Back to resultsGastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery (CHOLEGAS)
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, surgery, prophylactic cholecystectomy
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing standard gastric surgery for cancer
Exclusion Criteria:
- gallbladder disease
Sites / Locations
- Azienda Ospedaliero-Universitaria Careggi - Chirurgia Generale ed Oncologica
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
B
A
Arm Description
no cholecystectomy
cholecystectomy
Outcomes
Primary Outcome Measures
Reduced biliary complications
Secondary Outcome Measures
Improved quality of life
Full Information
NCT ID
NCT00757640
First Posted
September 20, 2008
Last Updated
February 10, 2021
Sponsor
Italian Research Group for Gastric Cancer
Collaborators
Azienda Ospedaliero-Universitaria Careggi
1. Study Identification
Unique Protocol Identification Number
NCT00757640
Brief Title
Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery
Acronym
CHOLEGAS
Official Title
The CHOLEGAS Study: Multicentric Randomized, Double-blinded, Controlled Trial of Gastrectomy Plus Prophylactic Cholecystectomy Versus Gastrectomy Only, in Adults Submitted to Gastric Cancer Surgery With Curative Intent.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Italian Research Group for Gastric Cancer
Collaborators
Azienda Ospedaliero-Universitaria Careggi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The patients will be divided into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group will be submitted to standard gastric surgery only.
Detailed Description
The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, surgery, prophylactic cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B
Arm Type
No Intervention
Arm Description
no cholecystectomy
Arm Title
A
Arm Type
Experimental
Arm Description
cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
cholecystectomy
Intervention Description
prophylactic cholecystectomy during standard gastric surgery for cancer
Primary Outcome Measure Information:
Title
Reduced biliary complications
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Improved quality of life
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing standard gastric surgery for cancer
Exclusion Criteria:
gallbladder disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Farsi, MD
Organizational Affiliation
Chirurgia Generale e Oncologica Azienda Ospedaliero-Universitaria Careggi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria Careggi - Chirurgia Generale ed Oncologica
City
Florence
ZIP/Postal Code
50134
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22948317
Citation
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; Italian Research Group for Gastric Cancer (IRGGC). The Cholegas Study: safety of prophylactic cholecystectomy during gastrectomy for cancer: preliminary results of a multicentric randomized clinical trial. Gastric Cancer. 2013 Jul;16(3):370-6. doi: 10.1007/s10120-012-0195-9. Epub 2012 Sep 5.
Results Reference
derived
PubMed Identifier
19445661
Citation
Farsi M, Bernini M, Bencini L, Miranda E, Manetti R, de Manzoni G, Verlato G, Marrelli D, Pedrazzani C, Roviello F, Marchet A, Cristadoro L, Gerard L, Moretti R; GIRCG (Gruppo Italiano di Ricerca sul Cancro Gastrico). The CHOLEGAS study: multicentric randomized, blinded, controlled trial of gastrectomy plus prophylactic cholecystectomy versus gastrectomy only, in adults submitted to gastric cancer surgery with curative intent. Trials. 2009 May 15;10:32. doi: 10.1186/1745-6215-10-32.
Results Reference
derived
Links:
URL
http://www.gircg.it/
Description
official site of group study
Learn more about this trial
Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery
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