The Cholegas trial: long-term results of prophylactic cholecystectomy during gastrectomy for cancer—a randomized-controlled trial

Italian Research Group for Gastric Cancer (GIRCG)

Research output: Contribution to journalArticle

Abstract

Background: The incidence of cholelithiasis has been shown to be higher for patients after gastrectomy than for the general population, due to vagal branch damage and gastrointestinal reconstruction. The aim of this trial was to evaluate the need for routine concomitant prophylactic cholecystectomy (PC) during gastrectomy for cancer. Methods: A multicenter, randomized, controlled trial was conducted between November 2008 and March 2017. Of the total 130 included patients, 65 underwent PC and 65 underwent standard gastric surgery only for curable cancers. The primary endpoint was cholelithiasis-free survival after gastrectomy for gastric adenocarcinoma. Cholelithiasis was detected by ultrasound exam. Results: After a median follow-up of 62 months, eight patients (12.3%) in the control group developed biliary abnormalities (four cases of gallbladder calculi and four cases of biliary sludge), with only three (4.6%) being clinically relevant (two cholecystectomies needed, one acute pancreatitis). One patient in the PC group had asymptomatic biliary dilatation during sonography after surgery. The cholelithiasis-free survival did not show statistical significance between the two groups (P = 0.267). The number needed to treat with PC to avoid reoperation for cholelithiasis was 1:32.5. Conclusions: Concomitant PC during gastric surgery for malignancies, although reducing the absolute number of biliary abnormalities, has no significant impact on the natural course of patients.

Original languageEnglish
JournalGastric Cancer
DOIs
Publication statusAccepted/In press - Jan 1 2018

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Cholecystectomy
Gastrectomy
Cholelithiasis
Randomized Controlled Trials
Stomach
Numbers Needed To Treat
Neoplasms
Survival
Calculi
Gallbladder
Reoperation
Bile
Pancreatitis
Dilatation
Ultrasonography
Adenocarcinoma
Control Groups
Incidence
Population

Keywords

  • Gastric cancer
  • Gastric surgery
  • Prophylactic cholecystectomy

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology
  • Cancer Research

Cite this

The Cholegas trial : long-term results of prophylactic cholecystectomy during gastrectomy for cancer—a randomized-controlled trial. / Italian Research Group for Gastric Cancer (GIRCG).

In: Gastric Cancer, 01.01.2018.

Research output: Contribution to journalArticle

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abstract = "Background: The incidence of cholelithiasis has been shown to be higher for patients after gastrectomy than for the general population, due to vagal branch damage and gastrointestinal reconstruction. The aim of this trial was to evaluate the need for routine concomitant prophylactic cholecystectomy (PC) during gastrectomy for cancer. Methods: A multicenter, randomized, controlled trial was conducted between November 2008 and March 2017. Of the total 130 included patients, 65 underwent PC and 65 underwent standard gastric surgery only for curable cancers. The primary endpoint was cholelithiasis-free survival after gastrectomy for gastric adenocarcinoma. Cholelithiasis was detected by ultrasound exam. Results: After a median follow-up of 62 months, eight patients (12.3{\%}) in the control group developed biliary abnormalities (four cases of gallbladder calculi and four cases of biliary sludge), with only three (4.6{\%}) being clinically relevant (two cholecystectomies needed, one acute pancreatitis). One patient in the PC group had asymptomatic biliary dilatation during sonography after surgery. The cholelithiasis-free survival did not show statistical significance between the two groups (P = 0.267). The number needed to treat with PC to avoid reoperation for cholelithiasis was 1:32.5. Conclusions: Concomitant PC during gastric surgery for malignancies, although reducing the absolute number of biliary abnormalities, has no significant impact on the natural course of patients.",
keywords = "Gastric cancer, Gastric surgery, Prophylactic cholecystectomy",
author = "{Italian Research Group for Gastric Cancer (GIRCG)} and Lapo Bencini and Alberto Marchet and Sergio Alfieri and Fausto Rosa and Giuseppe Verlato and Daniele Marrelli and Franco Roviello and Fabio Pacelli and Luigi Cristadoro and Antonio Taddei and Marco Farsi and Marco Bernini and Leonardo Gerard and Renato Moretti and Luca Cozzaglio and Stefano Berardi and Paolo Bechi",
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T2 - long-term results of prophylactic cholecystectomy during gastrectomy for cancer—a randomized-controlled trial

AU - Italian Research Group for Gastric Cancer (GIRCG)

AU - Bencini, Lapo

AU - Marchet, Alberto

AU - Alfieri, Sergio

AU - Rosa, Fausto

AU - Verlato, Giuseppe

AU - Marrelli, Daniele

AU - Roviello, Franco

AU - Pacelli, Fabio

AU - Cristadoro, Luigi

AU - Taddei, Antonio

AU - Farsi, Marco

AU - Bernini, Marco

AU - Gerard, Leonardo

AU - Moretti, Renato

AU - Cozzaglio, Luca

AU - Berardi, Stefano

AU - Bechi, Paolo

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: The incidence of cholelithiasis has been shown to be higher for patients after gastrectomy than for the general population, due to vagal branch damage and gastrointestinal reconstruction. The aim of this trial was to evaluate the need for routine concomitant prophylactic cholecystectomy (PC) during gastrectomy for cancer. Methods: A multicenter, randomized, controlled trial was conducted between November 2008 and March 2017. Of the total 130 included patients, 65 underwent PC and 65 underwent standard gastric surgery only for curable cancers. The primary endpoint was cholelithiasis-free survival after gastrectomy for gastric adenocarcinoma. Cholelithiasis was detected by ultrasound exam. Results: After a median follow-up of 62 months, eight patients (12.3%) in the control group developed biliary abnormalities (four cases of gallbladder calculi and four cases of biliary sludge), with only three (4.6%) being clinically relevant (two cholecystectomies needed, one acute pancreatitis). One patient in the PC group had asymptomatic biliary dilatation during sonography after surgery. The cholelithiasis-free survival did not show statistical significance between the two groups (P = 0.267). The number needed to treat with PC to avoid reoperation for cholelithiasis was 1:32.5. Conclusions: Concomitant PC during gastric surgery for malignancies, although reducing the absolute number of biliary abnormalities, has no significant impact on the natural course of patients.

AB - Background: The incidence of cholelithiasis has been shown to be higher for patients after gastrectomy than for the general population, due to vagal branch damage and gastrointestinal reconstruction. The aim of this trial was to evaluate the need for routine concomitant prophylactic cholecystectomy (PC) during gastrectomy for cancer. Methods: A multicenter, randomized, controlled trial was conducted between November 2008 and March 2017. Of the total 130 included patients, 65 underwent PC and 65 underwent standard gastric surgery only for curable cancers. The primary endpoint was cholelithiasis-free survival after gastrectomy for gastric adenocarcinoma. Cholelithiasis was detected by ultrasound exam. Results: After a median follow-up of 62 months, eight patients (12.3%) in the control group developed biliary abnormalities (four cases of gallbladder calculi and four cases of biliary sludge), with only three (4.6%) being clinically relevant (two cholecystectomies needed, one acute pancreatitis). One patient in the PC group had asymptomatic biliary dilatation during sonography after surgery. The cholelithiasis-free survival did not show statistical significance between the two groups (P = 0.267). The number needed to treat with PC to avoid reoperation for cholelithiasis was 1:32.5. Conclusions: Concomitant PC during gastric surgery for malignancies, although reducing the absolute number of biliary abnormalities, has no significant impact on the natural course of patients.

KW - Gastric cancer

KW - Gastric surgery

KW - Prophylactic cholecystectomy

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SN - 1436-3291

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