NCT00757640

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

September 20, 2008

Last Update Submit

February 10, 2021

Conditions

Gastric Cancer

Keywords

gastric cancer, surgery, prophylactic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Reduced biliary complications

    5 years

Secondary Outcomes (1)

  • Improved quality of life

    5 years

Study Arms (2)

B

NO INTERVENTION

no cholecystectomy

A

EXPERIMENTAL

cholecystectomy

Procedure: cholecystectomy

Interventions

cholecystectomyPROCEDURE

prophylactic cholecystectomy during standard gastric surgery for cancer

A

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing standard gastric surgery for cancer

You may not qualify if:

  • gallbladder disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria Careggi - Chirurgia Generale ed Oncologica

Florence, 50134, Italy

Location

Related Publications (2)

  • Bernini M, Bencini L, Sacchetti R, Marchet A, Cristadoro L, Pacelli F, Berardi S, Doglietto GB, Rosa F, Verlato G, Cozzaglio L, Bechi P, Marrelli D, Roviello F, Farsi M; Italian Research Group for Gastric Cancer (IRGGC). The Cholegas Study: safety of prophylactic cholecystectomy during gastrectomy for cancer: preliminary results of a multicentric randomized clinical trial. Gastric Cancer. 2013 Jul;16(3):370-6. doi: 10.1007/s10120-012-0195-9. Epub 2012 Sep 5.

    PMID: 22948317DERIVED

  • Farsi M, Bernini M, Bencini L, Miranda E, Manetti R, de Manzoni G, Verlato G, Marrelli D, Pedrazzani C, Roviello F, Marchet A, Cristadoro L, Gerard L, Moretti R; GIRCG (Gruppo Italiano di Ricerca sul Cancro Gastrico). The CHOLEGAS study: multicentric randomized, blinded, controlled trial of gastrectomy plus prophylactic cholecystectomy versus gastrectomy only, in adults submitted to gastric cancer surgery with curative intent. Trials. 2009 May 15;10:32. doi: 10.1186/1745-6215-10-32.

    PMID: 19445661DERIVED

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marco Farsi, MD

    Chirurgia Generale e Oncologica Azienda Ospedaliero-Universitaria Careggi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, PhD

Study Record Dates

First Submitted

September 20, 2008

First Posted

September 23, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2015

Last Updated

February 15, 2021

Record last verified: 2021-02

Locations

IT(1)