Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2025-12-17 @ 8:38 AM
Study NCT ID:
NCT05888077
Status:
None
Last Update Posted:
2023-06-05 00:00:00
First Post:
2023-05-25 00:00:00
Brief Title:
Extracorporeal Shock Wave Lithotripsy Using Latest Lithotripter and Laser Lithotripsy for Difficult Bile Duct Stones
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology, India
Study Overview
Official Title:
Extracorporeal Shock Wave Lithotripsy Using Latest Lithotripter and Laser Lithotripsy for Difficult Bile Duct Stones
Status:
None
Status Verified Date:
2023-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 lithotripsyILL 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
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 lithotripsyILL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None