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Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis

NCT04840537 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-04-12

No results posted yet for this study

Summary

Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. In the event of negativity, it is then possible to perform a cholangioscopy in a second step, which allows better sensitivity by performing biopsies. Performing cholangioscopy from the start could potentially save time and avoid disturbances associated with intermediate biliary stenting.

The main objective is to compare two strategies for exploring indeterminate biliary stenosis (1st vs. 2nd line retrograde cholangioscopy) in terms of diagnostic performance. The secondary objectives are to compare the same two strategies in terms of effectiveness, side effects and cost-effectiveness.

The primary outcome measure is the diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).

Conditions

  • Malignant Biliary Stenosis

Interventions

PROCEDURE

endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP

endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage

Sponsors & Collaborators

  • Frederic PRAT, MD, PhD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-26
Primary Completion
2018-12-26
Completion
2022-12-26

Countries

  • France

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 NCT04840537 on ClinicalTrials.gov