Percutaneous Transluminal Forceps Biopsy

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

Completed

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Key information

Conditions

Biliary Stricture Biopsy Wound Neoplasms Oncology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with biliary strictures without histology available

Exclusion criteria

Pregnant patients
Children

Treatment and study plan

biliary biopsy

Procedure

biliary biopsy through a percutaneous approach during a percutaneous biliary drainage

Primary outcomes

Efficacy of PTBD

Time frame: 7 days

Efficacy of PTBD : bilirubinemia after PTFB at Day 7
accuracy for percutaneous biliary biopsy (PTFB)

Time frame: from baseline up to 1 month

Accuracy of PTFB : percentage of true positive and true negative results by pathologists
incidence of PTFB-related adverse events

Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2016
First posted: Sep 15, 2023
Registry last updated: Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed