SpyGlass Versus ESWL for Large Common Bile 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

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-01-25

Brief Summary

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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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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 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

Conditions

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Choledocholithiasis Common Bile Duct Calculi

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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SpyGlass group

ERCP plus SpyGlass group

Group Type ACTIVE_COMPARATOR

ERCP+ SpyGlass

Intervention Type PROCEDURE

SpyGlass direct Vision guided laser lithotripsy

ESWL group

ERCP plus ESWL

Group Type ACTIVE_COMPARATOR

ESWL+ ERCP

Intervention Type PROCEDURE

ESWL + Stone removal through ERCP

Interventions

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ERCP+ SpyGlass

SpyGlass direct Vision guided laser lithotripsy

Intervention Type PROCEDURE

ESWL+ ERCP

ESWL + Stone removal through ERCP

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No