drugset / Trial / NCT07599605
Prophylaxis Against Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis.
RandomizedParallel-groupOpen-labelPrevention
Summary
Endoscopic retrograde cholangiopancreatography (ERCP) is a key procedure for managing biliopancreatic diseases, although it is associated with complications such as post-ERCP pancreatitis. This study assessed the efficacy of a prophylactic protocol combining rectal indomethacin with aggressive hydration to reduce the incidence of post-ERCP pancreatitis and serum amylase and lipase levels.
Timeline
- Start
- 2024-03-04
- Primary completion
- 2024-12-27
- Completion
- 2025-01-17
Publications
- Background Aghajanpoor Pasha M, Eslami P, Dooghaie Moghadam A, Moazzami B, Shojaee S, Almasi F, Tavakolikia N, Norouzinia M, Radinnia E, Sadeghi A. The synergistic impact of NSAIDs and aggressive hydration therapy on the rate of post-ERCP pancreatitis in high -risk and low -risk patients. Gastroenterol Hepatol Bed Bench. 2020 Winter;13(Suppl1):S81-S88.
- Background Aljohani S, Mirghani H. Aggressive Hydration With Ringer's Lactate in the Prevention of Post-ERCP Pancreatitis: A Meta-Analysis. Cureus. 2021 May 7;13(5):e14897. doi: 10.7759/cureus.14897.
- Background Wan J, Ren Y, Zhu Z, Xia L, Lu N. How to select patients and timing for rectal indomethacin to prevent post-ERCP pancreatitis: a systematic review and meta-analysis. BMC Gastroenterol. 2017 Mar 15;17(1):43. doi: 10.1186/s12876-017-0599-4.
- Background Goyal H, Sachdeva S, Sherazi SAA, Gupta S, Perisetti A, Ali A, Chandan S, Tharian B, Sharma N, Thosani N. Early prediction of post-ERCP pancreatitis by post-procedure amylase and lipase levels: A systematic review and meta-analysis. Endosc Int Open. 2022 Jul 15;10(7):E952-E970. doi: 10.1055/a-1793-9508. eCollection 2022 Jul.
- Background Cahyadi O, Tehami N, de-Madaria E, Siau K. Post-ERCP Pancreatitis: Prevention, Diagnosis and Management. Medicina (Kaunas). 2022 Sep 12;58(9):1261. doi: 10.3390/medicina58091261.
- Background Easler JJ, Fogel EL. Prevention of post-ERCP pancreatitis: the search continues. Lancet Gastroenterol Hepatol. 2021 May;6(5):336-337. doi: 10.1016/S2468-1253(21)00063-7. Epub 2021 Mar 19. No abstract available.
- Background Borrelli de Andreis F, Mascagni P, Schepis T, Attili F, Tringali A, Costamagna G, Boskoski I. Prevention of post-ERCP pancreatitis: current strategies and novel perspectives. Ther Adv Gastroenterol. 2023 Mar 6;16:17562848231155984. doi: 10.1177/17562848231155984. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indomethacin | Small molecule | 100 mg | — |