An interventional study of ERCP+ SpyGlass and ESWL+ ERCP in Choledocholithiasis and Common Bile Duct Calculi, sponsored by First People's Hospital of Hangzhou. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by First People's Hospital of Hangzhou · Not applicable, Interventional, and Treatment
Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for choledocholithiasis is a big problem, especially for stones with a diameter greater than 3cm. After ERCP failure, surgery was the option but patients not suitable for surgery were treated through stenting but had to undergo multiple ERCPs and show a success rate of only 44-96%. Recently, choledochoscopic laser, electrohydraulic lithotripsy, SpyGlass, or extracorporeal shock wave lithotripsy (ESWL) have been applied for the treatment of huge bile duct stones. The present study aims to compare the efficacy and safety outcomes of SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large bile duct stones.
ESWL was first used for the removal of renal calculi and ureteral calculi however, now a day is being used for biliary calculi. It has the advantages of simple operation, low cost, and higher safety. Recent studies show that the procedure time for ESWL is also shorter and the utilization rate of mechanical lithotripsy was effectively reduced with fewer complications. But It is difficult for ESWL to break the stones larger than 3cm into small pieces. So SpyGlass-guided laser lithotripsy is used. Spyglass has been used in clinics for more than ten years. Recently, a study reported difficult bile duct stones that were treated with SpyGlass-guided laser lithotripsy that shows promising results. Compared with laser lithotripsy under X-ray monitoring, there is no significant difference in stone removal rate and complication rate between the two methods. However, the effect of lithotripsy under Spyglass direct vision is better, which can break large stones into smaller pieces, thus making it easier to take stones. The investigators conducted the current study to compare the therapeutic outcome and complications between SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large bile duct stones
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's enrollment of 65 is below the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →First People's Hospital of Hangzhou is the lead sponsor of 73 studies on the registry; 28 are open to participants now.
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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.
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Contraindication
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ERCP plus SpyGlass group
Procedure: ERCP+ SpyGlass
ERCP plus ESWL
Procedure: ESWL+ ERCP
SpyGlass direct Vision guided laser lithotripsy
ESWL + Stone removal through ERCP
Clearance rate(percentage)
Stone clearance ratio
Time frame: 1 month
Number of sessions
Number of ERCP procedures
Time frame: 1 month
Complications
Side effect of the procedures
Time frame: 1 month
Procedure Time
Time spent for each surgery
Time frame: Intraoperative
Plan to share: No
Ran from Jan 2021 to primary completion in Dec 2022, 23 months.
Of 41 non-industry interventional studies with no phase under Choledocholithiasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's 23 months is close to that.
Counting every sponsor, half of 43 studies reached it within 21 months; a quarter within 12 and three quarters within 36.
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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First People's Hospital of Hangzhou