Effects of high dose steroids on complications after liver resection -a randomized, double-blind, controlled trial

Phase 1

• Conditions: Complications after liver resections - due to liver disease (mainly primary liver cancer and metastases); MedDRA version: 20.0Level: LLTClassification code 10036278Term: Postoperative complications NOSSystem Organ Class: 100000020453; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-002652-81-DK
• Lead Sponsor: Eske Kvanner Aasvang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-30
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

Age at or above 18 years
Open liver resection, including combined ablation and/or cholecystectomy in the study period
Signed informed consent
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 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Associated liver partition and portal vein ligation (ALPPS) procedure
•Simultaneous ventral herniotomy with implantation of mesh
•Simultaneous operation for primary tumor in other organs
•Insuline dependent diabetes
• Ongoing (< 10 days) treatment with systemic corticosteroids/immunosuppressive therapy (except inhalations)
•Pregnancy/Breastfeeding
•Allergies towards study medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified