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

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.

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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Biliary Stricture Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

diagnostic accuracy of SOC

Time frame: From enrollment through study completion, an average of 1 year

sensitivity, specificity, and accuracy of SOC

Secondary outcomes

Diagnostic accuracy of IDUS

Time frame: From enrollment through study completion, an average of 1 year

sensitivity, specificity, and accuracy of IDUS
Technical success of SOC

Time frame: From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed

Successful observation of extrahepatic duct using SOC
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

Successful observation of extrahepatic duct using IDUS
Adverse event

Time frame: From enrollment through study completion, an average of 1 year

All adverse event according to the American Society of Gastrointestinal Endoscopy criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Il Sang Shin, Dr.

CONTACT

[email protected]

800-324-2246

Jong Ho Moon, Dr.

CONTACT

[email protected]

800-324-2246

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

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

Acronym: Spy+IDUS

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Apr 17, 2024
Registry last updated: Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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