Validation of a Score That Predicts Residual Disease in Incidental Gallbladder Cancer

NCT ID: NCT04321577

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-04-30

Brief Summary

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.

Detailed Description

• Sample size: 30 (minimum).
• Statistical analysis: populations will be compared with chi-square test or Fisher's exact test (categorical variables) and Student's t test or Mann-Whitney U test (continuous variables). A univariate and multivariate logistic regression analysis will be performed to evaluate the predictive factors of residual disease. The Kaplan-Meier method will be applied for survival analysis and curves will be compared using log-rank test. Univariate and multivariate Cox proportional hazards ratio will be applied to determine the predictive factors of survival. Variables with p values inferior to 0.1 in the univariate analysis will be used to perform the multivariate analysis. Statistical significance is defined when p < 0.5. The statistical program used will be SPSS version 23.

Conditions

Gallbladder Neoplasm Malignant Primary

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Residual disease

Participants with incidental gallbladder cancer with presence of residual disease in the re-resection specimen or in intra-operative findings.

Radical surgery

Intervention Type: PROCEDURE

Radical surgery is proposed to participants with pT1b, pT2 or pT3 tumors in the cholecystectomy specimen without evidence of disseminated disease with staging imaging techniques. A resection of the gallbladder bed or an anatomic resection of the hepatic segments IVb/V is performed. A lymphadenectomy of the hepatic hilum is associated in all cases. Common bile duct resection is performed in patients with involvement of the cystic margin.

No residual disease

Participants with incidental gallbladder cancer with absence of residual disease in the re-resection specimen or in intra-operative findings.

Radical surgery

Intervention Type: PROCEDURE

Radical surgery is proposed to participants with pT1b, pT2 or pT3 tumors in the cholecystectomy specimen without evidence of disseminated disease with staging imaging techniques. A resection of the gallbladder bed or an anatomic resection of the hepatic segments IVb/V is performed. A lymphadenectomy of the hepatic hilum is associated in all cases. Common bile duct resection is performed in patients with involvement of the cystic margin.

Interventions

Radical surgery

Radical surgery is proposed to participants with pT1b, pT2 or pT3 tumors in the cholecystectomy specimen without evidence of disseminated disease with staging imaging techniques. A resection of the gallbladder bed or an anatomic resection of the hepatic segments IVb/V is performed. A lymphadenectomy of the hepatic hilum is associated in all cases. Common bile duct resection is performed in patients with involvement of the cystic margin.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emilio Ramos

OTHER

Sponsor Role: lead

Responsible Party

Emilio Ramos

Medical doctor, PhD, head of hepatic surgery, university professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Laura Lladó, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Bellvitge

Kristel Mills Julià, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Bellvitge

Locations

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Countries

Spain

References

Ramos 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.

Reference Type: RESULT

PMID: 31980034 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/31980034

Direct link to the previously cited article.

Other Identifiers

PR357/19

Identifier Type: -

Identifier Source: org_study_id