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NCT Number: NCT05186350

SpyGlass Versus ESWL for Large Common Bile Duct Stones

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP+ SpyGlass

Procedure

SpyGlass direct Vision guided laser lithotripsy

ESWL+ ERCP

Procedure

ESWL + Stone removal through ERCP

Primary outcomes

  1. Clearance rate(percentage)

    Time frame: 1 month

    Stone clearance ratio

  2. Number of sessions

    Time frame: 1 month

    Number of ERCP procedures

Secondary outcomes

  1. Complications

    Time frame: 1 month

    Side effect of the procedures

  2. Procedure Time

    Time frame: Intraoperative

    Time spent for each surgery

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 11, 2022
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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