Transparent Cap-assisted SpyGlass for Biliary Stricture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-14

Study Completion Date

2022-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

"eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis

NCT05905744

Bile Duct Stenosis

UNKNOWN

Contribution of the EyeMAX™ 11Fr (Micro-Tech) Digital Single-Operator Cholangioscope With a Wide Working Channel

NCT06933576

Cholangiocarcinoma Biliary Stenosis Bile Duct Stones +1 more

COMPLETED

Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy

NCT02189421

Common Bile Duct Calculi Biliary Tract Cancer Biliary Stricture +1 more

UNKNOWN NA

The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater

NCT02867826

Ampulla of Vater Intestinal-Type Adenoma

UNKNOWN PHASE2

Purse String Suture Device vs. Endoclip for Immediate Endoscopic Procedure Associated Gastrointestinal Perforation

NCT03053232

Intervention Gastrointestinal Perforation

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bile Duct Stricture Endoscopic Retrograde Cholangiopancreatography Biliary Disease Biliary Tract Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transparent cap-assisted SpyGlass

Add a transparent cap to the end of the SpyGlass choledochoscopy

Group Type EXPERIMENTAL

Transparent cap

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No