BICRYOB: Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction

Sponsor

Brno University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06047990

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Carcinoma Biliary Obstruction	Device: Cryobiopsy catheter	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Masking Description:

Randomization was performed by the Institute of Biostatistics and Analysis of Masaryk University Brno.

Primary Purpose:

Diagnostic

Official Title:

Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 - 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

histologically verified biliary stenosis
INR ≥ 1,5

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brno University Hospital	Brno		Czechia	62500

Sponsors and Collaborators

Brno University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tomas Andrasina, Tomáš Andrašina, MD, PhD; Assistant professor, Head of Non-vascular interventions and Computed Tomography of the Department of Radiology and Nuclear Medicine, Brno University Hospital

ClinicalTrials.gov Identifier:

NCT06047990

Other Study ID Numbers:

FNBKRNM0003

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tomas Andrasina, Tomáš Andrašina, MD, PhD; Assistant professor, Head of Non-vascular interventions and Computed Tomography of the Department of Radiology and Nuclear Medicine, Brno University Hospital

cryobiopsy

biliary obstruction

percutaneous transhepatic drainage

Study Results

No Results Posted as of Sep 21, 2023