UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013044 |
|---|---|
| Receipt number | R000015220 |
| Scientific Title | Functional outcomes by reconstruction technique following laparoscopic proximal gastrectomy for gastric cancer: double tract versus jejunal interposition |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2014/02/01 18:50:18 |
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Basic information
Public title
Functional outcomes by reconstruction technique following laparoscopic proximal gastrectomy for gastric cancer: double tract versus jejunal interposition
Acronym
Functional outcomes by reconstruction technique following laparoscopic proximal gastrectomy: double tract vs. jejunal interposition
Scientific Title
Functional outcomes by reconstruction technique following laparoscopic proximal gastrectomy for gastric cancer: double tract versus jejunal interposition
Scientific Title:Acronym
Functional outcomes by reconstruction technique following laparoscopic proximal gastrectomy: double tract vs. jejunal interposition
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of the quality of life and functional evaluations of patients having proximal gastrectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Postopereative/preopereative body weight ratio
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
the double tract construction
Interventions/Control_2
the jejunal interposition reconstruction
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
early gastric cancer located in the upper third of the stomach
Key exclusion criteria
1)Women who are pregnant/possibly pregnant or breastfeeding. 2)Patients who are continuing to use a systemic steroid preparation (oral or intravenous).
3)Patients with the complication of poorly controlled diabetes mellitus (HbA1C>8.0). 4)Patients with the complication of psychiatric disorders or psychiatric symptoms, and who are judged to have difficulty participating in the study.5)Other patients who are considered not suitable for participation in this study by the physician in charge.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Nomura |
Organization
Osaka Medical College
Division name
General & Gastroenterological Surgery
Zip code
Address
Daigaku-machi 2-7, Takatsuki City, Osaka
TEL
072-683-1221
sur035@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sang-Woong Lee |
Organization
Osaka Medical College
Division name
General & Gastroenterological Surgery
Zip code
Address
Daigaku-machi 2-7, Takatsuki City, Osaka
TEL
072-683-1221
Homepage URL
sur079@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medial College
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 02 | Month | 01 | 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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 01 | Day |
Last modified on
| 2014 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015220
