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

Cholangiocarcinoma Clinical Trial

— Spy+IDUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369896
• Other study ID #: SpyIDUSForNonictericStricture
• Status: Not yet recruiting
• Start date: May 5, 2024
• Est. completion date: December 25, 2026

Study information

• Verified date: April 2024
• Source: Soonchunhyang University Hospital
• Contact: Jong Ho Moon, Dr.
• Phone: 800-324-2246
• Email: jhmoonsch[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 25, 2026
• Est. primary completion date: December 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients aged 19 to under 80

2. Presence of nonicteric biliary stricture

3. Previous endoscopic sphincterotomy or papillary balloon dilatation

Exclusion Criteria:

1. Bleeding tendency (INR > 1.5 or platelets < 50000 mm3)

2. Contraindication to ERCP

Related Conditions & MeSH terms

• Biliary Stricture
• Cholangiocarcinoma
• Cholestasis
• Constriction, Pathologic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy of SOC	sensitivity, specificity, and accuracy of SOC	From enrollment through study completion, an average of 1 year
Secondary	Diagnostic accuracy of IDUS	sensitivity, specificity, and accuracy of IDUS	From enrollment through study completion, an average of 1 year
Secondary	Technical success of SOC	Successful observation of extrahepatic duct using SOC	From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed
Secondary	Technical success of IDUS	Successful observation of extrahepatic duct using IDUS	From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed
Secondary	Adverse event	All adverse event according to the American Society of Gastrointestinal Endoscopy criteria	From enrollment through study completion, an average of 1 year