Spyglass-guided Lithotripsy Versus ESWL for Pancreatic Duct Stones

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pancreatic Duct Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Spyglass group

lithotripsy through Spyglass and ERCP

Group Type ACTIVE_COMPARATOR

Spyglass-guided lithotripsy

Intervention Type PROCEDURE

Spyglass-guided lithotripsy

ESWL group

Lithotripsy through ESWL and ERCP

Group Type EXPERIMENTAL

ESWL

Intervention Type PROCEDURE

ESWL+ERCP

Interventions

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Spyglass-guided lithotripsy

Intervention Type PROCEDURE

ESWL

ESWL+ERCP

Intervention Type PROCEDURE

Other Intervention Names

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Direct vision system Lithotripsy through ESWL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No