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Status unknownNCT05888077Updated Jun 5, 2023

Extracorporeal Shock Wave Lithotripsy Using Latest Lithotripter and Laser Lithotripsy for Difficult Bile Duct Stones

An observational study in Bile Duct Stenosis, sponsored by Asian Institute of Gastroenterology, India. Status unknown. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by Asian Institute of Gastroenterology, India · Observational

The sponsor has not verified this record recently (last verified May 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
450
Sex
All
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Study 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.

Read the detailed description

Extracorporeal shock wave lithotripsy (ESWL) and Laser Lithotripsy (LL) have emerged as alternate treatment options for difficult common bile duct (CBD) stones. There is limited data on efficacy and safety of the latest Dornier delta III lithotripter. This study examined the efficacy of ESWL by Dornier delta III \& Laser lithotripsy in terms of stone clearance rate, number of sessions required and safety in a large cohort of patients.

The initial lithotripter models used electrohydraulic energy and required general anesthesia, prone positioning, and water immersion. High clearance rates were reported, but newer models were then developed with use of electromagnetic coils, better focussing, use of a water cushion instead of water immersion, use of ultrasound and then later of digitalised X ray for localisation. The ductal clearance of ESWL is upto 90%. Known complications of this procedure are cholangitis and pancreatitis which occur at the rate of 9-14% apart from minor adverse effects such as pain and local hematoma formation. In a single randomised study that compared intracorporeal lithotripsy(ILL) versus extracorporeal lithotripsy, ILL was found more effective than ESWL in terms of stone clearance rate and treatment duration. However, the lithotripters used in the previous studies were of previous generations, and also commonly used for kidney stones as well. The current study is the first to use the Dornier delta III for the same.

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Conditions studied

  • Bile Duct Stenosis
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In context

Lead sponsor

Asian Institute of Gastroenterology, India is the lead sponsor of 134 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Retrospective
Enrollment
450 participants (estimated)
Patient registry
No

Interventions

  • OtherESWL_LL

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

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What researchers measure

Primary outcomes

  1. Efficacy ESWL and Laser lithotripsy

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

    Time frame: One year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05888077
Responsible party
Sponsor
First posted
Jun 5, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Jul 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Jun 5, 2023

Study contacts

Neeraj Singla, MD, DM
Contact
dr.neerajsingla@gmail.com
788861216

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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