Bile Duct StenosisNCT05888077
Extracorporeal Shock Wave Lithotripsy Using Latest Lithotripter and Laser Lithotripsy for Difficult Bile Duct Stones
An observational study of Bile Duct Stenosis, run by Asian Institute of Gastroenterology, India.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bile Duct Stenosis
- What is being tested?
- ESWL_LL
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnancy.
- Coagulopathy which cannot be corrected.
- Ongoing cholangitis.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Bile Duct Stenosis
- Being tested
- ESWL_LL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWL_LLOther
Extracorporeal shock wave lithotripsy using latest lithotripter and laser lithotripsy for difficult Bile duct stones
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy ESWL and Laser lithotripsy
Efficacy of ESWL by Dornier delta III \& Laser lithotripsy in terms of stone clearance rate
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct StenosisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888077
- Sponsor's protocol ID
- ESWL_LL
- Status last verified
- May 2023
- First submitted
- 25 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Lithotripsy Using Latest Lithotripter and Laser Lithotripsy for Difficult Bile Duct Stones
- ClinicalTrials.gov ID
- NCT05888077
- Acronym / sponsor ID
- ESWL_LL
- Conditions
- Bile Duct Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy.
- Coagulopathy which cannot be corrected.
- Ongoing cholangitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESWL_LLExtracorporeal shock wave lithotripsy using latest lithotripter and laser lithotripsy for difficult Bile duct stones | Other | – |
Primary outcome
Efficacy ESWL and Laser lithotripsy
Time frame: One year
Efficacy of ESWL by Dornier delta III \& Laser lithotripsy in terms of stone clearance rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Stenosis, run by Asian Institute of Gastroenterology, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neeraj Singla, MD, DM (788861216, dr.neerajsingla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy ESWL and Laser lithotripsy (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.