Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction

NCT06047990 | Unknown

• 1 other identifier: FNBKRNM0003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Carcinoma; Biliary Obstruction

Keywords

cryobiopsy; biliary obstruction; percutaneous transhepatic drainage

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Cryobiopsy

EXPERIMENTAL

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

Forceps biopsy

ACTIVE COMPARATOR

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

Interventions

Cryobiopsy catheter DEVICE

Comparison of endobiliary forceps biopsy and cryobiopsy of biliary stenosis during percutaneous transhepatic drainage.

Cryobiopsy; Forceps biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• histologically verified biliary stenosis
• INR ≥ 1,5

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

Brno University Hospital

Brno, 62500, Czechia

RECRUITING

Central Study Contacts

Tomáš Andrašina, MD

CONTACT

+420777674769; andrasina.tomas@fnbrno.cz

Tomáš Rohan, MD

CONTACT

+420724228684; rohan.tomas@fnbrno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization was performed by the Institute of Biostatistics and Analysis of Masaryk University Brno.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tomáš Andrašina, MD, PhD; Assistant professor, Head of Non-vascular interventions and Computed Tomography of the Department of Radiology and Nuclear Medicine

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 21, 2023
• Study Start: June 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)