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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Dijon | Dijon | 21079 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35999521 | Derived | 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. |
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| 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. |
|
| Blood samples | Biological | electrolyte panel and glycemia performed within the first 24 hours after surgery. |
|
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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