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

NCT05109143 | Completed

• 1 other identifier: IEC/2020/81/MA13
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 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.

Conditions

Pancreatoduodenectomy

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

Study Arms (2)

Group B

ACTIVE COMPARATOR

Standard Medical Treatment

Other: Standard Medical Treatment

Group A

EXPERIMENTAL

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

Drug: Indomethacin suppository; Other: Standard Medical Treatment

Interventions

Indomethacin suppository DRUG

100mg Indomethacin Suppository administered at the time of Induction

Group A

Standard Medical Treatment OTHER

Standard Medical Treatment

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Study Officials

• Viniyendra Pamecha, FEBS

  Institute of Liver & Biliary Sciences

  STUDY DIRECTOR

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

Locations

IN (1)