Bile Duct Stricture, Biliary Disease, Biliary Tract Neoplasms, Endoscopic Retrograde Cholangiopancreatography
Conditions
Keywords
Bile Duct Stricture, ERCP, Choledochoscopy, Transparent Cap, Biliary biopsy
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.
Interventions
DEVICETransparent 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
Sponsors
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
This is a before-after study. Transparent cap SpyGlass and standard SpyGlass were performed on the same patient successively.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clearness of visual field | Immediately | 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 | Immediately | Comparison of intubation rates between transparent cap SpyGlass and standard SpyGlass |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biopsy accuracy | 1 week | Biopsy accuracy between clear cap SpyGlass and standard SpyGlass was evaluated by comparing the coincidence rate of biopsy histopathology and postoperative pathology |
Countries
China
Contacts
Primary ContactYan Liu, MD
Backup ContactLiang Wu, MD
Outcome results
None listed