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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003298
Receipt No. R000002483
Scientific Title Randomized phase II study of clinical impact of ghrelin after esophagectomy with gastric tube reconstruction
Date of disclosure of the study information 2010/03/09
Last modified on 2010/10/08

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Basic information
Public title Randomized phase II study of clinical impact of ghrelin after esophagectomy with gastric tube reconstruction
Acronym Ghrelin for esophageal cancer patients
Scientific Title Randomized phase II study of clinical impact of ghrelin after esophagectomy with gastric tube reconstruction
Scientific Title:Acronym Ghrelin for esophageal cancer patients
Region
Japan

Condition
Condition patients with thoracic esophageal cancer, undergoing radical surgery
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate whether exogenous ghrelin administration diminishes the post-operative decline of oral food intake and weight after esophagectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Oral intake calories
Key secondary outcomes appetite (VAS)
postoperatibe weight loss
body composition

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 In placebo group, saline was administered intravenously repeated bid for 10 days from the next day of start of food intake.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) with thoracic esophageal cancer, undergoing radical esophagectomy with gastric tube reconstruction,
2) age; 20-80 years,
3) enable to oral intake
4) provision of written informed consent.
Key exclusion criteria Patients ineligible for inclusion were those with severe co morbid conditions,
other active malignancy, infectious diseases and a past history of drug allergy.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Doki
Organization Graduate School of Medicine, Osaka University
Division name Department of Gastroenterological Surgery, Department of Surgery
Zip code
Address 2-2, E2, Yamadaoka, Suita, Osaka
TEL 06-6879-3251
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyoshi Yamamoto
Organization Graduate School of Medicine, Osaka University
Division name Department of Gastroenterological Surgery, Department of Surgery
Zip code
Address 2-2, E2, Yamadaoka, Suita, Osaka
TEL 06-6879-3251
Homepage URL
Email kayamamoto@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2009 Year 05 Month 01 Day
Date of closure to data entry
2009 Year 05 Month 01 Day
Date trial data considered complete
2009 Year 05 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 08 Day
Last modified on
2010 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002483

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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