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Not yet recruiting NCT06369896

Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures

— Observational Cholangiocarcinoma Biliary Stricture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cholangiocarcinoma, Biliary Stricture. Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Usefulness of Disposable Digital Single-operator Cholangioscopy and Intraductal Ultrasound in the Assessment of Nonicteric Biliary Strictures: A Prospective Observational Study

Overview

This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture.

Detailed description

Although early and accurate diagnosis of cholangiocarcinoma from the biliary stricture is important, accurate differential diagnosis is still difficult even in computed tomography and magnetic resonance imaging. We planned to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of biliary stricture.

Primary outcome measures

  • diagnostic accuracy of SOC [Time frame: From enrollment through study completion, an average of 1 year]
Secondary outcome measures (4)
  • Diagnostic accuracy of IDUS [Time frame: From enrollment through study completion, an average of 1 year]
  • Technical success of SOC [Time frame: From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed]
  • Technical success of IDUS [Time frame: From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed]
  • Adverse event [Time frame: From enrollment through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Patients aged 19 to under 80
  • Presence of nonicteric biliary stricture
  • Previous endoscopic sphincterotomy or papillary balloon dilatation

Exclusion criteria

  • Bleeding tendency (INR \> 1.5 or platelets \< 50000 mm3)
  • Contraindication to ERCP

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06369896 · SpyIDUSForNonictericStricture

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗