Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy for Pancreatic Stones

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy for Pancreatic Stones

Conditions
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Pancreatic Duct Stone

Intervention / Treatment
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* Procedure: pancreatic extracorporeal shock wave lithotripsy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Duct Stone, Pancreatic extracorporeal shock wave lithotripsy, Safety, Efficacy