Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis

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.

Study Overview

• Status: Recruiting
• Conditions: Systemic Inflammatory Response Syndrome; Acute Pancreatitis
• Intervention / Treatment: Other: conventional treatment; Drug: Indometacin

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuahua Han; Phone Number: +86 0571 89713734; Email: hanyaohua@zju.edu.cn
• Study Contact Backup: Name: Gangzhi Zhang; Phone Number: +8613588153610; Email: arbend@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310005
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: yuehua han; Phone Number: +86 0571 89713734; Email: hanyaohua@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: convention; 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; 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.; Other Names: convention
Experimental: convention + indometacin; 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.	Other: conventional treatment; 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.; Other Names: convention; Drug: Indometacin; Besides the conventional treatment, indomethacin will be given to the patients in the convention + indomethacin group.; Other Names: convention + indometacin

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2022
• Primary Completion (Anticipated): December 11, 2023
• Study Completion (Anticipated): December 11, 2023

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: indomethacin; Non-steroidal anti-inflammatory drugs
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Inflammation; Shock; Pancreatic Diseases; Pancreatitis; Systemic Inflammatory Response Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Indomethacin
• Other Study ID Numbers: IR2022467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No