Clinical trial NCT03547232: Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)
Official title: Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial): Study Protocol for a Multi-center, Double-blinded, Placebo-controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Pancreatitis
Complication
Mortality Rate
Organ Failure, Multiple
Keywords: Acute pancreatitis
Indomethacin
Prognosis
Organ dysfunction
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 1504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* All patients ages 18-80 years with a diagnosis of AP based on at least 2 of the following criteria:
* Abdominal pain characteristic of AP
* Serum amylase and/or lipase ≥ 3 times the upper limit of normal
* Characteristic findings of AP on abdominal CT scan will be screened for study enrollment.

Exclusion Criteria:

* Onset time \>24 hours
* Presence of renal dysfunction (serum creatinine \> 1.5 \*normal upper limit)
* Severe liver dysfunction
* Active peptic ulcer disease or GI bleeding
* Pregnancy or breast-feeding
* Hypersensitivity to NSAIDs
* New-onset, exacerbation or uncontrolled hypertension
* Presence of serious cardiovascular events, including severe heart failure, myocardial infarction (MI) and stroke
* Mental disability
* Malignancy-associated acute pancreatitis
* Post-ERCP pancreatitis
* Informed consent not signed

Primary outcomes:
measure: Occurence rate of organ dysfunction caused by acute pancreatitis
timeFrame: 1 week
Secondary outcomes:
measure: Occurence rate of pancreatic necrosis
timeFrame: 1 month
measure: Incidence rate of ICU admission
timeFrame: 1 month
measure: Mortality
timeFrame: 1 month
Other outcomes:
measure: Hospitalization cost
timeFrame: 1 month
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Liangxiang Hospital
state: Beijing
city: Guiyang
country: China
facility: Guiyang Second People's Hospital
state: Guizhou
city: Baoding
country: China
facility: Baoding Seventh Hospital
state: Hebei
city: Harbin
country: China
facility: Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Dengzhou
country: China
facility: Dengzhou People's Hospital
state: Henan
city: Nanyang
country: China
facility: Second People Hospital of Nanyang
state: Henan
city: Huaian
country: China
facility: The Second People's Hospital of Huai'an
state: Jiangsu
city: Nantong
country: China
facility: Nantong First People's Hospital
state: Jiangsu
city: Suqian
country: China
facility: Suqian People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Third People's Hospital
state: Jiangsu
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
city: Chengdu
country: China
facility: West China Longquan Hospital Sichuan University
state: Sichuan
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui Municipal Central Hospital
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Dong Wu, M.D.
role: STUDY_CHAIR
affiliation: Baoding Seventh Hospital
name: Zhitao Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Liangxiang Hospital
name: Yanfeng Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Guiyang Second People's Hospital
name: Shanshan Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dengzhou People's Hospital
name: Na Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Qinghai University
name: Mei Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Second People Hospital of Nanyang
name: Xiao Fan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Sixth Hospital
name: Zuoyan Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harbin Medical University
name: Ruifeng Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantong First People's Hospital
name: Baofeng Zhu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second People's Hospital of Huai'an
name: Yan Shi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Suqian People's Hospital
name: Ming Sun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuxi Third People's Hospital
name: Wei Huang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Longquan Hospital Sichuan University
name: Shicheng Zheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Jianzhong Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinhua Municipal Central Hospital
name: Daoyuan Jing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lishui Municipal Central Hospital
name: Hong Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.