SpyGlass Versus ESWL for Large Common Bile Duct Stones

Not Applicable

Completed

• Conditions: Common Bile Duct Calculi; Choledocholithiasis
• Interventions: Procedure: ERCP+ SpyGlass; Procedure: ESWL+ ERCP

• Registration Number: NCT05186350
• Lead Sponsor: First People's Hospital of Hangzhou

Brief Summary

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

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

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-11
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-25
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SpyGlass group	ERCP+ SpyGlass	ERCP plus SpyGlass group
ESWL group	ESWL+ ERCP	ERCP plus ESWL

Primary Outcome Measures

Name	Time	Method
Clearance rate(percentage)	1 month	Stone clearance ratio
Number of sessions	1 month	Number of ERCP procedures

Secondary Outcome Measures

Name	Time	Method
Procedure Time	Intraoperative	Time spent for each surgery
Complications	1 month	Side effect of the procedures

Trial Locations

Locations (1)

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