Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer, surgery, prophylactic cholecystectomy
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: cholecystectomy
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients undergoing standard gastric surgery for cancer

Exclusion Criteria:

- gallbladder disease
Location
Azienda Ospedaliero-Universitaria Careggi - Chirurgia Generale ed Oncologica
Florence, Italy
Status: Recruiting
Contact: Lapo Bencini, MD - lapbenc@tin.it
Start Date
September 2008
Completion Date
September 2015
Sponsors
Italian Research Group for Gastric Cancer
Source
Italian Research Group for Gastric Cancer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page