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 language | English |
|---|---|
| Pages (from-to) | 370-376 |
| Number of pages | 7 |
| Journal | Gastric Cancer |
| Volume | 16 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Jul 2013 |
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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 journal › Article
}
TY - JOUR
T1 - The Cholegas Study
T2 - Safety of prophylactic cholecystectomy during gastrectomy for cancer: Preliminary results of a multicentric randomized clinical trial
AU - Bernini, Marco
AU - Bencini, Lapo
AU - Sacchetti, Riccardo
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
PY - 2013/7
Y1 - 2013/7
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.
KW - Gastric cancer surgery
KW - Prophylactic cholecystectomy
KW - Randomized trial
UR - http://www.scopus.com/inward/record.url?scp=84880835380&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84880835380&partnerID=8YFLogxK
U2 - 10.1007/s10120-012-0195-9
DO - 10.1007/s10120-012-0195-9
M3 - Article
C2 - 22948317
AN - SCOPUS:84880835380
VL - 16
SP - 370
EP - 376
JO - Gastric Cancer
JF - Gastric Cancer
SN - 1436-3291
IS - 3
ER -