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Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00757640
Acronym
CHOLEGAS
Enrollment
150
Registered
2008-09-23
Start date
2008-09-30
Completion date
2015-09-30
Last updated
2021-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

gastric cancer, surgery, prophylactic cholecystectomy

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.

Interventions

PROCEDUREcholecystectomy

prophylactic cholecystectomy during standard gastric surgery for cancer

Sponsors

Azienda Ospedaliero-Universitaria Careggi
CollaboratorOTHER
Italian Research Group for Gastric Cancer
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing standard gastric surgery for cancer

Exclusion criteria

* gallbladder disease

Design outcomes

Primary

MeasureTime frame
Reduced biliary complications5 years

Secondary

MeasureTime frame
Improved quality of life5 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026