NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000003298

Registered date:09/03/2010

Randomized phase II study of clinical impact of ghrelin after esophagectomy with gastric tube reconstruction

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedpatients with thoracic esophageal cancer, undergoing radical surgery
Date of first enrollment2008/02/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Prospective randomized, placebo-controlled clinical trial assigned a total of 20 patients with thoracic esophageal cancer undergoing radical surgery, into either ghrelin (n=10) or placebo group (n=10). In ghrelin group, Synthetic human ghrelin (3 micro g/kg) was administered intravenously repeated bid for 10 days from the next day of start of food intake. In placebo group, saline was administered intravenously repeated bid for 10 days from the next day of start of food intake.

Outcome(s)

Primary OutcomeOral intake calories
Secondary Outcomeappetite (VAS) postoperatibe weight loss body composition

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteriaPatients ineligible for inclusion were those with severe co morbid conditions, other active malignancy, infectious diseases and a past history of drug allergy.

Related Information

Contact

public contact
Name Kazuyoshi Yamamoto
Address 2-2, E2, Yamadaoka, Suita, Osaka Japan
Telephone 06-6879-3251
E-mail kayamamoto@gesurg.med.osaka-u.ac.jp
Affiliation Graduate School of Medicine, Osaka University Department of Gastroenterological Surgery, Department of Surgery
scientific contact
Name Yuichiro Doki
Address 2-2, E2, Yamadaoka, Suita, Osaka Japan
Telephone 06-6879-3251
E-mail
Affiliation Graduate School of Medicine, Osaka University Department of Gastroenterological Surgery, Department of Surgery