Clinical trial · Interventional
Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery
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.
NCT00757640CI-TRIAL-00050061CHOLEGAScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cholecystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- B
- description
- no cholecystectomy
- type
- EXPERIMENTAL
- label
- A
- description
- cholecystectomy
- interventionNames
- Procedure: cholecystectomy
Primary outcomes (1)
- measure
- Reduced biliary complications
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Improved quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing standard gastric surgery for cancer Exclusion Criteria: * gallbladder disease
References
Publications (2)
- DERIVEDBernini 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 22948317
- DERIVEDFarsi 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 19445661