Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction

Conditions
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Biliary Tract Carcinoma, Biliary Obstruction

Intervention / Treatment
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* Device: Cryobiopsy catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: biliary stenosis of unknown etiology unsuccessful or unfeasable ERCP indicated percutaneous transhepatic drainage Exclusion Criteria: histologically verified biliary stenosis INR ≥ 1,5

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryobiopsy<br>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<br>* Comparison of endobiliary forceps biopsy and cryobiopsy of biliary stenosis during percutaneous transhepatic drainage.<br>|
| Active Comparator: Forceps biopsy<br>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<br>* Comparison of endobiliary forceps biopsy and cryobiopsy of biliary stenosis during percutaneous transhepatic drainage.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryobiopsy, biliary obstruction, percutaneous transhepatic drainage