Clinical Trial

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

Study acronym: CORTIFRENCH
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2019-03-13; most recent amendment 2026-01-16.
Status change: Recruiting → Active, Not Recruiting 2024-09-24
Status change: Not Yet Recruiting → Recruiting 2019-07-04
Trial Details
NCT Number NCT03875690
Lead Sponsor Centre Hospitalier Universitaire Dijon
Conditions Elective Surgery for Any Digestive Cancer
Enrollment 1,200 participants
Start Date 2019-07-02
Primary Completion 2024-02-29 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-01-20