Efficacy of Peri Operative Hydrocortisone and Indomethacin Treatment in Reducing Major Complications after Whipple's Pancreaticoduodenectomy, Randomized Controlled Clinical Trial

Introduction: Post Whipple's Pancreatico-duodenectomy (PD) the major concern is pancreaticojejunostomy (PJ) leak which leads to post operative pancreatic fistula (POPF), pancreatectomy haemorrhage(PPH), delayed gastric emptying (DGE) ,sepsis. sometimes mortality.Hydrocortisone and indomethacin have been postulated reduce pancreatitis thus PJ leak. Methods: Between Jan 2018 - April 2019, 146 patients for PD were included. Only high risk patient (n= 105)with >40% of acini (marker soft pancreas) on frozen section transection margin randomized intravenous (iv) hydrocortisone, per rectal (PR) or placebo (3 groups ,35 in each group). All received total 8 doses iv treatment (8 hourly) 6 PR (12 hourly). 100 ml NS glycerin suppository drugs. Primary end-points overall complications(Clavien Dindo 2-5). Results: Hydrocortisone group had less complications compared placebo(overall 14.3% vs 40.0%; P value = 0.003). POPF (8.6% 20%) DGE (14.3% 22.9%) also lower hydrocortisone Indomethacin did not (overall, 37.2% 40%; p 1.00). (17.1% PPH (11.4% 14.3%) Although, significantly 22.9%; 0.001). 30 day mortality was zero all groups. Conclusions: reduces postoperative after whereas does as placebo.