Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis

Not Applicable

Recruiting

• Conditions: Systemic Inflammatory Response Syndrome; Acute Pancreatitis
• Interventions: Other: conventional treatment; Drug: Indometacin

• Registration Number: NCT05637281
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-24
• Study First Posted: 2022-12-05
• Study Start: 2022-12-11
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-17
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
convention	conventional treatment	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.
convention + indometacin	conventional treatment	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.
convention + indometacin	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.

Primary Outcome Measures

Name	Time	Method
Systemic inflammatory response syndrome(SIRS) score at 72 hours after the initial intervention.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China