Preoperative High Dose Steroids for Liver Resection- Effect on Complications in the Immediate Postoperative Period
Condition: Complication, Postoperative
MeSH terms: Postoperative Complications
Intervention: Methylprednisolone; Dexamethasone
Intervention description: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery; Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery
Intervention MeSH terms: Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: steroids; glucocorticoids; liver surgery; hepatectomy

Summary:

      Background:

      Several randomized clinical trials have shown beneficial effects of pre-operative
      glucocorticoids on post-operative complications.

      Studies on the effects of glucocorticoids on the postoperative recovery after liver-resection
      show significantly lower markers of infection and liver damage, and some studies have shown a
      shorter hospital stay.

      Studies on the effects in the immediate postoperative phase are lacking.

      Methods: Randomized, double-blind, controlled trial evaluating incidence of postoperative
      complications in the immediate postoperative phase (and during admission) after open liver
      surgery. Participants are randomized to either active treatment (methylprednisolone 10 mg/kg)
      or control (8 mg dexamethasone), administered just prior to surgery.

      All patients undergoing open liver resection at our institution are eligible. Included
      patients are stratified according to extent of surgery into minor (<3 segments) or major (≥3
      segments) group.

      Patients in major group participate in Substudy I (markers of endothelial damage).

      Patients operated between January and July 2018 participate in Substudy II (delirium).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age minimum 18

          -  Planned open liver resection (with or without combined ablation and/or

          -  cholecystectomy)

          -  Able to participate (self report pain/nausea)

          -  Understands danish/english, or has an interpreter during admission

          -  Signed consent form

        Exclusion Criteria:

          -  ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy)
             procedure

          -  Combined ventral herniotomy with implantation of mesh

          -  Combined with operation on tumor in other organs

          -  Insulin dependent diabetes

          -  Current (<10 days) treatment with systemic glucocorticoids and/or immunosuppressive
             treatment (not including inhalations)

          -  Epidural anesthesia not feasible

          -  Pregnancy/breastfeeding

          -  Allergy toward study medication

          -  Inoperability