Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2020
CompletedFirst Submitted
Initial submission to the registry
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
November 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedJuly 6, 2022
October 1, 2021
1.5 years
October 26, 2021
July 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative Pancreatitis
first 30 days following pancreatoduodenectomy
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Group B
ACTIVE COMPARATORStandard Medical Treatment
Group A
EXPERIMENTALWill be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment
Interventions
100mg Indomethacin Suppository administered at the time of Induction
Eligibility Criteria
You may qualify if:
- All consenting adults planned to undergo pancreatoduodenectomy,
You may not qualify if:
- asthma
- allergic reactions to NSAIDs
- CKD
- internal hemorrhoids
- anti-platelet medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Study Officials
- STUDY DIRECTOR
Viniyendra Pamecha, FEBS
Institute of Liver & Biliary Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2021
First Posted
November 5, 2021
Study Start
October 17, 2020
Primary Completion
April 30, 2022
Study Completion
May 31, 2022
Last Updated
July 6, 2022
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share