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Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones

Spyglass-guided Lithotripsy Vs ESWL for Pancreatic Duct Stones

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05475782
Enrollment
80
Registered
2022-07-27
Start date
2021-01-01
Completion date
2023-11-30
Last updated
2023-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Duct Stone

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.

Interventions

PROCEDURESpyglass-guided lithotripsy

Spyglass-guided lithotripsy

PROCEDUREESWL

ESWL+ERCP

Sponsors

First People's Hospital of Hangzhou
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Technical successIntraoperativeSuccessfull intervention
Clinical success1 monthPancreatic duct stone clearance rate

Secondary

MeasureTime frameDescription
Adverse events1 monthprocedure related adverse events, bleeding, pancreatitis, etc
Total number of ERCP1 monthNumber of ERCPs performed for stone clearnce
Procedure sessions1 monthTotal sessions of therapy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026