165 research outputs found

    Outcomes and risk score for distal pancreatectomy with celiac axis resection (DP-CAR) : an international multicenter analysis

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    Background: Distal pancreatectomy with celiac axis resection (DP-CAR) is a treatment option for selected patients with pancreatic cancer involving the celiac axis. A recent multicenter European study reported a 90-day mortality rate of 16%, highlighting the importance of patient selection. The authors constructed a risk score to predict 90-day mortality and assessed oncologic outcomes. Methods: This multicenter retrospective cohort study investigated patients undergoing DP-CAR at 20 European centers from 12 countries (model design 2000-2016) and three very-high-volume international centers in the United States and Japan (model validation 2004-2017). The area under receiver operator curve (AUC) and calibration plots were used for validation of the 90-day mortality risk model. Secondary outcomes included resection margin status, adjuvant therapy, and survival. Results: For 191 DP-CAR patients, the 90-day mortality rate was 5.5% (95 confidence interval [CI], 2.2-11%) at 5 high-volume (1 DP-CAR/year) and 18% (95 CI, 9-30%) at 18 low-volume DP-CAR centers (P=0.015). A risk score with age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) score, multivisceral resection, open versus minimally invasive surgery, and low- versus high-volume center performed well in both the design and validation cohorts (AUC, 0.79 vs 0.74; P=0.642). For 174 patients with pancreatic ductal adenocarcinoma, the R0 resection rate was 60%, neoadjuvant and adjuvant therapies were applied for respectively 69% and 67% of the patients, and the median overall survival period was 19months (95 CI, 15-25months). Conclusions: When performed for selected patients at high-volume centers, DP-CAR is associated with acceptable 90-day mortality and overall survival. The authors propose a 90-day mortality risk score to improve patient selection and outcomes, with DP-CAR volume as the dominant predictor

    Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial

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    <p>Abstract</p> <p>Background</p> <p>Open transthoracic oesophagectomy is the standard treatment for infracarinal resectable oesophageal carcinomas, although it is associated with high mortality and morbidity rates of 2 to 10% and 30 to 50%, respectively, for both the abdominal and thoracic approaches. The worldwide popularity of laparoscopic techniques is based on promising results, including lower postoperative morbidity rates, which are related to the reduced postoperative trauma. We hypothesise that the laparoscopic abdominal approach (laparoscopic gastric mobilisation) in oesophageal cancer surgery will decrease the major postoperative complication rate due to the reduced surgical trauma.</p> <p>Methods/Design</p> <p>The MIRO trial is an open, controlled, prospective, randomised multicentre phase III trial. Patients in study arm A will receive laparoscopic-assisted oesophagectomy, i.e., a transthoracic oesophagectomy with two-field lymphadenectomy and laparoscopic gastric mobilisation. Patients in study arm B will receive the same procedure, but with the conventional open abdominal approach. The primary objective of the study is to evaluate the major postoperative 30-day morbidity. Secondary objectives are to assess the overall 30-day morbidity, 30-day mortality, 30-day pulmonary morbidity, disease-free survival, overall survival as well as quality of life and to perform medico-economic analysis. A total of 200 patients will be enrolled, and two safety analyses will be performed using 25 and 50 patients included in arm A.</p> <p>Discussion</p> <p>Postoperative morbidity remains high after oesophageal cancer surgery, especially due to major pulmonary complications, which are responsible for 50% of the postoperative deaths. This study represents the first randomised controlled phase III trial to evaluate the benefits of the minimally invasive approach with respect to the postoperative course and oncological outcomes in oesophageal cancer surgery.</p> <p>Trial Registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT00937456">NCT00937456</a> (ClinicalTrials.gov)</p

    A multicenter randomized-controlled trial of hypothermic oxygenated perfusion (HOPE) for human liver grafts before transplantation

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    Background &amp; Aims: Machine perfusion is a novel method intended to optimize livers before transplantation. However, its effect on morbidity within a 1-year period after transplantation has remained unclear. Methods: In this multicenter controlled trial, we randomly assigned livers donated after brain death (DBD) for liver transplantation (LT). Livers were either conventionally cold stored (control group), or cold stored and subsequently treated by 1-2 h hypothermic oxygenated perfusion (HOPE) before implantation (HOPE group). The primary endpoint was the occurrence of at least one post-transplant complication per patient, graded by the Clavien score of ≥III, within 1-year after LT. The comprehensive complication index (CCI), laboratory parameters, as well as duration of hospital and intensive care unit stay, graft survival, patient survival, and biliary complications served as secondary endpoints. Results: Between April 2015 and August 2019, we randomized 177 livers, resulting in 170 liver transplantations (85 in the HOPE group and 85 in the control group). The number of patients with at least one Clavien ≥III complication was 46/85 (54.1%) in the control group and 44/85 (51.8%) in the HOPE group (odds ratio 0.91; 95% CI 0.50-1.66; p = 0.76). Secondary endpoints were also not significantly different between groups. A post hoc analysis revealed that liver-related Clavien ≥IIIb complications occurred less frequently in the HOPE group compared to the control group (risk ratio 0.26; 95% CI 0.07-0.77; p = 0.027). Likewise, graft failure due to liver-related complications did not occur in the HOPE group, but occurred in 7% (6 of 85) of the control group (log-rank test, p = 0.004, Gray test, p = 0.015). Conclusions: HOPE after cold storage of DBD livers resulted in similar proportions of patients with at least one Clavien ≥III complication compared to controls. Exploratory findings suggest that HOPE decreases the risk of severe liver graft-related events. Impact and implications: This randomized controlled phase III trial is the first to investigate the impact of hypothermic oxygenated perfusion (HOPE) on cumulative complications within a 12-month period after liver transplantation. Compared to conventional cold storage, HOPE did not have a significant effect on the number of patients with at least one Clavien ≥III complication. However, we believe that HOPE may have a beneficial effect on the quantity of complications per patient, based on its application leading to fewer severe liver graft-related complications, and to a lower risk of liver-related graft loss. The HOPE approach can be applied easily after organ transport during recipient hepatectomy. This appears fundamental for wide acceptance since concurring perfusion technologies need either perfusion at donor sites or continuous perfusion during organ transport, which are much costlier and more laborious. We conclude therefore that the post hoc findings of this trial should be further validated in future studies.</p

    A multicenter randomized-controlled trial of hypothermic oxygenated perfusion (HOPE) for human liver grafts before transplantation

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    Background &amp; Aims: Machine perfusion is a novel method intended to optimize livers before transplantation. However, its effect on morbidity within a 1-year period after transplantation has remained unclear. Methods: In this multicenter controlled trial, we randomly assigned livers donated after brain death (DBD) for liver transplantation (LT). Livers were either conventionally cold stored (control group), or cold stored and subsequently treated by 1-2 h hypothermic oxygenated perfusion (HOPE) before implantation (HOPE group). The primary endpoint was the occurrence of at least one post-transplant complication per patient, graded by the Clavien score of ≥III, within 1-year after LT. The comprehensive complication index (CCI), laboratory parameters, as well as duration of hospital and intensive care unit stay, graft survival, patient survival, and biliary complications served as secondary endpoints. Results: Between April 2015 and August 2019, we randomized 177 livers, resulting in 170 liver transplantations (85 in the HOPE group and 85 in the control group). The number of patients with at least one Clavien ≥III complication was 46/85 (54.1%) in the control group and 44/85 (51.8%) in the HOPE group (odds ratio 0.91; 95% CI 0.50-1.66; p = 0.76). Secondary endpoints were also not significantly different between groups. A post hoc analysis revealed that liver-related Clavien ≥IIIb complications occurred less frequently in the HOPE group compared to the control group (risk ratio 0.26; 95% CI 0.07-0.77; p = 0.027). Likewise, graft failure due to liver-related complications did not occur in the HOPE group, but occurred in 7% (6 of 85) of the control group (log-rank test, p = 0.004, Gray test, p = 0.015). Conclusions: HOPE after cold storage of DBD livers resulted in similar proportions of patients with at least one Clavien ≥III complication compared to controls. Exploratory findings suggest that HOPE decreases the risk of severe liver graft-related events. Impact and implications: This randomized controlled phase III trial is the first to investigate the impact of hypothermic oxygenated perfusion (HOPE) on cumulative complications within a 12-month period after liver transplantation. Compared to conventional cold storage, HOPE did not have a significant effect on the number of patients with at least one Clavien ≥III complication. However, we believe that HOPE may have a beneficial effect on the quantity of complications per patient, based on its application leading to fewer severe liver graft-related complications, and to a lower risk of liver-related graft loss. The HOPE approach can be applied easily after organ transport during recipient hepatectomy. This appears fundamental for wide acceptance since concurring perfusion technologies need either perfusion at donor sites or continuous perfusion during organ transport, which are much costlier and more laborious. We conclude therefore that the post hoc findings of this trial should be further validated in future studies.</p

    Outcomes After Distal Pancreatectomy with Celiac Axis Resection for Pancreatic Cancer: A Pan-European Retrospective Cohort Study

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    BACKGROUND: Western multicenter studies on distal pancreatectomy with celiac axis resection (DP-CAR), also known as the Appleby procedure, for locally advanced pancreatic cancer are lacking. We aimed to study overall survival, morbidity, mortality and the impact of preoperative hepatic artery embolization (PHAE). METHODS: Retrospective cohort study within the European-African Hepato-Pancreato-Biliary-Association, on DP-CAR between 1-1-2000 and 6-1-2016. Primary endpoint was overall survival. Secondary endpoints were radicality (R0-resection), 90-day mortality, major morbidity, and pancreatic fistulae (grade B/C). RESULTS: We included 68 patients from 20 hospitals in 12 countries. Postoperatively, 53% of patients had R0-resection, 25% major morbidity, 21% an ISGPS grade B/C pancreatic fistula, and 16% mortality. In total, 82% received (neo-)adjuvant chemotherapy and median overall survival in 62 patients with pancreatic ductal adenocarcinoma patients was 18 months (CI 10-37). We observed no impact of PHAE on ischemic complications. CONCLUSIONS: DP-CAR combined with chemotherapy for locally advanced pancreatic cancer is associated with acceptable overall survival. The 90-day mortality is too high and should be reduced. Future studies should investigate to what extent increasing surgical volume or better patient selection can improve outcomes

    Complications de l'hypertension portale en transplantation hépatique (évolution des concepts sur la gestion du système porte)

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    L'hypertension portale (HTP) peut être responsable de complications vasculaires et hémodynamiques dans le territoire splénique [splénomégalie, hypersplénisme, anévrysme de l'artère splénique, syndrome de l'artère splénique, shunt spléno-rénal (SSR)] qui peuvent justifier une prise en charge spécifique au cdurs d'une transplantation hépatique (TH). Le but de ce travail était (i) d'évaluer différentes stratégies de déconnexion des SSR [splénectomie (SP), ligature de la veine rénale gauche (LVR) et anastomose réno porte (ARP)] permettant d'assurer une revascularisation porte optimale du greffon hépatique au cours d'une TH et (ii) d'évaluer les résultats de la splénectomie (quelle que soit son indication) en TH. Deux séries rétrospectives sont rapportées: 1/ De 1994 à 2012, 48 SP (dont 22 pour SSR) et 7 LVR pour SSR ont été réalisées à la Croix-Rousse (Lyon). Les données peropératoires d'un groupe de 709 patients transplantés mais sans SP pendant la même période étaient comparées au groupe avec SP (n=48). Les résultats postopératoires (TH avec SP) étaient comparés aux données de la littérature (TH sans SP) ; 2/ De 1998 à 2012, 15 LVR et 17 ARP pour SSR ont été réalisées à Paul Brousse (Paris). La SP, la LVR et l'ARP étaient d'efficacité comparable pour la déconnexion des SSR. Après SP, LVR et ARP, la survie à 3 mois et à 5 ans était respectivement de 96%, 91% et 100o/o et de 83%, 60% et 79% (p=0,01). Les groupes ARP et LVR étaient comparables sauf pour le taux de thrombose porte préopératoire supérieur dans le groupe ARP (76% vs 27%). Les survies étaient identiques (p=0,1) mais le risque d'insuffisance rénale temporaire post TH était plus important après ARP qu'après LVR. En cas d'HTP modérée, la survie était meilleure après ARP qu'après LVR (p=0,049). Chez les patients splénectomisés au cours de la TH, et par rapport aux patients transplantés sans SP, (i) le taux transfusionnel (+3 PGR), la durée opératoire (+53 minutes) et la survenue d'une thrombose porte postopératoire (35%) étaient plus importants, (ii) la thrombopénie était corrigée significativement plus rapidement, le taux de rejet était moins important alors que le taux d'infections (précoces ou tardives) étaient comparable. La déconnexion des shunts spléno-rénaux associée à la prise en charge d'une éventuelle thrombose porte permet d'obtenir des survies comparables à celle des patients transplantés sans SSR. La SP traite efficacement toutes les complications spléniques de l'HTP et, pour les SSR, reste une alternative possible à l'ARP et à la LVR malgré une morbidité péri-opératoire plus importante. La réalisation d'une LVR est à discuter uniquement en présence d'une HTP sévère alors que l'ARP permet une excellente survie quel que soit le degré d'HTP et la perméabilité de la veine porte avant la THLYON1-BU Santé (693882101) / SudocSudocFranceF

    Le reflux duodéno-gastro-oesophagien (données actuelles, apport de la détection de bilirubine par spectrophotométrie)

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    L'objectif de ce travail a été de faire le point sur les connaissances actuelles concernant les mécanismes physiopathologiques, les moyens diagnostiques et thérapeutiques du reflux duodéno-gastro-oesophagien et de rapporter nos travaux de recherche et d'évaluation clinique concernant cette entité pathologique. La première partie est consacrée au reflux duodéno-gastrique primaire et à la méthode de détection de la bilirubine par spectrophotométrie. Nous rapportons notre expérience acquise dans l'unité de chirurgie oeso-gastrique du Pr Collard à l'Université Catholique de Louvain (Cliniques Universitaires Saint-Luc) à Bruxelles. La deuxième partie est consacrée au reflux biliaire secondaire en cas de pathologie biliaire ou après chirurgie oeso-gastro-duodénale. Nous rapportons notre expérience concernant le reflux biliaire postopératoire en fonction de différents types de montages chirurgicaux après chirurgie gastrique. La troisième partie est consacrée aux lésions d'endobrachyoesophage. Le rôle du reflux biliaire dans la genèse et la transformation des lésions d'endobrachyoesophage est précisé ainsi que l'impact des différents montages chirurgicaux anti-reflux sur les lésions d'endobrachyoesophage. Nous détaillons également un projet de recherche expérimentale débuté chez l'animal à la recherche de marqueurs diagnostiques précoces (p63, Cox-2) de dégénérescence de la muqueuse d'endobrachyoesophage en adénocarcinome de l'œsophageLYON1-BU.Sciences (692662101) / SudocSudocFranceF
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