Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection

Phase 2 Completed Tampere University Hospital

Summary

The purpose of this randomized, placebo-controlled trial is to investigate whether postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy or distal pancreatic resection may be reduced with cortisone treatment. Treatment is administered to high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).

Timeline

Start: 2011-02
Primary completion: 2017-01
Completion: 2017-01

Outcome

Mixed primary results

paper Hydrocortisone treatment did not alter trypsinogen release (2 or more positive days 46% vs 50%), PMID 27429037 ↗

paper but it significantly reduced overall complications compared with placebo in the high-risk patients (18% vs 41%; P < 0.05; Clavien-Dindo III-IV). PMID 27429037 ↗

Publications

Laaninen M, Sand J, Nordback I, Vasama K, Laukkarinen J. Perioperative Hydrocortisone Reduces Major Complications After Pancreaticoduodenectomy: A Randomized Controlled Trial. Ann Surg. 2016 Nov;264(5):696-702. doi: 10.1097/SLA.0000000000001883.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydrocortisone	Other / unclassified	100 mg	Intravenous