NCT06189664

Brief Summary

Evaluate the effectiveness of intra-operative frozen section in the treatment of gallbladder cancer. The study will be looking in to identify if intraoperative frozen section is a viable method to intraoperatively evaluate the presence of adenocarcinoma and the depth of its invasion and if the information given by frozen section is enough to modify the operative strategy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

8 years

First QC Date

December 19, 2023

Last Update Submit

December 19, 2023

Conditions

Gallbladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Detection of adenocarcinoma

    immediately during frozen section

Interventions

Frozen sectionDIAGNOSTIC_TEST

Frozen section analysis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected GB Cancer

You may qualify if:

  • \- Patients with suspected GB cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Banh S, Fehervari M, Flod S, Soleimani-Nouri P, Leyte Golpe A, Ahmad R, Pai M, Spalding DRC. Single stage management of suspected gallbladder cancer guided by intraoperative frozen section analysis: a retrospective cohort study. Int J Surg. 2024 Oct 1;110(10):6314-6320. doi: 10.1097/JS9.0000000000001456.

    PMID: 38704628DERIVED

MeSH Terms

Conditions

Gallbladder Neoplasms

Interventions

Frozen Sections

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Intervention Hierarchy (Ancestors)

CryoultramicrotomyMicrotomyHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 3, 2024

Study Start

January 1, 2013

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 3, 2024

Record last verified: 2023-12