Unique ID issued by UMIN | UMIN000001944 |
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Receipt number | R000002364 |
Scientific Title | Perioperative steroids administration in hepatectomy: A prospective randomized study |
Date of disclosure of the study information | 2009/05/07 |
Last modified on | 2010/11/06 18:37:19 |
Perioperative steroids administration in hepatectomy: A prospective randomized study
Perioperative steroids administration in hepatectomy
Perioperative steroids administration in hepatectomy: A prospective randomized study
Perioperative steroids administration in hepatectomy
Japan |
The patients who were planned to hepatic resection in the Department of Digestive Surgery at Nihon University Itabashi Hospital, Tokyo, Japan.
Surgery in general | Hepato-biliary-pancreatic surgery |
Malignancy
NO
There is no consensus on the beneficial effects of perioperative steroid administrations in patients undergoing hepatectomy. The aim of this prospective randomized controlled study was to investigate the clinical benefits of perioperative steroid administration.
Efficacy
Confirmatory
Pragmatic
Phase III
The primary endpoint was serum level of total bilirubin (T.bil) on POD2.
The other serum levels related to liver function, inflammatory cytokine levels, and postoperative complications were also compared between the two groups.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
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
15 | years-old | <= |
84 | years-old | >= |
Male and Female
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)
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)
200
1st name | |
Middle name | |
Last name | Shintaro Yamazaki |
Nihon University School of Medicine
Department of Digestive Surgery
30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo
03-3972-8111
1st name | |
Middle name | |
Last name | Shintaro Yamazaki |
Nihon University School of Medicine
Department of Digestive Surgery
yamazaki-nmed@umin.ac.jp
Nihon University School of Medicine, Itabashi Hospital
Grants-in-Aid for Scientific Research from the Ministry of Education Science and Culture of Japan.
NO
2009 | Year | 05 | Month | 07 | Day |
Published
Completed
2006 | Year | 07 | Month | 01 | Day |
2006 | Year | 07 | Month | 01 | Day |
2009 | Year | 07 | Month | 01 | Day |
2009 | Year | 05 | Month | 06 | Day |
2010 | Year | 11 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002364
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