Pouya Iranmanesh1, Jean-Louis Frossard2, Béatrice Mugnier-Konrad3, Philippe Morel1, Pietro Majno1, Thai Nguyen-Tang2, Thierry Berney1, Gilles Mentha1, Christian Toso1. 1. Division of Digestive Surgery, Department of Surgery, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland2Division of Transplant Surgery, Department of Surgery, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland3He. 2. Hepato-Pancreato-Biliary Centre, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland4Division of Gastroenterology and Hepatology, Department of Medical Specialties, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerlan. 3. Division of Digestive Surgery, Department of Surgery, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland2Division of Transplant Surgery, Department of Surgery, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland.
Abstract
IMPORTANCE: The optimal management of treatment for patients at intermediate risk of a common duct stone (including increased liver function tests but bilirubin <4 mg/dL and no cholangitis) is a matter of debate. Many stones migrate spontaneously into the duodenum, making preoperative common duct investigations unnecessary. OBJECTIVE: To compare strategies of cholecystectomy first vs a sequential endoscopic common duct assessment and cholecystectomy for the management of patients with an intermediate risk of a common duct stone. The main objective was to reduce the length of stay and the secondary objectives were to reduce the number of common duct investigations, morbidity, and costs. DESIGN, SETTING, AND PARTICIPANTS: Interventional, randomized clinical trial with 2 parallel groups performed between June 2011 and February 2013, with a patient follow-up of 6 months. The trial comprised a random sample of 100 adult patients admitted to Geneva University Hospital, Geneva, Switzerland, for acute gallstone-related conditions with an intermediate risk of a common duct stone. Fifty patients were randomized to each group. INTERVENTIONS: Cholecystectomy first with intraoperative cholangiogram for the study group and endoscopic common duct assessment and clearance followed by cholecystectomy for the control group. MAIN OUTCOMES AND MEASURES: Length of initial hospital stay (primary end point), number of common duct investigations and morbidity and mortality within 6 months after initial admission, and quality of life at 1 and 6 months after discharge (EQ-5D-5L [EuroQol Group, 5-level] questionnaire). RESULTS: Patients who underwent cholecystectomy as a first step had a significantly shorter length of hospital stay (median, 5 days [interquartile range {IQR}, 1-8] vs median, 8 days [IQR, 6-12]; P < .001), with fewer common duct investigations (25 vs 71; P < .001), no significant difference in morbidity or quality of life. CONCLUSIONS AND RELEVANCE: Among patients at intermediate risk of a common duct stone, initial cholecystectomy compared with sequential common duct endoscopy assessment and subsequent surgery resulted in a shorter length of stay without increased morbidity. If these findings are confirmed, initial cholecystectomy with intraoperative cholangiogram may be a preferred approach. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01492790.
RCT Entities:
IMPORTANCE: The optimal management of treatment for patients at intermediate risk of a common duct stone (including increased liver function tests but bilirubin <4 mg/dL and no cholangitis) is a matter of debate. Many stones migrate spontaneously into the duodenum, making preoperative common duct investigations unnecessary. OBJECTIVE: To compare strategies of cholecystectomy first vs a sequential endoscopic common duct assessment and cholecystectomy for the management of patients with an intermediate risk of a common duct stone. The main objective was to reduce the length of stay and the secondary objectives were to reduce the number of common duct investigations, morbidity, and costs. DESIGN, SETTING, AND PARTICIPANTS: Interventional, randomized clinical trial with 2 parallel groups performed between June 2011 and February 2013, with a patient follow-up of 6 months. The trial comprised a random sample of 100 adult patients admitted to Geneva University Hospital, Geneva, Switzerland, for acute gallstone-related conditions with an intermediate risk of a common duct stone. Fifty patients were randomized to each group. INTERVENTIONS: Cholecystectomy first with intraoperative cholangiogram for the study group and endoscopic common duct assessment and clearance followed by cholecystectomy for the control group. MAIN OUTCOMES AND MEASURES: Length of initial hospital stay (primary end point), number of common duct investigations and morbidity and mortality within 6 months after initial admission, and quality of life at 1 and 6 months after discharge (EQ-5D-5L [EuroQol Group, 5-level] questionnaire). RESULTS:Patients who underwent cholecystectomy as a first step had a significantly shorter length of hospital stay (median, 5 days [interquartile range {IQR}, 1-8] vs median, 8 days [IQR, 6-12]; P < .001), with fewer common duct investigations (25 vs 71; P < .001), no significant difference in morbidity or quality of life. CONCLUSIONS AND RELEVANCE: Among patients at intermediate risk of a common duct stone, initial cholecystectomy compared with sequential common duct endoscopy assessment and subsequent surgery resulted in a shorter length of stay without increased morbidity. If these findings are confirmed, initial cholecystectomy with intraoperative cholangiogram may be a preferred approach. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01492790.
Authors: Rebeccah B Baucom; Irene D Feurer; Julia S Shelton; Kristy Kummerow; Michael D Holzman; Benjamin K Poulose Journal: Surg Endosc Date: 2015-06-20 Impact factor: 4.584
Authors: Alice M Couwenberg; Maarten J P Burbach; Anke B Smits; Marco Van Vulpen; Wilhemina M U Van Grevenstein; Peter G Noordzij; Helena M Verkooijen Journal: Trials Date: 2016-03-10 Impact factor: 2.279
Authors: Pouya Iranmanesh; Olivier Tobler; Sandra De Sousa; Axel Andres; Jean-Louis Frossard; Philippe Morel; Christian Toso Journal: PLoS One Date: 2018-06-28 Impact factor: 3.240