Perioperative steroids administration in hepatectomy: A prospective randomized study

UMIN ID: UMIN000001944

Registered date:07/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: The patients who were planned to hepatic resection in the Department of Digestive Surgery at Nihon University Itabashi Hospital, Tokyo, Japan.
• Date of first enrollment: 2006/07/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The patients were assigned randomly to a control group or a steroid group in which patients received 500mg of hydrocortizon just before hepatic pedicle clamping, 300mg on postoperative day (POD) 1, 200mg on day2 and 100mg on day3.
administration only saline solution

Outcome(s)

• Primary Outcome: The primary endpoint was serum level of total bilirubin (T.bil) on POD2.
• Secondary Outcome: The other serum levels related to liver function, inflammatory cytokine levels, and postoperative complications were also compared between the two groups.

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 84years-old
• Gender: Male and Female
• Exclude criteria: Eligibility criteria included from 15 to 84 years patients who were planned to hepatic resection and had adequate functional reserve of the heart, lungs, and kidneys. Patients were excluded who if they had already treated with taken steroids, had unstable condition of gastric ulcer or past history of acute myocardial infarction. Randomization stratified by Child-Pugh class (A or B)

Related Information

• Primary Sponsor: Nihon University School of Medicine, Itabashi Hospital
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research from the Ministry of Education Science and Culture of Japan.