Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones

Study Overview
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Brief Summary
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Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for pancreatic duct stones is a amjor problem, especially bigger size stones. After ERCP failure, surgery was the only option but patients not suitable for surgery were treated through stenting. But had to undergo multiple ERCPs and show lower success rate. Recently, SpyGlass and extracorporeal shock wave lithotripsy (ESWL) have been applied for the treatment of huge stones. The present study aims to compare the efficacy and safety outcomes of SpyGlass-guided lithotripsy and ESWL procedures for the removal of pancreatic 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 pancreatic duct stones and biliary calculi. It has the advantages of simple operation, lower 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. 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. Investigator conducted the current study to compare the therapeutic outcome and complications between SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large pancreatic duct stones.

Official Title
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Spyglass-guided Lithotripsy Vs ESWL for Pancreatic Duct Stones

Conditions
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Pancreatic Duct Stone

Intervention / Treatment
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* Procedure: Spyglass-guided lithotripsy
* Procedure: ESWL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pancreatic duct sone Falied to eliminate through ERCP only Exclusion Criteria: Pregnancy Refusal of written informed consent Patients not suitable for ESWL/ Spyglass Contraindications to ERCP exist Complicated with acute pancreatitis or acute cholangitis Coagulation dysfunction#thrombocytopenia Patients after gastrointestinal reconstruction Allergic to drugs

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: 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>lithotripsy through Spyglass and ERCP | Procedure: Spyglass-guided lithotripsy<br>* Spyglass-guided lithotripsy<br>* Other names: Direct vision system;|
| Experimental: ESWL group<br>Lithotripsy through ESWL and ERCP | Procedure: ESWL<br>* ESWL+ERCP<br>* Other names: Lithotripsy through ESWL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Successfull intervention | Intraoperative | 
| Clinical success | Pancreatic duct stone clearance rate | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | procedure related adverse events, bleeding, pancreatitis, etc | 1 month | 
| Total number of ERCP | Number of ERCPs performed for stone clearnce | 1 month | 
| Procedure sessions | Total sessions of therapy | 1 month |