Safety and Efficacy of P-ESWL and ERCP

Completed

• Conditions: Pancreatic Duct Stone

• Registration Number: NCT05916547
• Lead Sponsor: Changhai Hospital

Brief Summary

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

Detailed Description

Currently, pancreatic extracorporeal shock wave lithotripsy (P-ESWL) and endoscopic retrograde cholangiopancreatography (ERCP) has become the preferred treatment for pancreatic duct stones. Although some studies had confirmed the safety and efficacy of P-ESWL and ERCP, 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 and ERCP, so as to guide clinical work, standardize the diagnosis and treatment process of adverse events.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-23
• Primary Completion: 2024-04-26
• Study Completion: 2024-05-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2071

Inclusion Criteria

• Patients hospitalized in Changhai Hospital from 2011.03.01 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the incidence of post-ESWL adverse events	1 months	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.

Secondary Outcome Measures

Name	Time	Method
the rate of pancreatic duct clearance	1 week	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.
Pain relief of patients after P-ESWL and ERCP	more than 24 months	The ratio of patients with complete pain relief (an Izbicki pain score was ≤ 10), partial relief (an Izbicki pain score \> 10 with a decrease of \> 50%) and no relief.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, China