Post-ERCP Acute PancreatitisIndomethacinNCT02002650
Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
A study testing Pre-ERCP rectal Indomethacin and Post-operational Rectal Indomethacin in people with Post-ERCP Acute Pancreatitis, run by Air Force Military Medical University, China at 6 sites in China.
Trial summary
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- Pre-ERCP rectal Indomethacin and Post-operational Rectal Indomethacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,600 participants
- Where
- 6 sitesChina
- Study dates
- Dec 2013to Nov 2015
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing diagnostic or therapeutic ERCP.
Who cannot join
- Unwillingness or inability to consent for the study;
- Age < 18 years old;
- Intrauterine pregnancy;
- Breastfeeding mother;
- Standard contraindications to ERCP;
- Allergy to NSAIDs;
Show all 15Show fewer
- Received NSAIDs in prior 7 days;
- Renal failure (Cr >1.4mg/dl=120umol/l);
- Active or recurrent (within 4 weeks) gastrointestinal hemorrhage;
- Acute pancreatitis within 72 hours;
- Known pancreatic head mass;
- Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;
- ERCP for biliary stent removal or exchange without anticipated pancreatogram;
- Known active cardiovascular or cerebrovascular disease.
- Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Urumqi General Hospital of Lanzhou Military Region
Ürümqi, Xinjiang, 830002
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
No. 451 Hospital
Xi'an, Shaanxi, 710054
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
General Hospital of NingXia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Pre-ERCP rectal Indomethacin, Post-operational Rectal Indomethacin
- Keywords
- Indomethacin, pancreatitis, ERCP
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-ERCP rectal IndomethacinDrug
Rectal Indomethacin was administrated within 30min before ERCP in all patients.
Post-operational Rectal IndomethacinDrug
Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.
| Study group | Role | What they receive |
|---|---|---|
| Pre-ERCP group | Experimental | Pre-ERCP rectal Indomethacin in all patients. Receives: Drug: Pre-ERCP rectal Indomethacin |
| Post-ERCP group | Active comparator | Post-ERCP rectal Indomethacin in high-risk patients. Receives: Drug: Post-operational Rectal Indomethacin |
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, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.
Measured: 30 days
Secondary outcomes (1)
Moderate-to-severe Pancreatitis
Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2015
- Study completionNov 2015
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 (3)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP Acute PancreatitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
- Investigators
- Yanglin Pan, M.D., Study director, Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002650
- Sponsor's protocol ID
- 20131106-7
- Other IDs
- 20131106-7
- Acronym
- Indomethacin
- Status last verified
- May 2016
- First submitted
- 1 Dec 2013
- Last updated
- 29 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ding X, Chen M, Huang S, Zhang S, Zou X. Nonsteroidal anti-inflammatory drugs for prevention of post-ERCP pancreatitis: a meta-analysis. Gastrointest Endosc. 2012 Dec;76(6):1152-9. doi: 10.1016/j.gie.2012.08.021.
PubMed 23164513Elmunzer 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 22494121Luo H, Zhao L, Leung J, Zhang R, Liu Z, Wang X, Wang B, Nie Z, Lei T, Li X, Zhou W, Zhang L, Wang Q, Li M, Zhou Y, Liu Q, Sun H, Wang Z, Liang S, Guo X, Tao Q, Wu K, Pan Y, Guo X, Fan D. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet. 2016 Jun 4;387(10035):2293-2301. doi: 10.1016/S0140-6736(16)30310-5. Epub 2016 Apr 28.
PubMed 27133971
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02002650
- Acronym / sponsor ID
- Indomethacin / 20131106-7
- Conditions
- Post-ERCP Acute Pancreatitis
- Keywords
- Indomethacin, pancreatitis, ERCP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,600 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Posted 27 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-ERCP group | Experimental | Drug: Pre-ERCP rectal IndomethacinPre-ERCP rectal Indomethacin in all patients. |
| Post-ERCP group | Active comparator | Drug: Post-operational Rectal IndomethacinPost-ERCP rectal Indomethacin in high-risk patients. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing diagnostic or therapeutic ERCP.
Key exclusion criteria (15 listed)
- Unwillingness or inability to consent for the study;
- Age < 18 years old;
- Intrauterine pregnancy;
- Breastfeeding 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 |
|---|---|---|
| Pre-ERCP rectal IndomethacinRectal Indomethacin was administrated within 30min before ERCP in all patients. | Drug | Pre-ERCP group |
| Post-operational Rectal IndomethacinRectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not. | Drug | Post-ERCP group |
Primary outcome
Post-ERCP Pancreatitis
Time frame: 30 days
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.
1 secondary outcome
Moderate-to-severe Pancreatitis
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23164513Ding X, Chen M, Huang S, Zhang S, Zou X. Nonsteroidal anti-inflammatory drugs for prevention of post-ERCP pancreatitis: a meta-analysis. Gastrointest Endosc. 2012 Dec;76(6):1152-9. doi: 10.1016/j.gie.2012.08.021.
- Results publication: 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.
- Derived from this study: PubMed 27133971Luo H, Zhao L, Leung J, Zhang R, Liu Z, Wang X, Wang B, Nie Z, Lei T, Li X, Zhou W, Zhang L, Wang Q, Li M, Zhou Y, Liu Q, Sun H, Wang Z, Liang S, Guo X, Tao Q, Wu K, Pan Y, Guo X, Fan D. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet. 2016 Jun 4;387(10035):2293-2301. doi: 10.1016/S0140-6736(16)30310-5. Epub 2016 Apr 28.
Related trials for Post-ERCP Acute Pancreatitis
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Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
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Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
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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.
Yanglin Pan, M.D. study director
Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-ERCP rectal Indomethacin and Post-operational Rectal Indomethacin in people with Post-ERCP Acute Pancreatitis, run by Air Force Military Medical University, China at 6 sites 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 1 inclusion and 15 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 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 27 May 2016). 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: 30 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 NCT02002650, 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 29 Jun 2016.