SpyGlass Versus ESWL for Large Common Bile Duct Stones

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Comparison of SpyGlass Guided Lithotripsy Versus Extracorporeal Shockwaves Lithotripsy for Large Common Bile Duct Stones

Conditions
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Choledocholithiasis, Common Bile Duct Calculi

Intervention / Treatment
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* Procedure: ERCP+ SpyGlass
* Procedure: ESWL+ ERCP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: large bile duct stones (≥10 mm) Exclusion Criteria: pregnancy refusal of written informed consent Patients with benign or malignant biliary stricture Contraindications to ERCP exist Complicated with acute pancreatitis or acute cholangitis Coagulation dysfunction#thrombocytopenia Patients after gastrointestinal reconstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SpyGlass group<br>ERCP plus SpyGlass group | Procedure: ERCP+ SpyGlass<br>* SpyGlass direct Vision guided laser lithotripsy<br>|
| Active Comparator: ESWL group<br>ERCP plus ESWL | Procedure: ESWL+ ERCP<br>* ESWL + Stone removal through ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance rate(percentage) | Stone clearance ratio | 1 month | 
| Number of sessions | Number of ERCP procedures | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Side effect of the procedures | 1 month | 
| Procedure Time | Time spent for each surgery | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choledocholithiasis; SpyGlass; ESWL;ERCP