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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Recruiting
CT.gov ID
NCT03875690
Collaborator
(none)
1,200
1
2
86
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Injection of methylprednisolone
  • Drug: Injection of sodium chloride
  • Biological: Blood samples
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial
Actual Study Start Date :
Jul 2, 2019
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

Drug: 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.

Biological: Blood samples
electrolyte panel and glycemia performed within the first 24 hours after surgery.

Placebo Comparator: Control group

Drug: 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.

Biological: Blood samples
electrolyte panel and glycemia performed within the first 24 hours after surgery.

Outcome Measures

Primary Outcome Measures

  1. frequency of patients with postoperative major complications occurring within 30 days after surgery [Through study completion, an average of 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

  • on course viral disease (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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu de Dijon Dijon France 21079

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT03875690
Other Study ID Numbers:
  • ORTEGA PHRCK 2017
First Posted:
Mar 15, 2019
Last Update Posted:
Feb 22, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 22, 2022