Pancreatic Duct StoneNCT05916547
Safety and Efficacy of P-ESWL and ERCP
An observational study of Pancreatic Duct Stone, run by Changhai Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Duct Stone
- What is being tested?
- pancreatic extracorporeal shock wave lithotripsy
- Type of treatment
- Surgery or procedure
- How many people
- 2,071 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in Changhai Hospital from 2011.02.01 to 2018.06.30.
Who may be able to join
- 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.
Who cannot join
- Patients who diagnosed pancreatic cancer within 2 years after diagnosing chronic pancreatitis.
- Patients who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy and Endoscopic Retrograde Cholangiopancreatography for Pancreatic Stones
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.
Read the detailed description
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
- Pancreatic Duct Stone
- Being tested
- pancreatic extracorporeal shock wave lithotripsy
- Keywords
- Pancreatic Duct Stone, Pancreatic extracorporeal shock wave lithotripsy, Safety, Efficacy, endoscopic retrograde cholangiopancreatography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatic extracorporeal shock wave lithotripsyProcedure or surgery
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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 months
Secondary outcomes (2)
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.
Measured: 1 week
Pain relief of patients after P-ESWL and ERCP
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.
Measured: more than 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jun 2023
- Primary completion26 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Duct StoneStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,071 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Liang-hao Hu, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916547
- Sponsor's protocol ID
- SEEPS
- Status last verified
- Jul 2024
- First submitted
- 15 Jun 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25251205Liu 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.
PubMed 39261265Liu 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.
PubMed 39169663
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy and Endoscopic Retrograde Cholangiopancreatography for Pancreatic Stones
- ClinicalTrials.gov ID
- NCT05916547
- Acronym / sponsor ID
- SEEPS
- Conditions
- Pancreatic Duct Stone
- Keywords
- Pancreatic Duct Stone, Pancreatic extracorporeal shock wave lithotripsy, Safety, Efficacy, endoscopic retrograde cholangiopancreatography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,071 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in Changhai Hospital from 2011.02.01 to 2018.06.30.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who diagnosed pancreatic cancer within 2 years after diagnosing chronic pancreatitis.
- Patients who refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pancreatic extracorporeal shock wave lithotripsyPancreatic 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. | Procedure or surgery | – |
Primary outcome
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.
2 secondary outcomes
the rate of pancreatic duct clearance
Time frame: 1 week
Pain relief of patients after P-ESWL and ERCP
Time frame: more than 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Background: PubMed 25251205Li 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.
- Derived from this study: PubMed 39261265Liu 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.
- Derived from this study: PubMed 39169663Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang-hao Hu, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Duct Stone, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of post-ESWL adverse events (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05916547, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.