Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637281
• Other study ID #: IR2022467
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2022
• Est. completion date: December 11, 2023

Study information

• Verified date: November 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yuahua Han
• Phone: +86 0571 89713734
• Email: hanyaohua[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis
• Systemic Inflammatory Response Syndrome

Intervention

Drug:
• Indometacin
Besides the conventional treatment, indomethacin will be given to the patients in the convention + indomethacin group.

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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.