Elective Surgery for Any Digestive Cancer
Conditions
Brief 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.
Interventions
DRUGInjection of methylprednisolone
Patients will receive 20mg/kg IV of methylprednisolone at the time of anaesthetic induction. Methylprednisolone will be infused in a ready-to-use 50 mL bag of sodium chloride 0.9% during 30 minutes at anaesthesic induction.
DRUGInjection of sodium chloride
patients in the placebo group will receive 50 mL of sodium chloride 0.9% in a ready-to-use bag during 30 minutes at anaesthesic induction.
BIOLOGICALBlood samples
electrolyte panel and glycemia performed within the first 24 hours after surgery.
Sponsors
Centre Hospitalier Universitaire Dijon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>\_18 years * Elective surgery for any digestive cancer (except purely hepatic surgery) * Patients operated in a curative intent * Patients who had given their written informed consent * Patients affiliated to a National health insurance scheme
Exclusion criteria
* Emergency surgery * Pregnant or breastfeeding women * Patients with an ongoing oral treatment by steroids * Palliative surgery * Exclusive liver surgery * Concomitant hyperthermic intraperitoneal chemotherapy * Patient with at least one contra-indication to methylprednisolone treatment : * active infection * progressive/symptomatic viral infection (particularly hepatitis, herpes, chickenpox, herpes zoster) * uncontrolled psychotic state * hypersensitivity to methylprednisolone or to one of its excipients * ASA grade \>3 * Persons subject to a measure of legal protection (guardianship, tutorship) * Persons subject to a court order * Impossibility to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency of patients with postoperative major complications occurring within 30 days after surgery | Through study completion, an average of 5 years |
Countries
France
Outcome results
None listed