Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery (CHOLEGAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2008 by Italian Research Group for Gastric Cancer
Sponsor:
Collaborator:
Azienda Ospedaliero-Universitaria Careggi
Information provided by:
Italian Research Group for Gastric Cancer
ClinicalTrials.gov Identifier:
NCT00757640
First received: September 20, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 20, 2008
September 20, 2008
September 2008
September 2010   (final data collection date for primary outcome measure)
Reduced biliary complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Improved quality of life [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastric Cancer
Procedure: cholecystectomy
prophylactic cholecystectomy during standard gastric surgery for cancer
Other Name: cholecystectomy
  • No Intervention: B
    no cholecystectomy
  • Experimental: A
    cholecystectomy
    Intervention: Procedure: cholecystectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
September 2015
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing standard gastric surgery for cancer

Exclusion Criteria:

  • gallbladder disease
Both
18 Years to 80 Years
No
Contact: Marco Farsi, MD 0039-055-7947240 marcofarsi@tin.it
Contact: Lapo Bencini, MD lapbenc@tin.it
Italy
 
NCT00757640
Firenze 1
No
Marco Farsi, Chirurgia Generale e Oncologica Azienda Ospedaliero-Universitaria Careggi
Italian Research Group for Gastric Cancer
Azienda Ospedaliero-Universitaria Careggi
Principal Investigator: Marco Farsi, MD Chirurgia Generale e Oncologica Azienda Ospedaliero-Universitaria Careggi
Italian Research Group for Gastric Cancer
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP