Post-ERCP PancreatitisPhase 4NCT00820612
Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
A Phase 4 study testing Indomethacin in people with Post-ERCP Pancreatitis, run by University of Michigan at 4 sites in United States.
Trial summary
Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Pancreatitis
- What is being tested?
- Indomethacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 602 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2009to Jul 2011
- 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
- Included patients are those undergoing ERCP and have one of the following:
- Clinical suspicion of sphincter of Oddi dysfunction
- History of post-ERCP pancreatitis (at least one episode)
- Pancreatic sphincterotomy
- Pre-cut (access) sphincterotomy
- > 8 cannulation attempts
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- Pneumatic dilation of intact biliary sphincter
- Ampullectomy
- or at least 2 of the following:
- Age < 50 years old \& female gender
- History of recurrent pancreatitis (at least 2 episodes)
- ≥3 pancreatic injections, with at least one injection to tail
- Pancreatic acinarization
- Pancreatic brush cytology
Who cannot join
- Unwillingness or inability to consent for the study
- Age < 18 years
- Intrauterine pregnancy
- Breast feeding mother
- Standard contraindications to ERCP
- Allergy to Aspirin or NSAIDs
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- Renal failure (Cr > 1.4)
- Active or recent (within 4 weeks) gastrointestinal hemorrhage
- Acute pancreatitis (lipase peak) within 72 hours
- Known chronic calcific pancreatitis
- Pancreatic head malignancy
- Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla)
- ERCP for biliary stent removal or exchange without anticipated pancreatogram
- Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
- Anticipated inability to follow protocol
- Endoscopist discretion: low risk (<10%) of post-ERCP pancreatitis
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Indiana University Medical Center
Indianapolis, Indiana, 46202
University of Kentucky
Lexington, Kentucky, 40536
About this study
Official title: A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.
Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.
Read the detailed description
This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.
- Conditions
- Post-ERCP Pancreatitis
- Being tested
- Indomethacin, Placebo suppositories
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndomethacinDrug
100 mg PR once at the time of ERCP
Placebo suppositoriesOther
2 placebo suppositories at the time of ERCP
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Indomethacin suppository Receives: Drug: Indomethacin |
| 2 | Placebo comparator | Placebo suppository Receives: Other: Placebo suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ERCP Pancreatitis
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Stopped by DSMB for overwhelming benefit of indomethacin (unethical to withhold indomethacin from patients)
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 (1)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP PancreatitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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, Care provider, Investigator
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, University of Kentucky, Case Western Reserve University
- Responsible party
- Principal investigator, Badih Joseph Elmunzer, University of Michigan
- Investigators
- Badih J Elmunzer, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820612
- Sponsor's protocol ID
- HUM00022847
- Status last verified
- Feb 2013
- First submitted
- 9 Jan 2009
- Last updated
- 28 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.
PubMed 22494121
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
- ClinicalTrials.gov ID
- NCT00820612
- Acronym / sponsor ID
- HUM00022847
- Conditions
- Post-ERCP Pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped by DSMB for overwhelming benefit of indomethacin (unethical to withhold indomethacin from patients)
- Enrolment
- 602 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Indiana University, University of Kentucky, Case Western Reserve University
- Study start
- Jan 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Posted 12 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.
Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.
Detailed description
This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: IndomethacinIndomethacin suppository |
| 2 | Placebo comparator | Other: Placebo suppositoriesPlacebo suppository |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Clinical suspicion of sphincter of Oddi dysfunction
- History of post-ERCP pancreatitis (at least one episode)
- Pancreatic sphincterotomy
- Pre-cut (access) sphincterotomy
- > 8 cannulation attempts
Key exclusion criteria (16 listed)
- Unwillingness or inability to consent for the study
- Age < 18 years
- Intrauterine pregnancy
- Breast feeding mother
- Standard contraindications to ERCP
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 |
|---|---|---|
| Indomethacin100 mg PR once at the time of ERCP | Drug | 1 |
| Placebo suppositories2 placebo suppositories at the time of ERCP | Other | 2 |
Primary outcome
Post-ERCP Pancreatitis
Time frame: 5 days
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22494121Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.
Related trials for Post-ERCP Pancreatitis
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Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis
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Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
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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.
Badih J Elmunzer, MD principal investigator
University of Michigan
4 sites 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 in people with Post-ERCP Pancreatitis, run by University of Michigan at 4 sites in United States.
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 14 inclusion and 16 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: stopped early, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 12 Feb 2013). 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?
Post-ERCP Pancreatitis (time frame: 5 days). 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 NCT00820612, which also lists 1 linked publication.
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 28 Feb 2013.