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Acute pancreatitis (AP) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. The production and release of inflammatory factors is generally considered as the key factor of pathogenesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly applied agents for inflammatory diseases. A series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ERCP), but high-quality evidence is still lacking in the field of effectiveness of NSAIDs to treat, rather than prevent, other types of AP. Majority of animal experiments showed that NSAIDs had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. Randomized controlled trials are eagerly awaited to elucidate its effects on AP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin group | Experimental | Indomethacin SR 50mg q12h from day1 to day 7 plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible. |
|
| Standard group | Sham Comparator | Similar shape and size suppositories without indomethacin (Placebos) given q12h from admission day 1 to day 7, plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin SR | Drug | Indomethacin SR 50mg given q12h from admission day 1 to day 7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurence rate of organ dysfunction caused by acute pancreatitis | Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence rate of pancreatic necrosis | Accumulation of the key local complication of acute pancreatitis | 1 month |
| Incidence rate of ICU admission | Evaluation of critical severe acute pancreatitis |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization cost | Expense of acute pancreatitis | 1 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Wu, M.D. | Contact | 8618612671010 | dongwu@pumc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dong Wu, M.D. | Peking Union Medical College Hospital | Study Chair |
| Zhitao Lu, M.D. | Baoding Seventh Hospital | Principal Investigator |
| Yanfeng Wang, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Sixth Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25872171 | Result | Gorsky VA, Agapov MA, Khoreva MV, Leonenko IV. The effect of lornoxicam on TLR2 and TLR4 messenger RNA expression and tumor necrosis factor-alpha, interleukin-6, and interleukin-8 secretion in patients with systemic complications of acute pancreatitis. Pancreas. 2015 Jul;44(5):824-30. doi: 10.1097/MPA.0000000000000344. |
| Label | URL |
|---|---|
| A small sample study of NSAIDs for treatment of acute pancreatitis | View source |
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| Placebos | Drug | Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7 |
|
|
| 1 month |
| Mortality | The number of deaths during a particular period of time | 1 month |
| Liangxiang Hospital |
| Principal Investigator |
| Shanshan Yu, M.D. | Guiyang Second People's Hospital | Principal Investigator |
| Na Wu, M.D. | Dengzhou People's Hospital | Principal Investigator |
| Mei Liu, M.D. | Affiliated Hospital of Qinghai University | Principal Investigator |
| Xiao Fan, M.D. | Second People Hospital of Nanyang | Principal Investigator |
| Zuoyan Wu, MD | Peking University Sixth Hospital | Principal Investigator |
| Ruifeng Wang, MD | Harbin Medical University | Principal Investigator |
| Baofeng Zhu, MD | Nantong First People's Hospital | Principal Investigator |
| Yan Shi, MD | The Second People's Hospital of Huai'an | Principal Investigator |
| Ming Sun, MD | Suqian People's Hospital | Principal Investigator |
| Wei Huang, MD | Wuxi Third People's Hospital | Principal Investigator |
| Shicheng Zheng, MD | West China Longquan Hospital Sichuan University | Principal Investigator |
| Jianzhong Yang, MD | First Affiliated Hospital of Xinjiang Medical University | Principal Investigator |
| Daoyuan Jing, MD | Jinhua Municipal Central Hospital | Principal Investigator |
| Hong Liu, MD | Lishui Municipal Central Hospital | Principal Investigator |
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
|
| Liangxiang Hospital | Recruiting | Beijing | Beijing Municipality | 102401 | China |
|
| Guiyang Second People's Hospital | Recruiting | Guiyang | Guizhou | 550005 | China |
|
| Baoding Seventh Hospital | Recruiting | Baoding | Hebei | 071000 | China |
|
| Fourth Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150001 | China |
|
| Dengzhou People's Hospital | Recruiting | Dengzhou | Henan | 411381 | China |
|
| Second People Hospital of Nanyang | Recruiting | Nanyang | Henan | 473012 | China |
|
| The Second People's Hospital of Huai'an | Recruiting | Huaian | Jiangsu | 223300 | China |
|
| Nantong First People's Hospital | Recruiting | Nantong | Jiangsu | 226001 | China |
|
| Suqian People's Hospital | Recruiting | Suqian | Jiangsu | 223800 | China |
|
| Wuxi Third People's Hospital | Recruiting | Wuxi | Jiangsu | 214043 | China |
|
| Qinghai University Affiliated Hospital | Recruiting | Xining | Qinghai | 810001 | China |
|
| West China Longquan Hospital Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | 830054 | China |
|
| Jinhua Municipal Central Hospital | Recruiting | Jinhua | Zhejiang | 321000 | China |
|
| Lishui Municipal Central Hospital | Recruiting | Lishui | Zhejiang | 323000 | China |
|
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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