NCT06974695

Brief Summary

This study aims to optimize the management of complex biliary stones by identifying predictive factors for SpyGlass lithotripsy failure.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 1, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 16, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

May 8, 2025

Last Update Submit

May 8, 2025

Conditions

Bile Duct Stones

Keywords

CholangioscopySpyglassFailureComplex bile duct stonepredictive factorelectrohydraulic lithotripsyEHLlithotripsyERCP

Outcome Measures

Primary Outcomes (1)

  • Predictive factors for failure of cholangioscopy lithotripsy in the management of complex bile duct stone

    Cholangioscopy-guided lithotripsy failure: defined as stone clearance requiring more than one lithotripsy session or surgical intervention

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any adult patient who underwent cholangioscopy-guided lithotripsy for bile duct stones between January 1, 2018, and May 30, 2025

You may qualify if:

  • Any adult patient who underwent cholangioscopy-guided lithotripsy for bile duct stones between January 1, 2018, and May 30, 2025

You may not qualify if:

  • Patient who objected to the collection of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Brabois Vandoeuvre les Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

RECRUITING

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Officials

  • Marion SCHAEFER, hospital practitioner

    STUDY DIRECTOR

Central Study Contacts

Marion SCHAEFER, hospital practitioner

CONTACT

m.schaefer@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hospital practitioner

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 16, 2025

Study Start

May 1, 2025

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

May 16, 2025

Record last verified: 2025-04

Locations

FR(1)