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CompletedNCT00757640CHOLEGASUpdated Feb 15, 2021

Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery

An interventional study of cholecystectomy in Gastric Cancer, sponsored by Italian Research Group for Gastric Cancer. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-15.

Sponsored by Italian Research Group for Gastric Cancer · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Gastric Cancer

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Keywords

  • gastric cancer, surgery, prophylactic cholecystectomy
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In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 150 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Italian Research Group for Gastric Cancer is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients undergoing standard gastric surgery for cancer

Exclusion criteria

Exclusion Criteria:

  • gallbladder disease
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • No intervention
    B

    no cholecystectomy

  • Experimental
    A

    cholecystectomy

    Procedure: cholecystectomy

Interventions

  • Procedurecholecystectomy

    prophylactic cholecystectomy during standard gastric surgery for cancer

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What researchers measure

Primary outcomes

  1. Reduced biliary complications

    Time frame: 5 years

Secondary outcomes

  1. Improved quality of life

    Time frame: 5 years

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Study locations

1 site
  • Azienda Ospedaliero-Universitaria Careggi - Chirurgia Generale ed Oncologica
    Florence, 50134, Italy
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References and documents

Publications

  • 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. PubMed 22948317 ↗
  • 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. PubMed 19445661 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00757640
Lead sponsor
Italian Research Group for Gastric Cancer
Collaborators
Azienda Ospedaliero-Universitaria Careggi
Responsible party
Bencini Lapo (Dr, PhD, Italian Research Group for Gastric Cancer) — Principal investigator
First posted
Sep 23, 2008
Start date
Sep 2008
Primary completion
Sep 2010
Completion
Sep 2015
Last update
Feb 15, 2021

Study contacts

Marco Farsi, MD
principal investigator · Chirurgia Generale e Oncologica Azienda Ospedaliero-Universitaria Careggi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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