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

NCT ID: NCT06369896

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-05

Study Completion Date

2026-12-25

Brief Summary

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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

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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.

Conditions

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Cholangiocarcinoma Biliary Stricture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nonicteric stricture cohort

Patients with nonicteric biliary stricture

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jong Ho Moon

Professor Jong Ho Moon

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jong Ho Moon, Dr.

Role: CONTACT

800-324-2246

Il Sang Shin, Dr.

Role: CONTACT

800-324-2246

Other Identifiers

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SpyIDUSForNonictericStricture

Identifier Type: -

Identifier Source: org_study_id

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