Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction (BICRYOB)

Brno University Hospital

Status: Enrolling

Conditions: Biliary Tract Carcinoma; Biliary Obstruction

Treatments: Device: Cryobiopsy catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06047990

FNBKRNM0003

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Cryobiopsy

Experimental group

Description:

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.

Treatment:

Device: Cryobiopsy catheter

Forceps biopsy

Active Comparator group

Description:

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.

Treatment:

Device: Cryobiopsy catheter