UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003299 |
|---|---|
| Receipt number | R000002282 |
| Scientific Title | Clinical trial of ghrelin administration after esophagectomy with gastric tube reconstruction in early postoperative period. |
| Date of disclosure of the study information | 2010/03/10 |
| Last modified on | 2011/02/10 17:00:10 |
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Basic information
Public title
Clinical trial of ghrelin administration after esophagectomy with gastric tube reconstruction in early postoperative period.
Acronym
Clinical trial of ghrelin after esophagectomy in early postoperative period.
Scientific Title
Clinical trial of ghrelin administration after esophagectomy with gastric tube reconstruction in early postoperative period.
Scientific Title:Acronym
Clinical trial of ghrelin after esophagectomy in early postoperative period.
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of ghrelin administratio after esophagectomy with gastric tube reconstruction in early postoperative period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Duration of SIRS
Complications
Key secondary outcomes
Nitrogen balance
Body weight
Body composition
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
All enrolled patients will be administered an intravenous infusion of synthetic human ghrelin repeated bid for 10 days from the first operative day.
Interventions/Control_2
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
with severe co morbid conditions, infectious diseases and a past history of drug allergy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Graduate School of Mdicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL
06-679-3251
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
Zip code
Address
2-2-E, Yamadaoka, Suita, Osaka, Japan
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 | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 08 | Day |
Last modified on
| 2011 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002282
