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

Primary Purpose

Pancreatoduodenectomy

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Indomethacin suppository
Standard Medical Treatment
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatoduodenectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All consenting adults planned to undergo pancreatoduodenectomy,

Exclusion Criteria:

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

Sites / Locations

  • Institute of Liver & Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group B

Group A

Arm Description

Standard Medical Treatment

Will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment

Outcomes

Primary Outcome Measures

Post-operative Pancreatitis

Secondary Outcome Measures

Post-operative Pancreatic Fistula
delayed gastric emptying
intra-abdominal abscess
Length of ICU stay
Length of hospital stay
risk factors of post-operative pancreatitis

Full Information

First Posted
October 26, 2021
Last Updated
July 3, 2022
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT05109143
Brief Title
Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy
Official Title
Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 17, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatoduodenectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Standard Medical Treatment
Arm Title
Group A
Arm Type
Experimental
Arm Description
Will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment
Intervention Type
Drug
Intervention Name(s)
Indomethacin suppository
Intervention Description
100mg Indomethacin Suppository administered at the time of Induction
Intervention Type
Other
Intervention Name(s)
Standard Medical Treatment
Intervention Description
Standard Medical Treatment
Primary Outcome Measure Information:
Title
Post-operative Pancreatitis
Time Frame
first 30 days following pancreatoduodenectomy
Secondary Outcome Measure Information:
Title
Post-operative Pancreatic Fistula
Time Frame
first 30 days following pancreatoduodenectomy
Title
delayed gastric emptying
Time Frame
First 30 days following pancreatoduodenectomy
Title
intra-abdominal abscess
Time Frame
first 30 days following pancreatoduodenectomy
Title
Length of ICU stay
Time Frame
First 30 days following pancreatoduodenectomy
Title
Length of hospital stay
Time Frame
First 30 days following pancretoduodenectomy
Title
risk factors of post-operative pancreatitis
Time Frame
first 30 days following pancreatoduodenectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All consenting adults planned to undergo pancreatoduodenectomy, Exclusion Criteria: asthma allergic reactions to NSAIDs CKD internal hemorrhoids anti-platelet medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viniyendra Pamecha, FEBS
Organizational Affiliation
Institute of Liver & Biliary Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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