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Completed

NCT Number: NCT05475782

Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones

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.

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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, 310006, 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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Spyglass-guided lithotripsy

Procedure

Spyglass-guided lithotripsy

Other names: Direct vision system

ESWL

Procedure

ESWL+ERCP

Other names: Lithotripsy through ESWL

Primary outcomes

  1. Technical success

    Time frame: Intraoperative

    Successfull intervention

  2. Clinical success

    Time frame: 1 month

    Pancreatic duct stone clearance rate

Secondary outcomes

  1. Adverse events

    Time frame: 1 month

    procedure related adverse events, bleeding, pancreatitis, etc

  2. Total number of ERCP

    Time frame: 1 month

    Number of ERCPs performed for stone clearnce

  3. Procedure sessions

    Time frame: 1 month

    Total sessions of therapy

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

Spyglass-guided Lithotripsy Vs ESWL for Pancreatic Duct Stones

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2022
Registry last updated
May 7, 2026

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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