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OpenTrials
Completed

NCT Number: NCT00757640

Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero-Universitaria Careggi - Chirurgia Generale ed Oncologica

Florence, 50134, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing standard gastric surgery for cancer

Exclusion criteria

  • gallbladder disease

Treatment and study plan

Cholecystectomy

Procedure

prophylactic cholecystectomy during standard gastric surgery for cancer

Primary outcomes

  1. Reduced biliary complications

    Time frame: 5 years

Secondary outcomes

  1. Improved quality of life

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Italian Research Group for Gastric Cancer

Network

Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

Registry information

Official study 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.

Acronym: CHOLEGAS

Important dates

Study start
2008
Primary completion
2010
Study completion
2015
First posted
Sep 23, 2008
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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