Transparent Cap-assisted SpyGlass for Biliary Stricture

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

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.

Study Overview

• Status: Recruiting
• Conditions: Endoscopic Retrograde Cholangiopancreatography; Biliary Tract Neoplasms; Biliary Disease; Bile Duct Stricture
• Intervention / Treatment: Device: Transparent cap

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Liu, MD; Phone Number: 13911798288; Email: 13911798288@163.com
• Study Contact Backup: Name: Liang Wu, MD; Phone Number: 13911058553; Email: wuliangdoc@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Recruiting
      • The Fifth Medical Center of Chinese PLA General Hosptial
      • Contact: Yan Liu, MD; Phone Number: +8613911798288; Email: 13911798288@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Principal Investigator: Yan Liu, MD, Beijing 302 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Anticipated): July 10, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 2, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: ERCP; Bile Duct Stricture; Choledochoscopy; Transparent Cap; Biliary biopsy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Pathological Conditions, Anatomical; Biliary Tract Diseases; Constriction, Pathologic; Biliary Tract Neoplasms; Gallbladder Diseases
• Other Study ID Numbers: Transparent Cap

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No