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NCT05109143
Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy
NA trial testing Indomethacin suppository in Pancreatoduodenectomy in 44 participants. Completed in 31 May 2022.
30 April 2022
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 44 |
| Start date | 17 October 2020 |
| Primary completion | 30 April 2022 |
| Estimated completion | 31 May 2022 |
| Sites | 1 location across India |
Drugs / interventions tested
- Indomethacin suppository — full drug profile →
- Standard Medical Treatment — full drug profile →
Conditions studied
- Pancreatoduodenectomy — all drugs for Pancreatoduodenectomy →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 80, any sex, with Pancreatoduodenectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05109143
- Europe PMC full search
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Related trials
Other trials of Indomethacin suppository
Trials testing the same drug.
- NCT06623513 — Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis · Phase 2 · not yet recruiting
- NCT05722548 — Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis · Phase 2 · unknown
- NCT05381428 — Prophylaxis of Post-ERCP Acute Pancreatitis · Phase 3 · completed
- NCT04964180 — Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy · NA · completed
Other recruiting trials for Pancreatoduodenectomy
Currently open trials in the same condition.
- NCT06953193 — Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia · NA · recruiting
- NCT06283160 — METabolomic and Immune PROfiling in the Development of Pancreatic Fistulas After cepHalic duodEnopancreatectomy · recruiting
Other Institute of Liver and Biliary Sciences, India trials
Trials by the same sponsor.
- NCT07480005 — To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies · recruiting
- NCT07480057 — Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry · recruiting
- NCT07465471 — Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis. · NA · not yet recruiting
- NCT07433881 — Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis · not yet recruiting
- NCT07422948 — Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05109143 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 6 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05109143.
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