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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Completed

CT.gov ID

NCT05109143

Collaborator

(none)

Enrollment

Location

Arms

19.4

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatoduodenectomy	Drug: Indomethacin suppository Other: Standard Medical Treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 17, 2020

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

May 31, 2022

Arms and Interventions

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	Drug: Indomethacin suppository 100mg Indomethacin Suppository administered at the time of Induction Other: Standard Medical Treatment Standard Medical Treatment

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

Drug: Indomethacin suppository

100mg Indomethacin Suppository administered at the time of Induction

Other: Standard Medical Treatment

Standard Medical Treatment

Outcome Measures

Primary Outcome Measures

Post-operative Pancreatitis [first 30 days following pancreatoduodenectomy]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All consenting adults planned to undergo pancreatoduodenectomy,

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver & Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

Study Director: Viniyendra Pamecha, FEBS, Institute of Liver & Biliary Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT05109143

Other Study ID Numbers:

IEC/2020/81/MA13

First Posted:

Nov 5, 2021

Last Update Posted:

Jul 6, 2022

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pancreatitis

Indomethacin

Study Results

No Results Posted as of Jul 6, 2022