Clinical trial

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

Name

ORTEGA PHRCK 2017

Description

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.

Trial arms

Trial start

2019-07-02

Estimated PCD

2027-04-01

Trial end

2027-09-01

Status

Recruiting

Phase

Early phase I

Treatment

Injection 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.

Arms:

Experimental group

Injection 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.

Arms:

Control group

Blood samples

electrolyte panel and glycemia performed within the first 24 hours after surgery.

Arms:

Control group, Experimental group

Size

1200

Primary endpoint

frequency of patients with postoperative major complications occurring within 30 days after surgery

Through study completion, an average of 5 years

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1200, 'type': 'ESTIMATED'}}

Updated at

2023-10-23

1 organization

3 products

1 indication

Organization

Centre Hospitalier Universitaire Dijon

Product

Indication

Product

Product