Transparent Cap-assisted SpyGlass for Biliary Stricture

Not Applicable

• Conditions: Bile Duct Stricture; Biliary Disease; Endoscopic Retrograde Cholangiopancreatography; Biliary Tract Neoplasms
• Interventions: Device: Transparent cap

• Registration Number: NCT05320497
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

The transparent cap-assisted endoscope has the function of fixing field of view and increasing visual space. It has been widely used in gastrointestinal examination and treatment. In this study, the investigators intend to apply transparent cap-assisted choledochoscopy to endoscopic biliary tract exploration and biopsy to investigate whether transparent cap-assisted choledochoscopy can improve operability, visual field clarity, and biopsy accuracy.

Detailed Description

Recently, endoscopy has become more widely used in clinical practice. A straightforward method of improving mucosal visualization involves attachment of a transparent cap to the end of the endoscope. It has been widely used in gastrointestinal examination and treatment.This is a before-after study. In patients with suspected bile duct stricture, tandem ERCP combined with SpyGlass choledochoscopy procedures were carried out on the same day in random order, first without a transparent cap and then with a cap (without-to-with), or first with a cap and then without a cap (with-to-without). The differences in maneuverability, visual field clarity and biopsy accuracy of choledochoscopy with and without transparent cap were recorded to explore the application prospect of transparent cap assisted choledochoscopy.

Study Timeline

• Study First Submitted: 2022-03-21
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-02
• Study First Posted: 2022-04-11
• Study Start: 2022-04-14
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-15
• Primary Completion: 2022-07-10
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• The indications for ERCP.
• Written informed consent

Exclusion Criteria

• Underlying bleeding disorder
• The platelet count less than 50×10^9/L
• Serious cardio-pulmonary, hepatic or renal disease
• Intolerance to ERCP
• Other high-risk conditions or disease (such as massive ascites, etc.)
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transparent cap-assisted SpyGlass	Transparent cap	Add a transparent cap to the end of the SpyGlass choledochoscopy

Primary Outcome Measures

Name	Time	Method
The clearness of visual field	Immediately	The clearness of visual field was evaluated by the operating physician and was rated as "clear" or "not clear."
Intubation rates of bile duct ends, cystic duct openings, and left and right hepatic duct bifurcations	Immediately	Comparison of intubation rates between transparent cap SpyGlass and standard SpyGlass

Secondary Outcome Measures

Name	Time	Method
Biopsy accuracy	1 week	Biopsy accuracy between clear cap SpyGlass and standard SpyGlass was evaluated by comparing the coincidence rate of biopsy histopathology and postoperative pathology

Trial Locations

Locations (1)

The Fifth Medical Center of Chinese PLA General Hosptial; 🇨🇳 Beijing, Beijing, China