UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012062 |
|---|---|
| Receipt number | R000014100 |
| Scientific Title | A prospective randomized controlled trial comparing antecolic route and retroclic route with Roux-Y reconstruction after distal gastrectomy. |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2013/10/17 17:56:48 |
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Basic information
Public title
A prospective randomized controlled trial comparing antecolic route and retroclic route with Roux-Y reconstruction after distal gastrectomy.
Acronym
A prospective randomized controlled trial comparing antecolic route and retroclic route with Roux-Y reconstruction after distal gastrectomy.
Scientific Title
A prospective randomized controlled trial comparing antecolic route and retroclic route with Roux-Y reconstruction after distal gastrectomy.
Scientific Title:Acronym
A prospective randomized controlled trial comparing antecolic route and retroclic route with Roux-Y reconstruction after distal gastrectomy.
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clear which reconstructive route is better, antecolic or retrocolic route
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Change of EGJ morphology(incidence of hital hernia)
Key secondary outcomes
incidence of GERD(by endoscopic findings, reflux symptoms, and 24h pH and bilirubin monitoring.)
postoperative complication
postoperative gastrointesitical function
postoperative QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
antecolic route
Interventions/Control_2
retrocolic route
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who can undergo distal gastricetomy with Roux-Y reconstruction.
Key exclusion criteria
Patients with unresctal leasion such as peritonial dissemination and multiple metastases, and para-aortic lymph node metastases.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich, Japan
TEL
052-744-2222
nagino@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mashide Fukaya |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich, Japan
TEL
052-744-2222
Homepage URL
mafukaya@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 17 | Day |
Last modified on
| 2013 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014100
