Percutaneous Transluminal Forceps Biopsy

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06039670
• Other study ID #: PTFB
• Status: Completed
• Start date: January 2, 2015
• Est. completion date: August 31, 2016

Study information

• Verified date: June 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2016
• Est. primary completion date: July 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with biliary strictures without histology available

Exclusion Criteria:

• Pregnant patients

• Children

Related Conditions & MeSH terms

• Biliary Stricture
• Biopsy Wound
• Constriction, Pathologic
• Oncology

Intervention

Procedure:
• biliary biopsy
biliary biopsy through a percutaneous approach during a percutaneous biliary drainage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of PTBD	Efficacy of PTBD : bilirubinemia after PTFB at Day 7	7 days
Primary	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
Primary	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