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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007077
Receipt No. R000008334
Scientific Title Randomized phase II study of clinical effects of ghrelin the perioperative period of esophagectomy with gastric tube reconstruction.
Date of disclosure of the study information 2012/01/16
Last modified on 2014/05/25

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Basic information
Public title Randomized phase II study of clinical effects of ghrelin the perioperative period of esophagectomy with gastric tube reconstruction.
Acronym Randomized phase II study of clinical effects of ghrelin the perioperative period of esophagectomy with gastric tube reconstruction.
Scientific Title Randomized phase II study of clinical effects of ghrelin the perioperative period of esophagectomy with gastric tube reconstruction.
Scientific Title:Acronym Randomized phase II study of clinical effects of ghrelin the perioperative period of esophagectomy with gastric tube reconstruction.
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of ghrelin administration in perioperative period of 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, Blood test

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 40 patients with thoracic esophageal cancer undergoing radical surgery, into either ghrelin (n=20) or placebo group (n=20). In ghrelin group, synthetic human ghrelin (0.5 micro g/kg/h) was administered intravenously for 5 days from the day of surgery
Interventions/Control_2 In placebo group, saline was administered intravenously for 5 days from the day of surgery.
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 40

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
Zip code
Address 2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Email ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Takata
Organization Graduate School of Medicine, Osaka University
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Homepage URL
Email atakata@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 Ministry of Health, Labor and Welfare, and Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 16 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
2012 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2013 Year 10 Month 25 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 16 Day
Last modified on
2014 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008334

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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