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
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Procedure: cholecystectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Italian Research Group for Gastric Cancer:

Primary Outcome Measures:
  • Reduced biliary complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improved quality of life [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: September 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: B
no cholecystectomy
Experimental: A
cholecystectomy
Procedure: cholecystectomy
prophylactic cholecystectomy during standard gastric surgery for cancer
Other Name: cholecystectomy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing standard gastric surgery for cancer

Exclusion Criteria:

  • gallbladder disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757640

Contacts
Contact: Marco Farsi, MD 0039-055-7947240 marcofarsi@tin.it
Contact: Lapo Bencini, MD lapbenc@tin.it

Locations
Italy
Azienda Ospedaliero-Universitaria Careggi - Chirurgia Generale ed Oncologica Recruiting
Florence, Italy, 50134
Contact: Lapo Bencini, MD       lapbenc@tin.it   
Sub-Investigator: Lapo Bencini, MD         
Sponsors and Collaborators
Italian Research Group for Gastric Cancer
Azienda Ospedaliero-Universitaria Careggi
Investigators
Principal Investigator: Marco Farsi, MD Chirurgia Generale e Oncologica Azienda Ospedaliero-Universitaria Careggi
  More Information

Additional Information:
No publications provided by Italian Research Group for Gastric Cancer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Farsi, Chirurgia Generale e Oncologica Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT00757640     History of Changes
Other Study ID Numbers: Firenze 1
Study First Received: September 20, 2008
Last Updated: September 20, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by Italian Research Group for Gastric Cancer:
gastric cancer, surgery, prophylactic cholecystectomy

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on October 28, 2014