Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction

Biliary Obstruction Clinical Trial

— BICRYOB  

Official title:

Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047990
• Other study ID #: FNBKRNM0003
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Brno University Hospital
• Contact: Tomáš Andrašina, MD
• Phone: +420777674769
• Email: andrasina.tomas[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• biliary stenosis of unknown etiology

• unsuccessful or unfeasable ERCP

• indicated percutaneous transhepatic drainage

Exclusion Criteria:

• histologically verified biliary stenosis

• INR = 1,5

Related Conditions & MeSH terms

• Biliary Obstruction
• Biliary Tract Carcinoma

Intervention

Device:
• Cryobiopsy catheter
Comparison of endobiliary forceps biopsy and cryobiopsy of biliary stenosis during percutaneous transhepatic drainage.

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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