- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05916547
Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy for Pancreatic Stones
June 27, 2023 updated by: Zhaoshen Li, Changhai Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
2500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhao-shen Li, MD
- Phone Number: +86-13901960921
- Email: zhaoshen-li@hotmail.com
Study Contact Backup
- Name: Liang-hao Hu, MD
- Phone Number: +86-13817593520
- Email: lianghao-hu@smmu.edu.cn
Study Locations
-
-
-
Shanghai, China, 200433
- Recruiting
- Changhai Hospital
-
Principal Investigator:
- Yu Liu
-
Contact:
- Zhao-shen Li, MD
- Phone Number: +86-13901960921
- Email: zhaoshen-li@hotmail.com
-
Contact:
- Liang-hao Hu, MD
- Phone Number: +86-13817593520
- Email: lianghao-hu@smmu.edu.cn
-
Principal Investigator:
- Jin-hui Yi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients hospitalized in Changhai Hospital from 2011.02.01 to 2018.06.30.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Liang-hao Hu, MD, Changhai Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2023
Primary Completion (Estimated)
July 26, 2023
Study Completion (Estimated)
August 1, 2023
Study Registration Dates
First Submitted
June 15, 2023
First Submitted That Met QC Criteria
June 15, 2023
First Posted (Actual)
June 23, 2023
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEEPS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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Clinical Trials on pancreatic extracorporeal shock wave lithotripsy
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Erasme University HospitalCompletedPancreatitisBelgium, Italy
-
Sohag UniversityCompletedDetermine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age GroupEgypt
-
Chinese University of Hong KongWithdrawnHypertension | Renal StoneHong Kong
-
Washington University School of MedicineTerminatedUrolithiasisUnited States
-
University of Colorado, DenverEnrolling by invitationPancreatitis, ChronicUnited States
-
Ain Shams UniversityScience,Technology & Innovation Funding AuthorityRecruitingAcute Kidney Injury | Renal Calculi | Percutaneous Nephrolithotomy | Extracorporeal Shockwave LithotripsyEgypt
-
Imam Abdulrahman Bin Faisal UniversityCompleted
-
Mansoura UniversityUnknown
-
EgymedicalpediaCompletedStone, Kidney | Child, OnlyEgypt