Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy

Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy - a Randomized Controlled Trial

Pancreatico-duodenectomy is one of the commonly performed procedure for periampullary/distal cholangio/head of pancreas carcinoma. Post operative pancreatitis is an emerging concept, recently being studied as one of the most important contributing factor of Post-operative pancreatic fistula, which is one of the major complication of pancreatoduodenectomy. Rectal indomethacin, a type of non-steroidal anti-inflammatory drug, when given in a single dose has been shown to prevent pancreatitis in patients undergoing ERCP. In this study, we will be administering rectal indomethacin at the time of induction of anesthesia to the experimental arm of the study and compare the results in terms of incidence of post-operative pancreatitis in the two groups.

Study Overview

• Status: Completed
• Conditions: Pancreatoduodenectomy
• Intervention / Treatment: Other: Standard Medical Treatment; Drug: Indomethacin suppository

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

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 consenting adults planned to undergo pancreatoduodenectomy,

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; 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 Indomethacin Suppository administered at the time of Induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-operative Pancreatitis	first 30 days following pancreatoduodenectomy

Secondary Outcome Measures

Outcome Measure	Time Frame
Post-operative Pancreatic Fistula	first 30 days following pancreatoduodenectomy
delayed gastric emptying	First 30 days following pancreatoduodenectomy
intra-abdominal abscess	first 30 days following pancreatoduodenectomy
Length of ICU stay	First 30 days following pancreatoduodenectomy
Length of hospital stay	First 30 days following pancretoduodenectomy
risk factors of post-operative pancreatitis	first 30 days following pancreatoduodenectomy

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Study Director: Viniyendra Pamecha, FEBS, Institute of Liver & Biliary Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2020
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ACTUAL): May 31, 2022

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (ACTUAL): November 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 3, 2022
• Last Verified: October 1, 2021

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: IEC/2020/81/MA13

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
• product manufactured in and exported from the U.S.: No