An interventional study of Transparent cap in Bile Duct Stricture, Endoscopic Retrograde Cholangiopancreatography and Biliary Disease, sponsored by Affiliated Hospital to Academy of Military Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-15.
Sponsored by Affiliated Hospital to Academy of Military Medical Sciences · Not applicable, Interventional, and Device feasibility
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.
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.
92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's planned enrollment of 10 is below the median of 72 across 59 interventional studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases studies →Affiliated Hospital to Academy of Military Medical Sciences is the lead sponsor of 67 studies on the registry; 10 are open to participants now.
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Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The clearness of visual field
The clearness of visual field was evaluated by the operating physician and was rated as "clear" or "not clear."
Time frame: 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
Time frame: Immediately
Biopsy accuracy
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
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2022 (actual). Primary completion is estimated for Jul 2022, 2 months after the start.
Of 32 non-industry interventional studies with no phase under Gallbladder Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's planned 2 months is below that.
Counting every sponsor, half of 34 studies reached it within 14 months; a quarter within 8 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Affiliated Hospital to Academy of Military Medical Sciences