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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001925
Receipt No. R000002341
Scientific Title Effects of ghrelin administration after total gastrectomy in patients with gastric cancer: A prospective randomized placebo-controlled phase II study
Date of disclosure of the study information 2009/05/01
Last modified on 2009/04/30

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Basic information
Public title Effects of ghrelin administration after total gastrectomy in patients with gastric cancer: A prospective randomized placebo-controlled phase II study
Acronym Effects of ghrelin administration after total gastrectomy in patients with gastric cancer: A prospective randomized placebo-controlled phase II study
Scientific Title Effects of ghrelin administration after total gastrectomy in patients with gastric cancer: A prospective randomized placebo-controlled phase II study
Scientific Title:Acronym Effects of ghrelin administration after total gastrectomy in patients with gastric cancer: A prospective randomized placebo-controlled phase II study
Region
Japan

Condition
Condition Gastric cancer patients who underwent total gastrectomy.
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate whether exogenous ghrelin administration prevents postoperative body weight loss by improving appetite and oral food intake in patients with gastric cancer after undergoing total gastrectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Food intake calories (during 10-days ghrelin administration)
Key secondary outcomes appetite VAS, postoperative body weight, postoperative BMI (during 10-days ghrelin administration)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention A; ghrelin group (+)
ghrelin administration
postoperative 10-days
twice a day
before breakfast and before dinner
Interventions/Control_2 Intervention B; placebo group (-)
saline administration
postoperative 10-days
twice a day
before breakfast and before dinner
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 The inclusion criteria were as follows: 1) adenocarcinoma of the stomach confirmed by histopathological examination, 2) preoperative clinical staging with less than stage II (UICC TNM stage classification), 3) curative surgical treatment (R0), i.e., TG with D1 or D2 lymph node dissection, and 4) Age >20 and <80 years.
Key exclusion criteria The exclusion criteria were the presence of any of the following; 1) cardiopulmonary, liver or renal dysfunction, 2) active dual malignancy, 3) pregnancy, 4) past history of gastrointestinal surgery, 5) postoperative complications after TG that could affect oral food intake, such as anastomotic leakage, pancreatitis and ileus.
Target sample size 20

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

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Takiguchi
Organization Osaka University School of Medicine
Division name Gastroenterological Surgery
Zip code
Address
TEL 06-6879-3251
Homepage URL
Email

Sponsor
Institute Osaka University School of Medicine Gastroenterological Surgery
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 05 Month 01 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
2005 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
2008 Year 06 Month 01 Day
Date trial data considered complete
2008 Year 06 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 04 Month 30 Day
Last modified on
2009 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002341

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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