NCT05320497

Transparent Cap-assisted SpyGlass for Biliary Stricture

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bile Duct Stricture
• Endoscopic Retrograde Cholangiopancreatography
• Biliary Disease
• Biliary Tract Neoplasms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-04-14
• Primary completion: 2022-07-10
• Completion: 2022-07-30
• First posted: 2022-04-11
• Last updated: 2022-04-15

Locations

1 site across 1 country: China