UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003298 |
|---|---|
| Receipt number | 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 17:39:16 |
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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
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
kayamamoto@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002483
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
