PancreatitisPhase 4RIPEPNCT02797067
Rectal Indomethacin to Prevent Post ESWL-pancreatitis
A Phase 4 study testing indomethacin suppository and Glycerin Suppository in people with Pancreatitis, run by Changhai Hospital at 1 site in China.
Trial summary
The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- indomethacin suppository and Glycerin Suppository
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,370 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2016to Aug 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL
- at least 18 years old
- provides informed consent
Who cannot join
- readmitted to the hospital during the enrollment of the study
- contraindications to ESWL
- suspected or established malignancy
- pancreatic ascites
- receiving NSAIDs within 7 days
- contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or renal dysfunction with serum creatinine >120 μmol/L)
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- presence of coagulopathy or received anticoagulation therapy within 3 days
- acute pancreatitis within 3 days
- known active cardiovascular or cerebrovascular disease
- pregnant or breastfeeding women
- without a rectum (ie, status post-total proctocolectomy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)
The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis.
Read the detailed description
It is a prospective, double-blind, randomized controlled trial. Patients with painful chronic pancreatitis and pancreatic stones (> 5 mm in diameter) who are treated with ESWL at Changhai Hospital will be randomly allocated to indomethacin or placebo therapy before the procedure.
- Conditions
- Pancreatitis
- Being tested
- indomethacin suppository, Glycerin Suppository
- Keywords
- Extracorporeal Shock Wave lithotripsy(ESWL), Prophylaxis, Indomethacin, Chronic pancreatitis
- Medical subject headings
- Pancreatitis, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indomethacin suppositoryDrug
100mg rectal indomethacin 30min before ESWL
Glycerin SuppositoryDrug
30min before ESWL
| Study group | Role | What they receive |
|---|---|---|
| Indomethacin | Experimental | Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. Receives: Drug: indomethacin suppository |
| Glycerin | Placebo comparator | Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL. Receives: Drug: Glycerin Suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Incidence of Post-ESWL Pancreatitis
Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.
Measured: up to 1 months
Secondary outcomes (2)
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications
Asymptomatic hyperamylasemia was defined as an increase in serum amylase compared with pre-ESWL levels and beyond the upper limit of the normal range but showing no related symptoms. Serum amylase will be measured in all study patients at 3 and 24 hours after the procedure and subsequently at clinical discretion.
Other post-ESWL complications including bleeding, infection, steinstrasse and perforation.
Bleeding is related to clinical evidence，the level of hemoglobin ( measured at 24 hours after the procedure and at clinical discretion) and treatments.
Infection is related to temperature and treatment. Steinstrasse is related to abdominal pain degree and the combination of other complications.
Perforation is related to treatment.
Measured: up to 1 months
the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ）
Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment.
Measured: up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start31 May 2016
- Primary completionJul 2019
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797067
- Sponsor's protocol ID
- ESWL-pancreatitis
- Acronym
- RIPEP
- Status last verified
- Mar 2022
- First submitted
- 29 May 2016
- Last updated
- 26 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qian YY, Ru N, Chen H, Zou WB, Wu H, Pan J, Li B, Xin L, Guo JY, Tang XY, Hu LH, Jin ZD, Wang D, Du YQ, Wang LW, Li ZS, Liao Z. Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):238-244. doi: 10.1016/S2468-1253(21)00434-9. Epub 2022 Jan 25.
PubMed 35085482Qian YY, Chen H, Tang XY, Jiang X, Qian W, Zou WB, Xin L, Li B, Qi YF, Hu LH, Zou DW, Jin ZD, Wang D, Du YQ, Wang LW, Liu F, Li ZS, Liao Z. Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial. Trials. 2017 Nov 2;18(1):513. doi: 10.1186/s13063-017-2250-7.
PubMed 29096689
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)
- ClinicalTrials.gov ID
- NCT02797067
- Acronym / sponsor ID
- RIPEP / ESWL-pancreatitis
- Conditions
- Pancreatitis
- Keywords
- Extracorporeal Shock Wave lithotripsy(ESWL), Prophylaxis, Indomethacin, Chronic pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,370 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Posted 26 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis.
Detailed description
It is a prospective, double-blind, randomized controlled trial. Patients with painful chronic pancreatitis and pancreatic stones (> 5 mm in diameter) who are treated with ESWL at Changhai Hospital will be randomly allocated to indomethacin or placebo therapy before the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indomethacin | Experimental | Drug: indomethacin suppositorySubjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. |
| Glycerin | Placebo comparator | Drug: Glycerin SuppositorySubjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL
- at least 18 years old
- provides informed consent
Key exclusion criteria (11 listed)
- readmitted to the hospital during the enrollment of the study
- contraindications to ESWL
- suspected or established malignancy
- pancreatic ascites
- receiving NSAIDs within 7 days
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 |
|---|---|---|
| indomethacin suppository100mg rectal indomethacin 30min before ESWL | Drug | Indomethacin |
| Glycerin Suppository30min before ESWL | Drug | Glycerin |
Primary outcome
the Incidence of Post-ESWL Pancreatitis
Time frame: up to 1 months
Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.
2 secondary outcomes
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications
Time frame: up to 1 months
the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ）
Time frame: up to 1 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35085482Qian YY, Ru N, Chen H, Zou WB, Wu H, Pan J, Li B, Xin L, Guo JY, Tang XY, Hu LH, Jin ZD, Wang D, Du YQ, Wang LW, Li ZS, Liao Z. Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):238-244. doi: 10.1016/S2468-1253(21)00434-9. Epub 2022 Jan 25.
- Derived from this study: PubMed 29096689Qian YY, Chen H, Tang XY, Jiang X, Qian W, Zou WB, Xin L, Li B, Qi YF, Hu LH, Zou DW, Jin ZD, Wang D, Du YQ, Wang LW, Liu F, Li ZS, Liao Z. Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial. Trials. 2017 Nov 2;18(1):513. doi: 10.1186/s13063-017-2250-7.
- 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.
Zhuan Liao, 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?
A Phase 4 study testing indomethacin suppository and Glycerin Suppository in people with Pancreatitis, 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 11 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 26 May 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Pancreatitis (time frame: up to 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 NCT02797067, which also lists 2 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 26 May 2022.