Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction

Not Applicable

Recruiting

• Conditions: Biliary Obstruction; Biliary Tract Carcinoma
• Interventions: Device: Cryobiopsy catheter

• Registration Number: NCT06047990
• Lead Sponsor: Brno University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2023-06-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Forceps biopsy	Cryobiopsy catheter	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.
Cryobiopsy	Cryobiopsy catheter	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.

Primary Outcome Measures

Name	Time	Method
Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - weight	up to month 12 or death of the patient	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.
Sensitivity of biopsy sampling to detect malignancy	up to month 12 or death of the patient	Comparison of sensitivity of endobiliary cryobiopsy and forceps biopsy for detection of malignancy.
Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - size	up to month 12 or death of the patient	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.

Trial Locations

Locations (1)

Brno University Hospital; 🇨🇿 Brno, Czechia