Evaluation of the Effectiveness of Intraoperative Frozen... | NCT06189664

Studies
Evaluation of the Effectiveness of Intraoperative Frozen Section on the Treatment of Suspected Gallbladder Cancer

NCT06189664

Sponsor

Imperial College London

Status

Completed

Last Update Posted

Jan 3, 2024Actual

Enrollment

37Actual

Phase

Not provided

Conditions

Gallbladder Cancer

Interventions

Frozen section

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2013Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Dec 19, 2023

First Submission Date that Met QC Criteria

Dec 19, 2023

First Posted Date

Jan 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2023

Last Update Posted Date

Jan 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Name	Type	Description	Arm Group Labels	Other Names
Frozen section	Diagnostic Test	Frozen section analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of adenocarcinoma		immediately during frozen section

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients with suspected GB cancer

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with suspected GB Cancer

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38704628	Derived	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.

ID	Term
D001661	Biliary Tract Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D016616	Cryoultramicrotomy
D008867	Microtomy
D016591	Histocytological Preparation Techniques
D003584	Cytological Techniques