Safety and Efficacy of P-ESWL and ERCP

NCT ID: NCT05916547

Last Updated: 2024-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2071 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-05-01

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) 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

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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.

Conditions

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Pancreatic Duct Stone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liang-hao Hu, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 25251205 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39261265 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39169663 (View on PubMed)

Other Identifiers

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SEEPS

Identifier Type: -

Identifier Source: org_study_id

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