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

NCT04321577 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-09-02

No results posted yet for this study

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.

Conditions

  • Gallbladder Neoplasm Malignant Primary

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Emilio Ramos

    lead OTHER

Principal Investigators

  • Laura Lladó, MD, PhD · Hospital Universitari Bellvitge

  • Kristel Mills Julià, MD · Hospital Universitari Bellvitge

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-03-31
Completion
2021-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321577 on ClinicalTrials.gov