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Laser Lithotripsy for Difficult Large Bile Duct Stones

NCT02538731 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-09-02

No results posted yet for this study

Summary

Very large bile duct stones are difficult to remove. Dilation-assisted stone extraction, also termed small endoscopic sphincterotomy plus endoscopic papillary large balloon dilatation, is safe and effective technique for the treatment of large CBD stones. However, in approximately 5-10% of patients, the removal of large bile duct stones may be difficult. For this selected group of patients for whom all conventional endoscopic stone treatment devices have failed, laser lithotripsy technology has provided an approach to the fragmentation of difficult bile duct stones.

A single-operator cholangioscopy (SOC) system (SpyGlass Direct Visualization System, Boston Scientific Corp., Natick, MA, USA) has overcome most of the conventional cholangioscopy limitations. The investigators aimed to evaluate the efficacy and safety of Spyglass-guided laser lithotripsy for difficult CBD stones not amenable to conventional dilation-assisted stone extraction therapy.

Conditions

  • Sphincterotomy, Endoscopic
  • Cholangiopancreatography, Endoscopic Retrograde
  • Lithotripsy, Laser

Interventions

PROCEDURE

dilation-assisted stone extraction

DEVICE

Spyglass Guided Laser Lithotrips

Sponsors & Collaborators

  • Shandong Provincial Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-08-31
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02538731 on ClinicalTrials.gov