Transparent Cap-assisted SpyGlass for Biliary Stricture

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05320497

Collaborator

(none)

Enrollment

Location

Arm

3.5

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bile Duct Stricture Endoscopic Retrograde Cholangiopancreatography Biliary Disease Biliary Tract Neoplasms	Device: Transparent cap	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a before-after study. Transparent cap SpyGlass and standard SpyGlass were performed on the same patient successively.This is a before-after study. Transparent cap SpyGlass and standard SpyGlass were performed on the same patient successively.

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Application of Transparent Cap-assisted Digital Cholangioscopy (SpyGlassTM) for Biliary Stricture

Actual Study Start Date :

Apr 14, 2022

Anticipated Primary Completion Date :

Jul 10, 2022

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transparent cap-assisted SpyGlass Add a transparent cap to the end of the SpyGlass choledochoscopy	Device: Transparent cap Add a self-made transparent cap (made by cutting a silicone drainage tube) to the end of the SpyGlass choledochoscope, and then perform routine choledochoscopy and biopsy operations

Arm

Intervention/Treatment

Experimental: Transparent cap-assisted SpyGlass

Add a transparent cap to the end of the SpyGlass choledochoscopy

Device: Transparent cap

Add a self-made transparent cap (made by cutting a silicone drainage tube) to the end of the SpyGlass choledochoscope, and then perform routine choledochoscopy and biopsy operations

Outcome Measures

Primary Outcome Measures

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

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