drugset / Trial / NCT03875690

Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial

NCT03875690

Phase 3 Active not recruiting 1200 enrolled Centre Hospitalier Universitaire Dijon
RandomizedParallel-groupSingle-blindTreatment

Summary

Perioperative inflammation is harmful in cancer patients, namely in those undergoing surgery: it increases the risk of recurrence, decreases cancer survival, increases post-operative complications, and prolongs the time of recovery and the duration of hospital stay. Severe postoperative complications are also a risk factor of poor survival in cancer patients. Seemingly, some effective therapies currently used to improve the surgical outcome (e.g. immunonutrition, enhanced-recovery protocols) have an inflammatory effect. The modulation of perioperative inflammation therefore seems crucial to improve outcomes in patients undergoing surgery for digestive cancer. A short perioperative treatment with high doses of corticosteroids has already been tested in several randomized trials. A recent meta-analysis showed that perioperative corticosteroids decreased inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery: the decrease in the risk of postoperative complications was around 50% without adverse effects.

Timeline

Start
2019-07-02
Primary completion
2024-02-29
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified 20 mg/kg Intravenous

Indications

No indication recorded.