Preoperative High Dose Steroids for Liver Resection- Effect on Complications in the Immediate Postoperative Period

• Status: Completed
• Trial end date: 2020-09-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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