Percutaneous Transluminal Forceps Biopsy

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Completed
• CT.gov ID: NCT06039670
• Collaborator: (none)
• Enrollment: 50
• Actual Duration (Months): 19.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Biliary Stricture; Biopsy Wound; Oncology	Procedure: biliary biopsy

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Percutaneous Transluminal Forceps Biopsy Combined With Transhepatic Biliary Drainage in the Management of Patients With Obstructive Jaundice: Efficacy, Safety and Accuracy
• Actual Study Start Date: Jan 2, 2015
• Actual Primary Completion Date: Jul 31, 2015
• Actual Study Completion Date: Aug 31, 2016

Outcome Measures

Primary Outcome Measures

1. Efficacy of PTBD [7 days]

   Efficacy of PTBD : bilirubinemia after PTFB at Day 7

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with biliary strictures without histology available

Exclusion Criteria:

• Pregnant patients

• Children

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital, Caen

Investigators

• Principal Investigator: Audrey Fohlen, Caen UH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT06039670
• Other Study ID Numbers: PTFB
• First Posted: Sep 15, 2023
• Last Update Posted: Sep 15, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Constriction, Pathologic

Study Results

No Results Posted as of Sep 15, 2023