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

NCT03875690 | Active Not Recruiting Phase 3

• 1 other identifier: ORTEGA PHRCK 2017
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Elective Surgery for Any Digestive Cancer

Outcome Measures

Primary Outcomes (1)

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

  Through study completion, an average of 5 years

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: Injection of methylprednisolone; Biological: Blood samples

Control group

PLACEBO COMPARATOR

Drug: Injection of sodium chloride; Biological: Blood samples

Interventions

Injection of methylprednisolone DRUG

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.

Experimental group

Injection of sodium chloride DRUG

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.

Control group

Blood samples BIOLOGICAL

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

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu de Dijon

Dijon, 21079, France

Location

Related Publications (1)

• Magnin J, Fournel I, Doussot A, Regimbeau JM, Zerbib P, Piessen G, Beyer-Berjot L, Deguelte S, Lakkis Z, Schwarz L, Orry D, Ayav A, Muscari F, Mauvais F, Passot G, Trelles N, Venara A, Benoist S, Messager M, Fuks D, Borraccino B, Tresallet C, Valverde A, Souche FR, Herrero A, Gaujoux S, Lefevre J, Bourredjem A, Cransac A, Ortega-Deballon P. Benefit of a flash dose of corticosteroids in digestive surgical oncology: a multicenter, randomized, double blind, placebo-controlled trial (CORTIFRENCH). BMC Cancer. 2022 Aug 23;22(1):913. doi: 10.1186/s12885-022-09998-z.

  PMID: 35999521 DERIVED

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: July 2, 2019
• Primary Completion: February 29, 2024
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

FR (1)