The Cholegas Study

Safety of prophylactic cholecystectomy during gastrectomy for cancer: Preliminary results of a multicentric randomized clinical trial

Marco Bernini, Lapo Bencini, Riccardo Sacchetti, Alberto Marchet, Luigi Cristadoro, Fabio Pacelli, Stefano Berardi, Giovanni B. Doglietto, Fausto Rosa, Giuseppe Verlato, Luca Cozzaglio, Paolo Bechi, Daniele Marrelli, Franco Roviello, Marco Farsi

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Background: Cholelithiasis is more frequent in patients after gastrectomy, due to dissection of vagal branches and gastrointestinal reconstruction. Methods: A randomized controlled trial was conducted from November 2008 to March 2012. Patients were randomized into two groups: prophylactic cholecystectomy (PC) and standard gastric surgery only (SS) for curable cancers. We planned three end points: evaluation of the number of patients who developed symptoms and needed further surgery for cholelithiasis after standard gastric cancer surgery, evaluation of the incidence of cholelithiasis overall after standard gastric cancer surgery and perioperative complications or costs of prophylactic cholecystectomy. The present study answers to the last end point only. Results: After 40 months from the beginning of study, 172 patients were eligible from 9 Centers. Ten patients refused consent and 32 were excluded due to flawing of inclusion criteria (not confirmed adenocarcinomas and no R0 surgery). Therefore, final analysis included 130 patients: 65 in PC group and 65 in SS. Among PC group, 12 patients had surgical complications during the perioperative period; only 1 biliary leakage, conservatively treated, might have been caused by prophylactic cholecystectomy. 6 patients had surgical complications in SS group. One postoperative death occurred in PC group due to pulmonary embolism. Differences were not statistically significant. Similarly, no differences were significant in duration of surgery, blood loss, hospital stay. Conclusions: Concomitant cholecystectomy during standard surgery for gastric malignancies seemed to add no extra perioperative morbidity, mortality and costs to the sample included in the study.

Original languageEnglish
Pages (from-to)370-376
Number of pages7
JournalGastric Cancer
Volume16
Issue number3
DOIs
Publication statusPublished - Jul 2013

Fingerprint

Cholecystectomy
Gastrectomy
Randomized Controlled Trials
Safety
Cholelithiasis
Neoplasms
Stomach Neoplasms
Stomach
Costs and Cost Analysis
Perioperative Period
Pulmonary Embolism
Dissection
Length of Stay
Adenocarcinoma
Morbidity
Mortality
Incidence

Keywords

  • Gastric cancer surgery
  • Prophylactic cholecystectomy
  • Randomized trial

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology
  • Cancer Research

Cite this

The Cholegas Study : Safety of prophylactic cholecystectomy during gastrectomy for cancer: Preliminary results of a multicentric randomized clinical trial. / Bernini, Marco; Bencini, Lapo; Sacchetti, Riccardo; Marchet, Alberto; Cristadoro, Luigi; Pacelli, Fabio; Berardi, Stefano; Doglietto, Giovanni B.; Rosa, Fausto; Verlato, Giuseppe; Cozzaglio, Luca; Bechi, Paolo; Marrelli, Daniele; Roviello, Franco; Farsi, Marco.

In: Gastric Cancer, Vol. 16, No. 3, 07.2013, p. 370-376.

Research output: Contribution to journalArticle

Bernini, M, Bencini, L, Sacchetti, R, Marchet, A, Cristadoro, L, Pacelli, F, Berardi, S, Doglietto, GB, Rosa, F, Verlato, G, Cozzaglio, L, Bechi, P, Marrelli, D, Roviello, F & Farsi, M 2013, 'The Cholegas Study: Safety of prophylactic cholecystectomy during gastrectomy for cancer: Preliminary results of a multicentric randomized clinical trial', Gastric Cancer, vol. 16, no. 3, pp. 370-376. https://doi.org/10.1007/s10120-012-0195-9
Bernini, Marco ; Bencini, Lapo ; Sacchetti, Riccardo ; Marchet, Alberto ; Cristadoro, Luigi ; Pacelli, Fabio ; Berardi, Stefano ; Doglietto, Giovanni B. ; Rosa, Fausto ; Verlato, Giuseppe ; Cozzaglio, Luca ; Bechi, Paolo ; Marrelli, Daniele ; Roviello, Franco ; Farsi, Marco. / The Cholegas Study : Safety of prophylactic cholecystectomy during gastrectomy for cancer: Preliminary results of a multicentric randomized clinical trial. In: Gastric Cancer. 2013 ; Vol. 16, No. 3. pp. 370-376.
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AU - Marchet, Alberto

AU - Cristadoro, Luigi

AU - Pacelli, Fabio

AU - Berardi, Stefano

AU - Doglietto, Giovanni B.

AU - Rosa, Fausto

AU - Verlato, Giuseppe

AU - Cozzaglio, Luca

AU - Bechi, Paolo

AU - Marrelli, Daniele

AU - Roviello, Franco

AU - Farsi, Marco

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N2 - Background: Cholelithiasis is more frequent in patients after gastrectomy, due to dissection of vagal branches and gastrointestinal reconstruction. Methods: A randomized controlled trial was conducted from November 2008 to March 2012. Patients were randomized into two groups: prophylactic cholecystectomy (PC) and standard gastric surgery only (SS) for curable cancers. We planned three end points: evaluation of the number of patients who developed symptoms and needed further surgery for cholelithiasis after standard gastric cancer surgery, evaluation of the incidence of cholelithiasis overall after standard gastric cancer surgery and perioperative complications or costs of prophylactic cholecystectomy. The present study answers to the last end point only. Results: After 40 months from the beginning of study, 172 patients were eligible from 9 Centers. Ten patients refused consent and 32 were excluded due to flawing of inclusion criteria (not confirmed adenocarcinomas and no R0 surgery). Therefore, final analysis included 130 patients: 65 in PC group and 65 in SS. Among PC group, 12 patients had surgical complications during the perioperative period; only 1 biliary leakage, conservatively treated, might have been caused by prophylactic cholecystectomy. 6 patients had surgical complications in SS group. One postoperative death occurred in PC group due to pulmonary embolism. Differences were not statistically significant. Similarly, no differences were significant in duration of surgery, blood loss, hospital stay. Conclusions: Concomitant cholecystectomy during standard surgery for gastric malignancies seemed to add no extra perioperative morbidity, mortality and costs to the sample included in the study.

AB - Background: Cholelithiasis is more frequent in patients after gastrectomy, due to dissection of vagal branches and gastrointestinal reconstruction. Methods: A randomized controlled trial was conducted from November 2008 to March 2012. Patients were randomized into two groups: prophylactic cholecystectomy (PC) and standard gastric surgery only (SS) for curable cancers. We planned three end points: evaluation of the number of patients who developed symptoms and needed further surgery for cholelithiasis after standard gastric cancer surgery, evaluation of the incidence of cholelithiasis overall after standard gastric cancer surgery and perioperative complications or costs of prophylactic cholecystectomy. The present study answers to the last end point only. Results: After 40 months from the beginning of study, 172 patients were eligible from 9 Centers. Ten patients refused consent and 32 were excluded due to flawing of inclusion criteria (not confirmed adenocarcinomas and no R0 surgery). Therefore, final analysis included 130 patients: 65 in PC group and 65 in SS. Among PC group, 12 patients had surgical complications during the perioperative period; only 1 biliary leakage, conservatively treated, might have been caused by prophylactic cholecystectomy. 6 patients had surgical complications in SS group. One postoperative death occurred in PC group due to pulmonary embolism. Differences were not statistically significant. Similarly, no differences were significant in duration of surgery, blood loss, hospital stay. Conclusions: Concomitant cholecystectomy during standard surgery for gastric malignancies seemed to add no extra perioperative morbidity, mortality and costs to the sample included in the study.

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