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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000648
Receipt No. R000000782
Scientific Title A phase III study on the anti-SSI effects of preoperative immunonutrient for patients who undergo total gastrectomy for gastric cancer
Date of disclosure of the study information 2007/04/01
Last modified on 2010/03/24

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Basic information
Public title A phase III study on the anti-SSI effects of preoperative immunonutrient for patients who undergo total gastrectomy for gastric cancer
Acronym OGSG 0507
Scientific Title A phase III study on the anti-SSI effects of preoperative immunonutrient for patients who undergo total gastrectomy for gastric cancer
Scientific Title:Acronym OGSG 0507
Region
Japan

Condition
Condition Patients who undergo total gastrectomy for gastric cancer
Classification by specialty
Medicine in general Gastroenterology Infectious disease
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the effects of preoperative immunonutrient(Impact) for the patients who undergo total gastrectomy for gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes primary endpoint
incidence of SSI
secondary endpoints
incidence of infection
postoperative CRP
postoperative complications
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 Group A: Inpact + free food intake
Inpact 1000ml/day during preoperative 5 days and
free food intake
remorize about Inpact intake and administration of
antibiotics
Interventions/Control_2 Group B: Free food intake
without any administration of Inpact
memorize the administration of antibiotics
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. gastric cancer confirmed by endoscopy and histology
2. required the total gastrectomy
3. with a scheduled day for surgical operation
4. patient who can take the immunonutrient for preoperative 5 days
5. without severe weight loss (within -10%)
6. with sufficient function on the liver, kidney and bone marrow
7. age 20<= and 80>=
8. written informed consent
Key exclusion criteria 1. with other severe diseases
2. with some obstruction and/or bleeding on digestive tract
3. with active infectious diseases
4. patient who needs emergent operation
5. patient under some organ failure
6. uncontrolled DM or insulin controlled DM
7. without agreement of doctor
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsujinaka Toshimasa
Organization National Hospital Organization
Osaka Medical Center
Division name Dpt.Surgery
Zip code
Address 2-1-14,Houenzaka,Chuou-ku,Osaka,569-0801
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Furukawa Hiroshi
Organization Sakai City Hospital
Division name Director
Zip code
Address 1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL 0722-21-1700
Homepage URL
Email hfuruk@pop07.oden.ne.jp

Sponsor
Institute Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
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
2007 Year 04 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 10 Month 18 Day
Date of IRB
Anticipated trial start date
2005 Year 11 Month 01 Day
Last follow-up date
2008 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 03 Month 22 Day
Last modified on
2010 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000782

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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