Transparent Cap-assisted SpyGlass for Biliary Stricture
Primary Purpose
Bile Duct Stricture, Endoscopic Retrograde Cholangiopancreatography, Biliary Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transparent cap
Sponsored by
About this trial
This is an interventional device feasibility trial for Bile Duct Stricture focused on measuring Bile Duct Stricture, ERCP, Choledochoscopy, Transparent Cap, Biliary biopsy
Eligibility Criteria
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
Sites / Locations
- The Fifth Medical Center of Chinese PLA General HosptialRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transparent cap-assisted SpyGlass
Arm Description
Add a transparent cap to the end of the SpyGlass choledochoscopy
Outcomes
Primary Outcome Measures
The clearness of visual field
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
Comparison of intubation rates between transparent cap SpyGlass and standard SpyGlass
Secondary Outcome Measures
Biopsy accuracy
Biopsy accuracy between clear cap SpyGlass and standard SpyGlass was evaluated by comparing the coincidence rate of biopsy histopathology and postoperative pathology
Full Information
NCT ID
NCT05320497
First Posted
March 21, 2022
Last Updated
April 14, 2022
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05320497
Brief Title
Transparent Cap-assisted SpyGlass for Biliary Stricture
Official Title
Application of Transparent Cap-assisted Digital Cholangioscopy (SpyGlassTM) for Biliary Stricture
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
July 10, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Stricture, Endoscopic Retrograde Cholangiopancreatography, Biliary Disease, Biliary Tract Neoplasms
Keywords
Bile Duct Stricture, ERCP, Choledochoscopy, Transparent Cap, Biliary biopsy
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a before-after study. Transparent cap SpyGlass and standard SpyGlass were performed on the same patient successively.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transparent cap-assisted SpyGlass
Arm Type
Experimental
Arm Description
Add a transparent cap to the end of the SpyGlass choledochoscopy
Intervention Type
Device
Intervention Name(s)
Transparent cap
Intervention Description
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
Primary Outcome Measure Information:
Title
The clearness of visual field
Description
The clearness of visual field was evaluated by the operating physician and was rated as "clear" or "not clear."
Time Frame
Immediately
Title
Intubation rates of bile duct ends, cystic duct openings, and left and right hepatic duct bifurcations
Description
Comparison of intubation rates between transparent cap SpyGlass and standard SpyGlass
Time Frame
Immediately
Secondary Outcome Measure Information:
Title
Biopsy accuracy
Description
Biopsy accuracy between clear cap SpyGlass and standard SpyGlass was evaluated by comparing the coincidence rate of biopsy histopathology and postoperative pathology
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Liu, MD
Phone
13911798288
Email
13911798288@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Wu, MD
Phone
13911058553
Email
wuliangdoc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liu, MD
Organizational Affiliation
Beijing 302 Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fifth Medical Center of Chinese PLA General Hosptial
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Liu, MD
Phone
+8613911798288
Email
13911798288@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transparent Cap-assisted SpyGlass for Biliary Stricture
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