Unique ID issued by UMIN | UMIN000007077 |
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Receipt number | R000008334 |
Scientific Title | Randomized phase II study of clinical effects of ghrelin the perioperative period of esophagectomy with gastric tube reconstruction. |
Date of disclosure of the study information | 2012/01/16 |
Last modified on | 2014/05/25 23:35:59 |
Randomized phase II study of clinical effects of ghrelin the perioperative period of esophagectomy with gastric tube reconstruction.
Randomized phase II study of clinical effects of ghrelin the perioperative period of esophagectomy with gastric tube reconstruction.
Randomized phase II study of clinical effects of ghrelin the perioperative period of esophagectomy with gastric tube reconstruction.
Randomized phase II study of clinical effects of ghrelin the perioperative period of esophagectomy with gastric tube reconstruction.
Japan |
Esophageal cancer
Surgery in general | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy of ghrelin administration in perioperative period of esophagectomy with gastric tube reconstruction in early postoperative period.
Efficacy
Exploratory
Pragmatic
Phase II
Duration of SIRS Complications
Nitrogen balance,Body weight,Body composition, Blood test
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
NO
NO
NO
Central registration
2
Treatment
Medicine |
Prospective randomized, placebo-controlled clinical trial assigned a total of 40 patients with thoracic esophageal cancer undergoing radical surgery, into either ghrelin (n=20) or placebo group (n=20). In ghrelin group, synthetic human ghrelin (0.5 micro g/kg/h) was administered intravenously for 5 days from the day of surgery
In placebo group, saline was administered intravenously for 5 days from the day of surgery.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) with thoracic esophageal cancer, underwent radical esophagectomy with gastric tube reconstruction
2) age; 20-75 years
3) adequate function of major organs
4) no other active malignancy
5) provision of written informed consent.
with severe co morbid conditions, infectious diseases and a past history of drug allergy.
40
1st name | |
Middle name | |
Last name | Yuichiro Doki |
Graduate School of Medicine, Osaka University
Department of Gastroenterological Surgery
2-2-E2, Yamadaoka, Suita, Osaka, Japan
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Akihiro Takata |
Graduate School of Medicine, Osaka University
Department of Gastroenterological Surgery
2-2-E2, Yamadaoka, Suita, Osaka, Japan
06-6879-3251
atakata@gesurg.med.osaka-u.ac.jp
Department of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University
Ministry of Health, Labor and Welfare, and Ministry of Education, Culture, Sports, Science and Technology
Japan
NO
大阪大学医学部附属病院(大阪府)
2012 | Year | 01 | Month | 16 | Day |
Unpublished
Completed
2012 | Year | 01 | Month | 16 | Day |
2012 | Year | 02 | Month | 01 | Day |
2013 | Year | 10 | Month | 25 | Day |
2013 | Year | 12 | Month | 31 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 03 | Month | 31 | Day |
2012 | Year | 01 | Month | 16 | Day |
2014 | Year | 05 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008334
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