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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin | Experimental | All patients without contraindications should receive 100mg rectal indomethacin within 30mins before ERCP procedure |
|
| Diclofenac group | Active Comparator | All patients without contraindications should receive 100mg rectal diclofenac within 30mins before ERCP procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin 100 MG | Drug | All patients without contraindications should receive 100mg rectal indomethacin within 30mins before ERCP procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanglin Pan, MD | Contact | 86-84771536 | yanglinpan@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first medical center, Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34214449 | Background | 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. | |
| 31863440 |
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| Diclofenac 100mg | Drug | All patients without contraindications should receive 100mg rectal diclofenac within 30mins before ERCP procedure |
|
| 30 days |
| 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). | 30 days |
| 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. | 30 days |
| 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. | 30 days |
| 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. | 30 days |
| Rate of NSAIDs-related complications | NSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death | 30 days |
| Rate of mortality | 30 days |
| The rate of total adverse events | Adverse events include ERCP-related or non ERCP-related adverse events | 30 days |
| The Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 404100 | China |
|
| Department of Gastroenterology, Hongai Hospital | Recruiting | Xiamen | Fujian | 361000 | China |
|
| Harbin Medical University Affiliated Fourth Hospital | Recruiting | Harbin | Heilongjiang | 150000 | China |
|
| Zhaolei181220@163.Com | Recruiting | Harbin | Heilongjiang | 150000 | China |
|
| Huaihe Hospital of Henan University | Recruiting | Kaifeng | Hennan | 475000 | China |
|
| Renmin hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430000 | China |
|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430000 | China |
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| The Third Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410000 | China |
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| Jilin Miniciple People'S Hospital | Recruiting | Jilin City | Jilin | 132000 | China |
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| Qinghai University Affiliated Hospital | Recruiting | Xining | Qinghai | 810000 | China |
|
| 986 Hospital of Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710000 | China |
|
| Second Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710000 | China |
|
| Xijing Hospital of Digestive Diseases | Recruiting | Xi'an | Shaanxi | 710000 | China |
| Shandong Provincial Third Hospital | Not yet recruiting | Jinan | Shandong | 250000 | China |
|
| The 960th Hospital of the PLA | Recruiting | Jinan | Shandong | 250000 | China |
|
| Eastern Hepatobiliary Surgery Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| Affiliated Hangzhou First People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| the First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| the second Affiliated Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| Background |
| 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. |
| 40113243 | Background | 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. |
| 27133971 | Background | 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. |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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