: Overdue for an overhaul. Am J Gastroenterol 2005;100:1217-1220.3.  Geenen JE, Hogan WJ, Dodds WJ, et al. Th  e  effi   cacy of endoscopic sphincterotomy aft  er cholecystectomy in patients with sphincter-of-Oddi dysfunction. N Engl J Med 1989;320:82-87.4.  Botoman VA, Kozarek RA, Novell LA, et al. Long-term outcome aft   er endoscopic sphincterotomy in patients with biliary colic and suspected sphincter of Oddi dysfunction. Gastrointest Endosc 1994;40:165-170.5. Bozkurt T, Orth KH, Butsch B, Lux G. Long-term clinical outcome of post-cholecystectomy patients with biliary-type pain: results of manometry, non-invasive techniques and endoscopic sphincterotomy. Eur J Gastroenterol Hepatol 1996;8:245-249.6.  Wehrmann T, Wiemer K, Lembcke B, et al. Do patients with sphincter of Oddi dysfunction benefi   t from endoscopic sphincterotomy? A 5-year prospective trial. Eur J  Gastroenterol Hepatol 1996;8:251-256.7.  Cotton PB, Durkalski V, Romagnuolo J, et al. Eff  ect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy. JAMA 2014;311:2101-2109.8.  Duncan CB, Riall TS. Evidence-based current surgical practice: calculous gallbladder disease. J  Gastrointest Surg 2012;16:2011-2025.9. Berger MY, Olde Hartman TC, Bohnen AM. Abdominal symptoms: do they disappear aft  er cholecystectomy? Surg Endosc 2003;17:1723-1728.10. Cotton PB, Durkalski V, Orrell KB, et al. Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction. Gastrointest Endosc 2010;72:986-991.11. Okolo P, Sherman S, Lehman GA, et al. Psychometric profi  les of patients with sphincter of Oddi dysfunction. Gastrointest Endosc 1994;40:119.12. Elmunzer BJ, Scheiman JM, Lehman GA, et al. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med 2012;366:1414-1422.13.  Masci E, Mariani A, Curioni S, Testoni PA. Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis. Endoscopy 2003;35:830-834.14.  Haber GB. Sphincter of Oddi manometry: still a valid gold standard? Endoscopy 2010;42:413-415.15. Behar J, Corazziari E, Guelrud M, et al. Functional gallbladder and sphincter of Oddi disorders. Gastroenterology 2006;130:1498-1509.

EPISOD puts an end to sphincter of Oddi dysfunction type III

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EPISOD puts an end to sphincter of Oddi dysfunction type III

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