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

Study Overview
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Brief Summary
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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.

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

Conditions
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Elective Surgery for Any Digestive Cancer

Intervention / Treatment
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* Drug: Injection of methylprednisolone
* Drug: Injection of sodium chloride
* Biological: Blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Drug: Injection of methylprednisolone<br>* 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.<br>Biological: Blood samples<br>* electrolyte panel and glycemia performed within the first 24 hours after surgery.<br>|
| Placebo Comparator: Control group<br> | Drug: Injection of sodium chloride<br>* 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.<br>Biological: Blood samples<br>* electrolyte panel and glycemia performed within the first 24 hours after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of patients with postoperative major complications occurring within 30 days after surgery |  | Through study completion, an average of 5 years |