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Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones

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Zhejiang University

Status

Invitation-only

Conditions

Pancreatic Duct Stone

Treatments

Procedure: Spyglass-guided lithotripsy
Procedure: ESWL

Study type

Interventional

Funder types

Other

Identifiers

NCT05475782
2022-07-25

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Spyglass group
Active Comparator group
Description:
lithotripsy through Spyglass and ERCP
Treatment:
Procedure: Spyglass-guided lithotripsy
ESWL group
Experimental group
Description:
Lithotripsy through ESWL and ERCP
Treatment:
Procedure: ESWL

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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