- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05888077
Extracorporeal Shock Wave Lithotripsy Using Latest Lithotripter and Laser Lithotripsy for Difficult Bile Duct Stones
Study Overview
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Neeraj Singla, MD, DM
- Phone Number: 788861216
- Email: dr.neerajsingla@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- Pregnancy.
- Coagulopathy which cannot be corrected.
- Ongoing cholangitis.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy ESWL and Laser lithotripsy
Time Frame: One year
|
Efficacy of ESWL by Dornier delta III & Laser lithotripsy in terms of stone clearance rate
|
One year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ESWL_LL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bile Duct Stenosis
-
Changhai HospitalThe First Affiliated Hospital of Nanchang University; LanZhou University; West... and other collaboratorsNot yet recruitingBile Duct Stenosis
-
Johann Wolfgang Goethe University HospitalInstitutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian... and other collaboratorsCompleted
-
Shandong UniversityRecruitingEndoscopic Retrograde Cholangiopancreatography | Stenosis of Bile DuctChina
-
University of FloridaSpectranetics CorporationWithdrawnBile Duct Obstruction | Biliary Tract Disease
-
Innovative Digestive Health Education and Research...NinePoint MedicalUnknownCholangiocarcinoma | Bile Duct Cancer | Primary Sclerosing Cholangitis | Bile Duct Diseases | Pancreatic Ductal Adenocarcinoma | Pancreas Cancer | Bile Duct Neoplasms | Biliary Stricture | Bile Duct Obstruction | Bile Duct Obstruction, Extrahepatic | Pancreatic Duct Stricture | Bile Duct Lesions | Bile Duct Neoplasms... and other conditionsUnited States
-
Wake Forest University Health SciencesCompletedCalculi | Stenosis of Bile DuctUnited States
-
Instituto Ecuatoriano de Enfermedades DigestivasUniversity of Sao Paulo; Universitair Ziekenhuis Brussel; The Methodist Hospital... and other collaboratorsCompletedCommon Bile Duct Neoplasms | Non-Neoplastic Bile Duct DisorderUnited States, Ecuador, Belgium, Brazil
-
Inje UniversityCompletedNeoplasms | Bile Duct Obstruction | Disorder of Bile Duct StentKorea, Republic of
-
Gujranwala medical college District Headquarters...RecruitingCommon Bile Duct Diseases | Common Bile Duct Calculi | Common Bile Duct Stricture | Common Bile Duct Neoplasms | Common Bile Duct DilatationPakistan
-
Istituto Clinico HumanitasRecruitingMalignant Bile Duct ObstructionItaly