Clinical trial NCT04321577: Validation of a Score That Predicts Residual Disease in Incidental Gallbladder Cancer
Official title: Prospective Validation of a Residual Disease Predictive Score in Incidental Gallbladder Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gallbladder Neoplasm Malignant Primary
Keywords: Residual disease
Risk score
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of incidental gallbladder cancer that request therapeutic evaluation in the participating hospital centers.

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.

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.

Primary outcomes:
measure: Residual disease
timeFrame: Immediately after surgery in operated patients / within 1 year in non-operated patients
measure: Gallbladder cancer risk score
timeFrame: Baseline
Secondary outcomes:
measure: Disease-specific survival
timeFrame: 1, 3, and 5-year disease-specific survival.
measure: Disease-free survival
timeFrame: 1, 3, and 5-year disease-free survival.
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital Universitari Bellvitge
name: Laura Lladó, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Bellvitge
name: Kristel Mills Julià, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.