Transparent Cap-assisted SpyGlass for Biliary Stricture

NCT05320497 | Unknown

• 1 other identifier: Transparent Cap
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Bile Duct Stricture; ERCP; Choledochoscopy; Transparent Cap; Biliary biopsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Biopsy accuracy

  1 week

Study Arms (1)

Transparent cap-assisted SpyGlass

EXPERIMENTAL

Add a transparent cap to the end of the SpyGlass choledochoscopy

Device: Transparent cap

Interventions

Transparent cap DEVICE

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

Transparent cap-assisted SpyGlass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The indications for ERCP.
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

The Fifth Medical Center of Chinese PLA General Hosptial

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Conditions

Gallbladder Diseases; Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Yan Liu, MD

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Liu, MD

CONTACT

13911798288; 13911798288@163.com

Liang Wu, MD

CONTACT

13911058553; wuliangdoc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 11, 2022
• Study Start: April 14, 2022
• Primary Completion: July 10, 2022
• Study Completion: July 30, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)