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

August 28, 2021 updated by: Emilio Ramos

Prospective Validation of a Residual Disease Predictive Score in Incidental Gallbladder Cancer

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of incidental gallbladder cancer that request therapeutic evaluation in the participating hospital centers.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Residual disease
Participants with incidental gallbladder cancer with presence of residual disease in the re-resection specimen or in intra-operative findings.
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.
No residual disease
Participants with incidental gallbladder cancer with absence of residual disease in the re-resection specimen or in intra-operative findings.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual disease
Time Frame: Immediately after surgery in operated patients / within 1 year in non-operated patients
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).
Immediately after surgery in operated patients / within 1 year in non-operated patients
Gallbladder cancer risk score
Time Frame: Baseline
Pathology-based score that uses T stage, grade of differentiation, presence of lymphovascular and perineural invasion evaluated in the cholecystectomy specimen to pre-operatively predict the presence of residual disease after radical resection. Each factor is assigned a value. Adding these values results in a total risk score that ranges between 3 and 10 points. The scores are separated intro three risk groups: low (3-4), intermediate (5-7) and high (8-10).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-specific survival
Time Frame: 1, 3, and 5-year disease-specific survival.
Interval between date of surgical re-exploration and date of last follow-up or death. Only death from cancer will be considered an event in the analysis. Non-cancer related deaths will be excluded from the analysis.
1, 3, and 5-year disease-specific survival.
Disease-free survival
Time Frame: 1, 3, and 5-year disease-free survival.
Interval between date of surgical re-exploration and date of recurrence diagnosis (clinic, radiologic or pathologic) or last follow-up or death in patients without recurrence.
1, 3, and 5-year disease-free survival.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emilio Ramos

Investigators

  • Principal Investigator: Laura Lladó, MD, PhD, Hospital Universitari Bellvitge
  • Principal Investigator: Kristel Mills Julià, MD, Hospital Universitari Bellvitge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

April 1, 2021

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (ACTUAL)

March 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 28, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR357/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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