Clinical trial · Observational
Validation of a Score That Predicts Residual Disease in Incidental Gallbladder Cancer
Prospective Validation of a Residual Disease Predictive Score in Incidental Gallbladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): At the beginning of the study, the collaboration of several Spanish liver surgery groups was planned. However, neither group has included a valid record. Likewise, the number of patients studied in our center has been extremely low.
Summary
Brief summary (as posted)
An incidental gallbladder carcinoma is detected in approximately 0.2% of the cholecystectomy specimens removed for presumed benign disease. In patients that meet specific criteria, a surgical re-operation is recommended to treat possible residual tumor disease not treated with the initial cholecystectomy. The presence of residual disease in the re-intervention specimen worsens the prognosis of patient survival, according to several published series. Patients with known or high-risk of residual disease may benefit from a specific strategy that would improve patient selection before attempting re-resection. A pathology-based score has been developed but has not been yet validated in an external series of patients. The use of pathological data from the initial cholecystectomy specimen could identify patients at risk of residual disease and aid in selecting a specific therapeutic strategy prior to attempting surgical re-exploration.
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 |
|---|---|---|---|
| Gallbladder Neoplasm Malignant Primary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Residual disease
- description
- Participants with incidental gallbladder cancer with presence of residual disease in the re-resection specimen or in intra-operative findings.
- interventionNames
- Procedure: Radical surgery
- label
- No residual disease
- description
- Participants with incidental gallbladder cancer with absence of residual disease in the re-resection specimen or in intra-operative findings.
- interventionNames
- Procedure: Radical surgery
Primary outcomes (2)
- measure
- Residual disease
- timeFrame
- Immediately after surgery in operated patients / within 1 year in non-operated patients
- description
- Presence of tumoral cells in the re-resection specimen or found on staging imaging techniques. It can be local (isolated non-discontinuous involvement of the vesicular bed or the cystic stump), regional (common bile duct involvement, perineural, lymph node or neighboring organ invasion), or distant (discontinuous hepatic involvement -i.e. metastases-, peritoneal carcinomatosis or port-site metastases).
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * All consecutive patients with a diagnosis of incidental gallbladder cancer requesting therapeutic evaluation in the participating hospital centers. Exclusion Criteria: * All patients with non-incidental gallbladder cancer. * All patients with incomplete or deficient data collection. * Patients without a signed informed consent.
References
Publications (1)
- RESULTRamos E, Lluis N, Llado L, Torras J, Busquets J, Rafecas A, Serrano T, Mils K, Leiva D, Fabregat J. Prognostic value and risk stratification of residual disease in patients with incidental gallbladder cancer. World J Surg Oncol. 2020 Jan 24;18(1):18. doi: 10.1186/s12957-020-1794-2. PMID 31980034