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

UMIN ID: UMIN000003298

Registered date:09/03/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: patients with thoracic esophageal cancer, undergoing radical surgery
• Date of first enrollment: 2008/02/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

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 Outcome: Oral intake calories
• Secondary Outcome: appetite (VAS) postoperatibe weight loss body composition

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Patients ineligible for inclusion were those with severe co morbid conditions, other active malignancy, infectious diseases and a past history of drug allergy.

Related Information

• Primary Sponsor: Department of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University
• Source(s) of Monetary Support: none