NCT02538731

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

August 30, 2015

Last Update Submit

September 1, 2015

Conditions

Sphincterotomy, EndoscopicCholangiopancreatography, Endoscopic RetrogradeLithotripsy, Laser

Outcome Measures

Primary Outcomes (1)

  • Bile Duct Stone Clearance

    1 hour

Study Arms (2)

Dilation-assisted group

OTHER

Dilation-assisted group:Dilation-assisted stone extraction

Procedure: dilation-assisted stone extraction

laser lithotripsy group

OTHER

laser lithotripsy group:laser lithotripsy

Device: Spyglass Guided Laser Lithotrips

Interventions

dilation-assisted stone extractionPROCEDURE
Dilation-assisted group
Spyglass Guided Laser LithotripsDEVICE
laser lithotripsy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bile duct stone \>1.5cm demonstrated on ultrasound, computed tomography, or magnetic resonance imaging

You may not qualify if:

  • Biliary, gallbladder or pancreatic malignancy
  • Pregnant
  • Prior biliary diversion surgery
  • Under age 18
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
guodong li

Study Record Dates

First Submitted

August 30, 2015

First Posted

September 2, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

September 2, 2015

Record last verified: 2015-08