Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis

Second Affiliated Hospital, School of Medicine, Zhejiang University188 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

188

Conditions

Acute Pancreatitis Systemic Inflammatory Response Syndrome

Interventions

conventional treatmentOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 72 hours after the initial intervention.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 72 hours after the initial intervention.

Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts