Transparent Cap-assisted SpyGlass for Biliary Stricture

Biliary Tract Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05320497
• Other study ID #: Transparent Cap
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: April 2022
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Yan Liu, MD
• Phone: 13911798288
• Email: 13911798288[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 30, 2022
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Stricture
• Biliary Disease
• Biliary Tract Neoplasms
• Constriction, Pathologic
• Endoscopic Retrograde Cholangiopancreatography
• Gallbladder Diseases

Intervention

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

Locations

Country	Name	City	State
China	The Fifth Medical Center of Chinese PLA General Hosptial	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clearness of visual field	The clearness of visual field was evaluated by the operating physician and was rated as "clear" or "not clear."	Immediately
Primary	Intubation rates of bile duct ends, cystic duct openings, and left and right hepatic duct bifurcations	Comparison of intubation rates between transparent cap SpyGlass and standard SpyGlass	Immediately
Secondary	Biopsy accuracy	Biopsy accuracy between clear cap SpyGlass and standard SpyGlass was evaluated by comparing the coincidence rate of biopsy histopathology and postoperative pathology	1 week