Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis

Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis-A Randomized Controlled Trial

The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatectomy
• Intervention / Treatment: Other: Standard Medical Treatment; Drug: Indomethacin suppository

Detailed Description

The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

*All patients planned to undergo pancreatectomy.

Exclusion Criteria:

• asthma
• allergic reactions to NSAIDs
• CKD
• internal hemorrhoids
• anti-platelet medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group B; Standard Medical Treatment	Other: Standard Medical Treatment; Standard Medical Treatment
EXPERIMENTAL: Group A; Patients will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment	Other: Standard Medical Treatment; Standard Medical Treatment; Drug: Indomethacin suppository; 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-pancreatectomy Acute Pancreatitis	2 weeks after pancreatectomy

Secondary Outcome Measures

Outcome Measure	Time Frame
Pancreatic Fistula	30 days after pancreatectomy
Peripancreatic abscess	30 days after pancreatectomy
Length of hospital stay	30 days after pancreatectomy

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Yingbin Liu, PhD, Renji Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): February 1, 2024

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 10, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; 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: LYBWWG2023

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