Safety and Efficacy of P-ESWL and ERCP

NCT05916547 | Completed

• 1 other identifier: SEEPS
• Study Type: observational
• Target: 2,071
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Duct Stone

Keywords

Pancreatic Duct Stone; Pancreatic extracorporeal shock wave lithotripsy; Safety; Efficacy; endoscopic retrograde cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the rate of pancreatic duct clearance

  1 week

• Pain relief of patients after P-ESWL and ERCP

  more than 24 months

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in Changhai Hospital from 2011.02.01 to 2018.06.30.

You may qualify if:

• 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.

You may not qualify if:

• Patients who diagnosed pancreatic cancer within 2 years after diagnosing chronic pancreatitis.
• Patients who refused to participate in the study.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (3)

• 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.

  PMID: 25251205 BACKGROUND

• Liu Y, Yi JH, Wang PY, Fu P, Kang Y, Wang T, Zhang D, Zhang XH, Xu JJ, Zhang SL, Han PD, Wang F, Zhou XY, Feng JS, Xu JJ, Qian JH, Wang D, Chen H, Liu RH, Wang FY, Li ZS, Hu LH. Safety evaluation of extracorporeal shockwave lithotripsy for pancreatic stones: Experience based on a large chronic pancreatitis cohort. Dig Liver Dis. 2025 Feb;57(2):417-426. doi: 10.1016/j.dld.2024.08.043. Epub 2024 Sep 11.

  PMID: 39261265 DERIVED

• Liu Y, Yin XY, Cui JH, Wang T, Feng XY, Yi JH, Xu JJ, Zhang SL, Han PD, Wang D, Liu RH, Wang FY, Li ZS, Hu LH. Long-term clinical outcomes of extracorporeal shockwave lithotripsy and endoscopic retrograde cholangiopancreatography for pancreatic duct stone treatment in patients with chronic pancreatitis. Aliment Pharmacol Ther. 2024 Oct;60(8):1110-1121. doi: 10.1111/apt.18224. Epub 2024 Aug 21.

  PMID: 39169663 DERIVED

Study Officials

• Liang-hao Hu, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 23, 2023
• Study Start: June 1, 2023
• Primary Completion: April 26, 2024
• Study Completion: May 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)