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ERCPNCT07071441

Indomethacin vs Diclofenac for Preventing PEP

A study testing Indomethacin 100 MG and Diclofenac 100mg in people with ERCP and Pancreatitis, run by Air Force Military Medical University, China at 20 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Pancreatitis is the most common and serious complication following post-endoscopic retrograde cholangiopancreatography (ERCP) and is associated with occasional mortality, extended hospital stays, and increased healthcare expenses. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Indomethacin 100 MG and Diclofenac 100mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,050 participants
Where
20 sitesChina
Study dates
1 Jun 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 18-90 years old patients with native papilla who planned to undergo ERCP

Who cannot join

  • Previous biliary sphincterotomy and papillary large balloon dilation
  • Planned for placements of pancreatic duct stents (eg. pancreatic duct strictures, planned ampullectomy)
  • Allergy to NSAIDs
  • The administration of NSAIDs within 7 days
  • Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction [Cr >1.4mg/dl=120umol/l]; presence of coagulopathy before the procedure)
  • Acute pancreatitis within 7 days before ERCP or acute pancreatitis with obvious Pancreatic edema and peripancreatic fluid collections
Show all 9Show fewer
  • Hemodynamical instability
  • Pregnancy or lactation
  • Unable to give informed consent

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yanglin Pan, MD contact

86-84771536

yanglinpan@hotmail.com

20 sites in 1 country

China20 sites, 20 recruiting
  • The first medical center, Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100000

    Yaqi Zhai, 86-13810105934, astaring@163.com

    Recruiting
  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

    Zhao Lei, 86-13469438509, leizhao1987@outlook.com

    Not yet recruiting
  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 404100

    Bo Ning, 86-13996476336, ningbo@hospital.cqmu.edu.cn

    Recruiting
  • Affiliated Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310000

    Xiaofeng Zhang, 86-13758250208, zhangxiaofeng@hospital.westlake.edu.cn

    Not yet recruiting
  • the First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Kangjie Chen, 86-18989487755, ckj_zyyy@zju.edu.cn

    Recruiting
  • the second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Jiamin Chen, 86-13505811655, 13505811655@139.com

    Not yet recruiting
  • Harbin Medical University Affiliated Fourth Hospital

    Harbin, Heilongjiang, 150000

    Liguo Wang, 86-13654553324, wangliguo8314000@sina.com

    Recruiting
  • Zhaolei181220@163.Com

    Harbin, Heilongjiang, 150000

    Lei Zhao, 86-18745143401

    Recruiting
  • Jilin Miniciple People'S Hospital

    Jilin City, Jilin, 132000

    Xiang Guo, 86-18104421678, 18223115@qq.com

    Recruiting
  • Shandong Provincial Third Hospital

    Jinan, Shandong, 250000

    Ming zhang, 86-13791112618, mklaolong@163.com

    Not yet recruiting
  • The 960th Hospital of the PLA

    Jinan, Shandong, 250000

    Xiaofeng Liu, 86-13969179611, dolphinj228@hotmail.com

    Recruiting
  • Huaihe Hospital of Henan University

    Kaifeng, Hennan, 475000

    Jianghai Zhao, 86-13700782780, 123154765@qq.com

    Recruiting
  • Eastern Hepatobiliary Surgery Hospital

    Shanghai, Shanghai Municipality, 200000

    Mingxing Xia, 86-13906524284, xiamingxing1982@126.com

    Recruiting
  • Renmin hospital of Wuhan University

    Wuhan, Hubei, 430000

    Xinyue Wan, 86-13986265930, wanjiao8250@163.com

    Recruiting
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Bing Wang, 86-13307171656, 2013tj0575@just.edu.cn

    Recruiting
  • 986 Hospital of Xijing Hospital

    Xi'an, Shaanxi, 710000

    Jun Wang, 86-13669252896, wangjundoctor@aliyun.com

    Recruiting
  • Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710000

    Gang Zhao, 86-13892867489, zhaogang799@mail.xjtu.edu.cn

    Recruiting
  • Xijing Hospital of Digestive Diseases

    Xi'an, Shaanxi, 710000

    Recruiting
  • Department of Gastroenterology, Hongai Hospital

    Xiamen, Fujian, 361000

    Rongchun Zhang, MD, +8618841185362, 11906188847@qq.com

    Recruiting
  • Qinghai University Affiliated Hospital

    Xining, Qinghai, 810000

    Li Ren, 86-18997291606, 290761084@qq.com

    Recruiting

Other trials in China

About this study

Official title: Rectal Indomethacin Versus Diclofenac for Prevention of Post-ERCP Panceratitis (IDPPP2): A Multicenter, Double-blind, Randomized, Control Trial

Pancreatitis is the most common and serious complication following post-endoscopic retrograde cholangiopancreatography (ERCP) and is associated with occasional mortality, extended hospital stays, and increased healthcare expenses. Preprocedural administration of rectal non-steroidal anti-inflammatory drugs (NSAIDs) was demonstrated to be an effective and convenient strategy for post-ERCP pancreatitis (PEP). Furthermore, several meta-analyses found that only 100mg indomethacin and diclofenac could effectively reduce PEP. Therefore, updated international clinical practice guidelines uniformly recommended administration of 100mg indomethacin or diclofenac in patients without contradictions. However, it was unclear which one of the two drug is more superior.

A recent meta-analysis suggested 100mg rectal diclofenac was more efficacious than same-dose rectal indomethacin in PEP prevention (relative risk (RR) 0·59, 95% confidence intervals (CI) 0·40-0·89). Based on the results, we conducted a multicenter, double-blind, control trial to investigate whether 100mg diclofenac is superior than same-dose indomethacin. This trial planned to enroll 3612 patients in total. However, in the first interim analysis, PEP occurred in 53 patients (8.8%) of 600 patients allocated to diclofenac group and 37 patients (6.1%) of 604 patients allocated to indomethacin group (relative risk (RR) 1.44; 95% confidence interval (CI) 0.96-2.16, p=0.074). Thus, the trial was stopped according to the futility rule of conditional power. However, it was worth noticing that PEP tended to be higher in diclofenac group than that in indomethacin group. A sample size of 1204 was under power to draw the conclusion of significantly lower PEP rate in indomethacin group and thus a new trial with larger sample size of sufficient power is predicted to prove the superiority of indomethacin over diclofenac. Here we conducted a multicenter, randomized, double-blind trial to investigate whether 100mg indomethacin is superior to 100mg diclofenac in preventing PEP.

Being tested
Indomethacin 100 MG, Diclofenac 100mg
Medical subject headings
Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indomethacin 100 MGDrug

    All patients without contraindications should receive 100mg rectal indomethacin within 30mins before ERCP procedure

  • Diclofenac 100mgDrug

    All patients without contraindications should receive 100mg rectal diclofenac within 30mins before ERCP procedure

Study groups in NCT07071441
Study groupRoleWhat they receive
IndomethacinExperimentalAll patients without contraindications should receive 100mg rectal indomethacin within 30mins before ERCP procedure
Receives: Drug: Indomethacin 100 MG
Diclofenac groupActive comparatorAll patients without contraindications should receive 100mg rectal diclofenac within 30mins before ERCP procedure
Receives: Drug: Diclofenac 100mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of post-ERCP Pancreatitis

    a new or aggravated upper abdominal pain, with an elevated pancreatic enzyme of at least 3 times as the upper limit of normal value 24h after procedure and prolonged hospitalization days for at least 2 days. This definition was based on a widely recognized Cotton consensus

    Measured: 30 days

Secondary outcomes (8)
  1. Rate of mild, moderate or severe PEP

    The severity classification of post-ERCP pancreatitis was defined according to the Cotton Criteria. Mild PEP: with an extension of hospitalization period of 2-3 days; Moderate PEP: with an extension of hospitalization period of 4-10 days; Severe PEP: with an extension of more than 10 days, or hemorrhagic pancreatitis, phlegmon, or pseudocyst, intervention (percutaneous drainage or surgery), or death.

    Measured: 30 days

  2. Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria

    Mild: The most common form of acute pancreatitis, without organ failure or local or systemic complications, generally resolving within 1 week of onset.

    Moderately Severe: the presence of transient organ failure, local complications or exacerbation of co-morbid disease.

    Severe: persistent organ failure, that is, organ failure >48 h. Local complications are peripancreatic fluid collections, pancreatic and peripancreatic necrosis (sterile or infected), pseudocyst and walled-off necrosis (sterile or infected).

    Measured: 30 days

  3. Rate of ERCP-related perforation

    Perforation was established according to Cotton criteria, Mild: slight leakage of fluid or contrast dye, manageable through fluid administration and suction therapy ≤3 days Moderate: definite perforation required to be managed for 4-10 days Severe: management for more than 10 days or requiring for percutaneous or surgical intervention.

    Measured: 30 days

  4. Rate of ERCP-related infection

    Infection was established according to Cotton criteria. Mild: temperature >38℃ for 24-48h Moderate: Febrile illness requiring >3 days of hospital treatment; endoscopic or percutaneous interventions; Severe: septic shock or requiring surgery.

    Measured: 30 days

  5. Rate of ERCP-related bleeding

    Bleeding was established according to Cotton criteria. Mild: a documented decrease in hemoglobin concentration by <3 g/L, without requiring the blood transfusion; Moderate: blood transfusion ≤4 units; without need for angiographic or surgery interventions Severe: Transfusion: ≥5 units or requiring for angiographic or surgery interventions.

    Measured: 30 days

  6. Rate of NSAIDs-related complications

    NSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death

    Measured: 30 days

  7. Rate of mortality

    Measured: 30 days

  8. The rate of total adverse events

    Adverse events include ERCP-related or non ERCP-related adverse events

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2025
  2. Study start1 Jun 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,050 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07071441
Sponsor's protocol ID
KY20242439-F-1
Status last verified
Jun 2026
First submitted
8 Jul 2025
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Akshintala VS, Sperna Weiland CJ, Bhullar FA, Kamal A, Kanthasamy K, Kuo A, Tomasetti C, Gurakar M, Drenth JPH, Yadav D, Elmunzer BJ, Reddy DN, Goenka MK, Kochhar R, Kalloo AN, Khashab MA, van Geenen EJM, Singh VK. Non-steroidal anti-inflammatory drugs, intravenous fluids, pancreatic stents, or their combinations for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2021 Sep;6(9):733-742. doi: 10.1016/S2468-1253(21)00170-9. Epub 2021 Jun 30.

    PubMed 34214449
  • Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.

    PubMed 31863440
  • Kang X, Xia M, Wang J, Wang X, Luo H, Qin W, Liang Z, Zhao G, Yang L, Sun H, Tao J, Ning B, Zhong L, Zhang R, Ma X, Zhao J, Yue L, Jin H, Kang C, Ren G, Liang S, Wang H, Wang L, Nie Y, Wu K, Fan DM, Pan Y. Rectal diclofenac versus indomethacin for prevention of post-ERCP pancreatitis (DIPPP): a multicentre, double-blind, randomised, controlled trial. Gut. 2025 Jun 6;74(7):1094-1102. doi: 10.1136/gutjnl-2024-334466.

    PubMed 40113243
  • Luo 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

Questions about this trial

What is this clinical trial studying?

A study testing Indomethacin 100 MG and Diclofenac 100mg in people with ERCP and Pancreatitis, run by Air Force Military Medical University, China at 20 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 9 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanglin Pan, MD (86-84771536, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of 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 NCT07071441, which also lists 4 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 15 Jun 2026.

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