Pancreatic Duct Stone
Conditions
Brief summary
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
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.
Interventions
Spyglass-guided lithotripsy
ESWL+ERCP
Sponsors
Study design
Intervention model description
Parallel Assignment
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Intraoperative | Successfull intervention |
| Clinical success | 1 month | Pancreatic duct stone clearance rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 1 month | procedure related adverse events, bleeding, pancreatitis, etc |
| Total number of ERCP | 1 month | Number of ERCPs performed for stone clearnce |
| Procedure sessions | 1 month | Total sessions of therapy |
Countries
China