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Completed

NCT Number: NCT05916547

Safety and Efficacy of P-ESWL and ERCP

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.

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Key information

Conditions

Pancreatic Duct Stone

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital

Shanghai, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pancreatic extracorporeal shock wave lithotripsy

Procedure

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.

Primary outcomes

  1. the incidence of post-ESWL adverse events

    Time frame: 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 outcomes

  1. the rate of pancreatic duct clearance

    Time frame: 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.

  2. Pain relief of patients after P-ESWL and ERCP

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy and Endoscopic Retrograde Cholangiopancreatography for Pancreatic Stones

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2023
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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