UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015196 |
|---|---|
| Receipt number | R000017664 |
| Scientific Title | The evaluation of nutritional recovery after open and laparoscopic gastrectomies for early gastric cancer |
| Date of disclosure of the study information | 2014/09/17 |
| Last modified on | 2017/09/20 17:38:40 |
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Basic information
Public title
The evaluation of nutritional recovery after open and laparoscopic gastrectomies for early gastric cancer
Acronym
CCOG1204
Scientific Title
The evaluation of nutritional recovery after open and laparoscopic gastrectomies for early gastric cancer
Scientific Title:Acronym
CCOG1204
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate that the nutritional recovery after laparoscopic gastrectomies for gastric cancer patients who are diagnosed to be Stage 1A/1B is superior to after open gastrectomies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variation of the total amount of muscles 6 months after open and laparoscopic gastrectomy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Gastric cancer patients who are diagnosed to be Stage 1A/1B according to the Japanease classification for gastric cancer
2. Patients who are going to undergo distal gastrectomy
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
2) Body mass index more than 30
3) Uncontrollable hypertension or uncontrollable diabetes mellitus
4) Continuous systemic steroid therapy
5) Otherwise considered inadequate for inclusion in this trial by the physician
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya University, Graduate School of Medicine
Division name
Gastroenterorogical Surgery
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya city
TEL
052-744-2253
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenobu Matsushita |
Organization
Tosei General Hospital
Division name
Surgery
Zip code
Address
160 Nishioiwake-cho Seto city
TEL
0561-82-5101
Homepage URL
hidenobu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Chubu Clinical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Chubu Clinical Oncology Group
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
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
| 2014 | Year | 09 | Month | 17 | 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
| 2012 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Key inclusion criteria:
1. Gastric cancer patients who are diagnosed to be Stage 1A/1B according to the Japanease classification for gastric cancer
2. Patients who are going to undergo distal gastrectomy
Key exclusion criteria:
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
2) Body mass index more than 30
3) Uncontrollable hypertension or uncontrollable diabetes mellitus
4) Continuous systemic steroid therapy
5) Otherwise considered inadequate for inclusion in this trial by the physician
Management information
Registered date
| 2014 | Year | 09 | Month | 17 | Day |
Last modified on
| 2017 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017664
