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Primary Cholangioscopy Versus ERCP in the Diagnosis of Biliary Strictures

NCT04010734 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-07-08

No results posted yet for this study

Summary

The management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Despite the emerging multitudes of new diagnostic opportunities and modalities which exist today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The study´s aim is to compare the diagnostic yield of primary peroral cholangioscopy and ERCP (with conventional sampling - brushing and forceps biopsy - completed with the FISH) in patients with suspected malignant stricture of the common bile duct and to evaluate the impact of both methods on the management of patients with biliary stricture.

Conditions

  • Biliary Stricture

Interventions

PROCEDURE

Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography

The peroral cholangioscopy (DSOC), one of a newer method of endocanal exploration via ERCP- commonly known as the SpyGlass - helps to provide the visual diagnostics of the strictures based on morphological and vascular patterns and to provide directed intraductal biopsy (SpyBite) from the lesions. The combination of both should increase the diagnostic yield in the evaluation of indeterminate biliary stricture by DSOC. ERCP is the most widely used diagnostic procedure in patients with biliary obstruction. It enables to identify the biliary stricture, to determinate its location and help providing tissue sampling from the stricture for cytological evaluation. Different methods were used to take samples from the site of the stenosis. Brushing and endocanal forceps biopsies were the most used techniques. The samples from these two techniques will be additionaly examinated using Fluorescence in Situ Hybridization (FISH).

Sponsors & Collaborators

  • University Hospital Olomouc

    lead OTHER

Principal Investigators

  • Ondrej Urban, MD,pHD · 2nd Department of Internal Medicine, University Hospital Olomouc, Czech Republic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2021-12-20
Completion
2022-06-07

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04010734 on ClinicalTrials.gov