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Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery (CHOLEGAS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by Italian Research Group for Gastric Cancer.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00757640
First Posted: September 23, 2008
Last Update Posted: September 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Azienda Ospedaliero-Universitaria Careggi
Information provided by:
Italian Research Group for Gastric Cancer
  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
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, 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 ]

Secondary Outcome Measures:
  • Improved quality of life [ Time Frame: 5 years ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing standard gastric surgery for cancer

Exclusion Criteria:

  • gallbladder disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: September 20, 2008
First Posted: September 23, 2008
Last Update Posted: September 23, 2008
Last Verified: September 2008

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

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