Percutaneous Transluminal Forceps Biopsy

Completed

• Conditions: Oncology; Biliary Stricture; Biopsy Wound

• Registration Number: NCT06039670
• Lead Sponsor: University Hospital, Caen

Brief Summary

To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous transluminal forceps biopsy combined with transhepatic biliary drainage in patients with biliary stricture

Detailed Description

Biological parameters of liver function, histopathology of specimens, comparison with others clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy, endoscopic biopsy) were recorded Comparison between pathological findings of surgery or endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up of the patient 12 months after biopsy Evaluation of complications, accuracy

Study Timeline

• Study Start: 2015-01-02
• Primary Completion: 2015-07-31
• Study Completion: 2016-08-31
• Study First Submitted: 2017-12-11
• Status Verified: 2023-06
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study First Posted: 2023-09-15
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with biliary strictures without histology available

Exclusion Criteria

• Pregnant patients
• Children

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of PTBD	7 days	Efficacy of PTBD : bilirubinemia after PTFB at Day 7
incidence of PTFB-related adverse events	up to 1 month after procedure	Number of patients with PTFB related adverse-events as assessed by Society of Interventional Radiology Standards of Practice Committee classification
accuracy for percutaneous biliary biopsy (PTFB)	from baseline up to 1 month	Accuracy of PTFB : percentage of true positive and true negative results by pathologists