Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT03547232

Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)

Led by Peking Union Medical College Hospital · Updated on 2025-06-15

1504

Participants Needed

17

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 80 years
  • Diagnosis of acute pancreatitis confirmed by at least two of the following: characteristic abdominal pain, serum amylase or lipase three times above normal, or typical CT scan findings
Not Eligible

You will not qualify if you...

  • Onset of symptoms more than 24 hours prior
  • Renal dysfunction with serum creatinine above 1.5 times the normal upper limit
  • Severe liver dysfunction
  • Active peptic ulcer disease or gastrointestinal bleeding
  • Pregnancy or breastfeeding
  • Allergy or hypersensitivity to NSAIDs
  • New or uncontrolled high blood pressure
  • Serious cardiovascular events such as severe heart failure, myocardial infarction, or stroke
  • Mental disability
  • Acute pancreatitis caused by cancer
  • Pancreatitis following ERCP procedure
  • Lack of signed informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Peking University Sixth Hospital

Beijing, Beijing Municipality, China, 100191

Actively Recruiting

2

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

3

Liangxiang Hospital

Beijing, Beijing Municipality, China, 102401

Actively Recruiting

4

Guiyang Second People's Hospital

Guiyang, Guizhou, China, 550005

Actively Recruiting

5

Baoding Seventh Hospital

Baoding, Hebei, China, 071000

Actively Recruiting

6

Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150001

Actively Recruiting

7

Dengzhou People's Hospital

Dengzhou, Henan, China, 411381

Actively Recruiting

8

Second People Hospital of Nanyang

Nanyang, Henan, China, 473012

Actively Recruiting

9

The Second People's Hospital of Huai'an

Huaian, Jiangsu, China, 223300

Actively Recruiting

10

Nantong First People's Hospital

Nantong, Jiangsu, China, 226001

Actively Recruiting

11

Suqian People's Hospital

Suqian, Jiangsu, China, 223800

Actively Recruiting

12

Wuxi Third People's Hospital

Wuxi, Jiangsu, China, 214043

Actively Recruiting

13

Qinghai University Affiliated Hospital

Xining, Qinghai, China, 810001

Actively Recruiting

14

West China Longquan Hospital Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

15

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China, 830054

Actively Recruiting

16

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China, 321000

Actively Recruiting

17

Lishui Municipal Central Hospital

Lishui, Zhejiang, China, 323000

Actively Recruiting

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Research Team

D

Dong Wu, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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