Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy for Pancreatic Stones

Pancreatic Duct Stone Clinical Trial

Official title:

Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy for Pancreatic Stones

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916547
• Other study ID #: SEEPS
• Status: Recruiting
• Start date: June 27, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: June 2023
• Source: Changhai Hospital
• Contact: Liang-hao Hu, MD
• Phone: +86-13817593520
• Email: lianghao-hu[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine the types, incidence and risk factors of adverse events after pancreatic extracorporeal shock wave lithotripsy (P-ESWL), define the grading criteria of adverse events after P-ESWL, and analyze the efficacy of P-ESWL, which will provide evidence-based medical evidence to guide physicians' clinical practice.

Description:

Currently, pancreatic extracorporeal shock wave lithotripsy (P-ESWL) has become the preferred treatment for pancreatic duct stones. Although some studies had confirmed the safety and efficacy of P-ESWL, the sample size were small and the follow-up period were short. Therefore, investigators designed this study with a large sample and a long follow-up period to clarify the efficacy and safety of P-ESWL, so as to guide clinical work, standardize the diagnosis and treatment process of adverse events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: August 1, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients hospitalized in Changhai Hospital from 2011.02.01 to 2018.06.30.

• Painful patients with chronic pancreatitis.

• Patients who completed pancreatic extracorporeal shock wave lithotripsy.

Exclusion Criteria:

• Patients who diagnosed pancreatic cancer within 2 years after diagnosing chronic pancreatitis.

• Patients who refused to participate in the study.

Related Conditions & MeSH terms

• Calculi
• Pancreatic Duct Stone

Intervention

Procedure:
• pancreatic extracorporeal shock wave lithotripsy
Pancreatic extracorporeal shock wave lithotripsy is based on the principle of shock wave energy. Whenever energy is abruptly released in an enclosed space, shock waves are generated and then cross to the surface of pancreatic duct stones to cause further fragmentation.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Li BR, Liao Z, Du TT, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Hao JF, Jiang YY, Hu LH, Li ZS. Risk factors for complications of pancreatic extracorporeal shock wave lithotripsy. Endoscopy. 2014 Dec;46(12):1092-100. doi: 10.1055/s-0034-1377753. Epub 2014 Sep 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of post-ESWL adverse events	An adverse event of P-ESWL is classified as either a complication or a transient adverse event (TAE), depending on severity. Complications are recognized as adverse events needing specific medical intervention and prolonged hospitalization, while TAEs are defined as transient injuries caused by shock waves, which required no medical intervention and do not prolong hospitalization.	1 months
Secondary	the rate of pancreatic duct clearance	Complete clearance: more than 90% clearance of stone volume; partial clearance: 50% to 90% clearance of stone volume; unsuccessful clearance: failure to fragment the stones to less than 3 mm diameter or less than 50% clearance of stone volume.	1 week