Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction (BICRYOB)

The rationale of the study is to explore the safety and efficacy of percutaneously performed endobiliary cryobiopsy in patiens with histologically unverified biliary stenosis.

Study Overview

• Status: Recruiting
• Conditions: Biliary Tract Carcinoma; Biliary Obstruction
• Intervention / Treatment: Device: Cryobiopsy catheter

Detailed Description

In patients with malignant biliary stenosis in whom endoscopic retrograde cholangiography (ERCP) is not feasible , percutaneous transhepatic drainage (PTD) is indicated. Biopsy is required for further management of the patient. In patients unsuitable for biopsy under CT or endoscopic guidance, samples can be collected endobiliary by PTD. The biopsy vie PTD can be sampled either at the initial drainage using disposable 5.2F forceps or delayed after 2 or more days using 7.5F endobiliary forceps. An alternative to this procedure is endobiliary sampling by cryobiopsy using 1.1mm, 1.7mm or 2.4mm catheters. To minimize bias, each patient will be sampled both by cryobiopsy and forceps biopsy. The order of cryobiopsy and forceps biopsy will be randomized.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomáš Andrašina, MD; Phone Number: +420777674769; Email: andrasina.tomas@fnbrno.cz
• Study Contact Backup: Name: Tomáš Rohan, MD; Phone Number: +420724228684; Email: rohan.tomas@fnbrno.cz

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Recruiting
    • Brno University Hospital
    • Contact: Tomáš Andrašina, MD; Phone Number: +420777674769; Email: andrasina.tomas@fnbrno.cz

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• biliary stenosis of unknown etiology
• unsuccessful or unfeasable ERCP
• indicated percutaneous transhepatic drainage

Exclusion Criteria:

• histologically verified biliary stenosis
• INR ≥ 1,5

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryobiopsy; In randomised patients in experimental arm was initially performed cryobiopsy (3 samples) and cosequently forceps biopsy (6 samples) with 5.2F or 7.5F forceps. Both sampling techniques were performed during one procedure of percutaneous transhepatic drainage under fluoroscopic control.	Device: Cryobiopsy catheter; Comparison of endobiliary forceps biopsy and cryobiopsy of biliary stenosis during percutaneous transhepatic drainage.
Active Comparator: Forceps biopsy; In randomised patients in control arm was initially performed forceps biopsy (6 samples) with 5.2F or 7.5F forceps and cosequently cryobiopsy (3 samples). Both sampling techniques were performed during one procedure of percutaneous transhepatic drainage under fluoroscopic control.	Device: Cryobiopsy catheter; Comparison of endobiliary forceps biopsy and cryobiopsy of biliary stenosis during percutaneous transhepatic drainage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of biopsy sampling to detect malignancy	Comparison of sensitivity of endobiliary cryobiopsy and forceps biopsy for detection of malignancy.	up to month 12 or death of the patient
Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - weight	Comparison of weight (in milligrams) of samples collected by endobiliary cryopsy and forceps biopsy. Each sample will be weighed separately and one measurement value will be recorded for each sample.	up to month 12 or death of the patient
Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - size	Comparison of the size weight (in millimeters) of samples collected by endobiliary cryopsy and forceps biopsy. Each sample will be weighed in two dimensions on slide.	up to month 12 or death of the patient

Collaborators and Investigators

• Sponsor: Brno University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: cryobiopsy; biliary obstruction; percutaneous transhepatic drainage
• Other Study ID Numbers: FNBKRNM0003

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