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

NCT04321577 | Withdrawn

• 1 other identifier: PR357/19
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallbladder Neoplasm Malignant Primary

Keywords

Residual disease; Risk score

Outcome Measures

Primary Outcomes (2)

• Residual disease

  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

  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 Outcomes (2)

• Disease-specific survival

  1, 3, and 5-year disease-specific survival.

• Disease-free survival

  1, 3, and 5-year disease-free survival.

Study Arms (2)

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

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

Interventions

Radical surgery 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; Residual disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All consecutive patients with a diagnosis of incidental gallbladder cancer requesting therapeutic evaluation in the participating hospital centers.

You may not qualify if:

• All patients with non-incidental gallbladder cancer.
• All patients with incomplete or deficient data collection.
• Patients without a signed informed consent.

Sponsors & Collaborators

• Emilio Ramos: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (1)

• 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.

  PMID: 31980034 RESULT

Related Links

• Direct link to the previously cited article.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cholecystectomy and re-resection specimen. Both of the fixed, sliced with a microtome in sections and stained with hematoxylin-eosin at the Pathology Laboratory.

MeSH Terms

Conditions

Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Lladó, MD, PhD

  Hospital Universitari Bellvitge

  PRINCIPAL INVESTIGATOR

• Kristel Mills Julià, MD

  Hospital Universitari Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor, PhD, head of hepatic surgery, university professor

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 25, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: September 2, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)