Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis

Study Overview
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Brief Summary
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Acute pancreatitis is a common critical disease of the digestive system. Accumulated data showed that overexpression of cyclooxygenase-2 (COX-2) in acute pancreatitis and experimental pancreatitis could be attenuated with COX-2 inhibitors. In recent years, it has been found that timely administration of indomethacin or diclofenac sodium to anus after ERCP can significantly reduce the incidence of AP after ERCP in patients at high risk of AP. The aim of this study was to evaluate the efficacy of rectal indomethacin in reducing the systemic inflammatory response syndrome (SIRS) score in AP patients.

Official Title
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Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis

Conditions
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Acute Pancreatitis, Systemic Inflammatory Response Syndrome

Intervention / Treatment
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* Drug: Indometacin
* Other: conventional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (i) either gender aged 18-70 years; (ii) a confirmed diagnosis of AP; (iii) the time interval from the onset of symptoms to admission was no more than 48 h; (iv) written informed consent was obtained from the patients or their legal representatives. Exclusion Criteria: (i) pregnancy and breast feeding mother; (ii) severe chronic diseases such as cardiac dysfunction, chronic obstructive pulmonary disease, renal insufficiency, cirrhosis, inflammatory bowel diseases, and malignancies; (iii) peptic ulcer; (iv) pancreatitis due to trauma; (v) drug allergy; (vi) drug abuse and psychosis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: convention<br>patients in convention arm receive conventional management according to AP guidelines of International Association of Pancreatology and the Chinese Society of Gastroenterology, including goal-directed fluid resuscitation, oxygen supply even mechanical ventilation, and nutritional support if necessary. | Other: conventional treatment<br>* All enrolled patients received conventional management according to AP guidelines of International Association of Pancreatology and the Chinese Society of Gastroenterology, including goal-directed fluid resuscitation, oxygen supply even mechanical ventilation, and nutritional support if necessary.<br>* Other names: convention;|
| Experimental: convention + indometacin<br>Besides the conventional treatment,patients in convention + indometacin arm receive 50-mg indomethacin suppositories at intervals of 12 hours for a total of 6 doses. | Drug: Indometacin<br>* Besides the conventional treatment, indomethacin will be given to the patients in the convention + indomethacin group.<br>* Other names: convention + indometacin;Other: conventional treatment<br>* All enrolled patients received conventional management according to AP guidelines of International Association of Pancreatology and the Chinese Society of Gastroenterology, including goal-directed fluid resuscitation, oxygen supply even mechanical ventilation, and nutritional support if necessary.<br>* Other names: convention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic inflammatory response syndrome(SIRS) score at 72 hours after the initial intervention. | The minimum value of SIRS is 0, and the maximum value of SIRS is 4. The higher score means a worse outcome. | 72 hours after the initial intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the serum levels of C-reactive protein(CRP) | The normal range of CRP is 0-10mg/L, and the higher value means a worse outcome. | 72 hours after the initial intervention. | 
| the serum levels of interleukin-6(IL-6) | The normal range of IL-6 is 0-7pg/ml, and the higher value means a worse outcome. | 72 hours after the initial intervention. | 
| score of abdominal pain | The range of score of abdominal pain is 0-10, and the higher value means a worse outcome. | 72 hours after the initial intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-steroidal anti-inflammatory drugs, indomethacin