Percutaneous Transluminal Forceps Biopsy

Percutaneous Transluminal Forceps Biopsy Combined With Transhepatic Biliary Drainage in the Management of Patients With Obstructive Jaundice: Efficacy, Safety and Accuracy

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

Study Overview

• Status: Completed
• Conditions: Oncology; Biliary Stricture; Biopsy Wound
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with obstructive jaundice referred for percutaneous transhepatic biliary drainage without histological diagnosis

Description

Inclusion Criteria:

• Patients with biliary strictures without histology available

Exclusion Criteria:

• Pregnant patients
• Children

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Audrey Fohlen, Caen UH

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2015
• Primary Completion (Actual): July 31, 2015
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: PTFB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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