Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery

NCT ID: NCT00757640

Last Updated: 2021-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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B

no cholecystectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

A

cholecystectomy

Group Type EXPERIMENTAL

cholecystectomy

Intervention Type PROCEDURE

prophylactic cholecystectomy during standard gastric surgery for cancer

Interventions

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cholecystectomy

prophylactic cholecystectomy during standard gastric surgery for cancer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing standard gastric surgery for cancer

Exclusion Criteria

* gallbladder disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role collaborator

Italian Research Group for Gastric Cancer

NETWORK

Sponsor Role lead

Responsible Party

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Bencini Lapo

Dr, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Farsi, MD

Role: PRINCIPAL_INVESTIGATOR

Chirurgia Generale e Oncologica Azienda Ospedaliero-Universitaria Careggi

Locations

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Azienda Ospedaliero-Universitaria Careggi - Chirurgia Generale ed Oncologica

Florence, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 22948317 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19445661 (View on PubMed)

Related Links

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http://www.gircg.it/

official site of group study

Other Identifiers

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Firenze 1

Identifier Type: -

Identifier Source: org_study_id

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