Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones

Not Applicable

• Conditions: Pancreatic Duct Stone
• Interventions: Procedure: ESWL; Procedure: Spyglass-guided lithotripsy

• Registration Number: NCT05475782
• Lead Sponsor: First People's Hospital of Hangzhou

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-13
• Last Update Posted: 2023-08-15
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESWL group	ESWL	Lithotripsy through ESWL and ERCP
Spyglass group	Spyglass-guided lithotripsy	lithotripsy through Spyglass and ERCP

Primary Outcome Measures

Name	Time	Method
Clinical success	1 month	Pancreatic duct stone clearance rate
Technical success	Intraoperative	Successfull intervention

Secondary Outcome Measures

Name	Time	Method
Adverse events	1 month	procedure related adverse events, bleeding, pancreatitis, etc
Procedure sessions	1 month	Total sessions of therapy
Total number of ERCP	1 month	Number of ERCPs performed for stone clearnce

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China