Benefit of a flash dose of corticosteroids in digestive surgical oncology: a randomized, double blind, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004852-39-FR

Enrollment

1200

Registered

2019-03-14

Start date

2019-03-12

Completion date

Unknown

Last updated

2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: méthylprednisolone Pharmaceutical Form: Powder for solution for injection Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years - Undergoing elective surgery for a 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Emergency surgery - Pregnant or breastfeeding women - Patients with an ongoing oral treatment by steroids - Palliative surgery - Exclusive liver surgery - Colorectal resection with 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 excipient - ASA grade >3 - Persons subject to a measure of legal protection (guardianship, tutorship) - Persons subject to a court order - Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the impact of a flash dose of preoperative corticosteroids versus placebo on the onset of major complications (Clavien-Dindo >2) within 30 days after elective curative-intent surgery for digestive cancer.;Secondary Objective: 1. EFFICACY: to assess the effect of a perioperatoive flash of corticosteroids versus placebo on : - Overall survival at 3 years - Disease-free survival at 3 years - Postoperative infections at D30 - Intraabdominal infections at D30 - Hospital stay duration 2. SAFETY : to assess the safety of perioperative flash of corticosteroids.;Primary end point(s): Frequency of patients with major postoperative complications, occurring within 30 days after surgery (D30) and defined as all complications with Clavien-Dindo grade>2.;Timepoint(s) of evaluation of this end point: within 30 days after surgery	—

Measure

Time frame

Main Objective: To assess the impact of a flash dose of preoperative corticosteroids versus placebo on the onset of major complications (Clavien-Dindo >2) within 30 days after elective curative-intent surgery for digestive cancer.;Secondary Objective: 1. EFFICACY: to assess the effect of a perioperatoive flash of corticosteroids versus placebo on : - Overall survival at 3 years - Disease-free survival at 3 years - Postoperative infections at D30 - Intraabdominal infections at D30 - Hospital stay duration 2. SAFETY : to assess the safety of perioperative flash of corticosteroids.;Primary end point(s): Frequency of patients with major postoperative complications, occurring within 30 days after surgery (D30) and defined as all complications with Clavien-Dindo grade>2.;Timepoint(s) of evaluation of this end point: within 30 days after surgery

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Secondary

Measure	Time frame
Secondary end point(s): 1. Efficacy: - Overall survival at 3 years (defined as the time from surgery to death from any cause) - Disease-free survival at 3 years (defined as the time from surgery to first documented progressive disease or death from any cause, whichever occurs first. - Frequency of patients with postoperative infections occurring within 30 days after surgery and defined according to the CDC definition (Appendix 1). - Frequency of patients with intraabdominal infections (including anastomotic fistula and intraabdominal abscess) within 30 days after surgery and defined according to the CDC definition (Appendix 2) - Number of hospitalization days. In the case of death, patients will be considered as hospitalized until D30 2. Safety: frequency and type of side effects, particularly hyperglycemia and electrolyte disorders assessed by glycemia and an electrolyte panel within the first 24 postoperative hours, and wound healing assessed by clinical inspection at the D30 follow-up visit;Timepoint(s) of evaluation of this end point: 1. Efficacy: - overall survival: 3 years - disease-free survival: 3 years - frequency of patients with postoperative infections: 30 days - frequency of patients with intraabdominal infections: 30 days - number of hospitalization days: 30 days 2. Safety: - frequency and type of side effects: 24 postoperative hours - wound healing : 30 days	—

Measure

Time frame

Secondary end point(s): 1. Efficacy: - Overall survival at 3 years (defined as the time from surgery to death from any cause) - Disease-free survival at 3 years (defined as the time from surgery to first documented progressive disease or death from any cause, whichever occurs first. - Frequency of patients with postoperative infections occurring within 30 days after surgery and defined according to the CDC definition (Appendix 1). - Frequency of patients with intraabdominal infections (including anastomotic fistula and intraabdominal abscess) within 30 days after surgery and defined according to the CDC definition (Appendix 2) - Number of hospitalization days. In the case of death, patients will be considered as hospitalized until D30 2. Safety: frequency and type of side effects, particularly hyperglycemia and electrolyte disorders assessed by glycemia and an electrolyte panel within the first 24 postoperative hours, and wound healing assessed by clinical inspection at the D30 follow-up visit;Timepoint(s) of evaluation of this end point: 1. Efficacy: - overall survival: 3 years - disease-free survival: 3 years - frequency of patients with postoperative infections: 30 days - frequency of patients with intraabdominal infections: 30 days - number of hospitalization days: 30 days 2. Safety: - frequency and type of side effects: 24 postoperative hours - wound healing : 30 days

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Countries

France

Contacts

Public ContactChef de projets recherche

CHU Dijon Bourgogne

Outcome results