NCT05888077

Brief Summary

When conventional endoscopic treatment of bile duct stones is impossible or fails, advanced endoscopy assisted lithotripsy can be performed by electrohydraulic lithotripsy (EHL), laser lithotripsy, or extracorporeal shock wave lithotripsy (ESWL). No systematic review has compared efficacy and safety between these techniques.

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
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

May 25, 2023

Last Update Submit

May 25, 2023

Conditions

Bile Duct Stenosis

Outcome Measures

Primary Outcomes (1)

  • Efficacy ESWL and Laser lithotripsy

    Efficacy of ESWL by Dornier delta III \& Laser lithotripsy in terms of stone clearance rate

    One year

Interventions

ESWL_LLOTHER

Extracorporeal shock wave lithotripsy using latest lithotripter and laser lithotripsy for difficult Bile duct stones

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study is a retrospective analysis of prospectively collected data from the Asian Institute of gastroenterology, India, between January 2019 to December 2022. All patients undergoing biliary ESWL and LL from January 2019 to December 2022 were included in the study.

You may qualify if:

  • Patients with stones that could not be extracted by conventional methods such as biliary sphincterotomy, balloon, basket or mechanical lithotripsy.
  • Patients with biliary stones larger than 15mm.
  • Intrahepatic or cystic duct stones.

You may not qualify if:

  • Pregnancy.
  • Coagulopathy which cannot be corrected.
  • Ongoing cholangitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Neeraj Singla, MD, DM

CONTACT

788861216dr.neerajsingla@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 5, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

June 5, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share