UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040918 |
|---|---|
| Receipt number | R000046307 |
| Scientific Title | Randomized control trial of esophago-gastrostomy versus double-tract in laparoscopic proximal gastrectomy |
| Date of disclosure of the study information | 2020/06/27 |
| Last modified on | 2020/06/27 17:31:27 |
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Basic information
Public title
Randomized control trial of esophago-gastrostomy versus double-tract in laparoscopic proximal gastrectomy
Acronym
Randomized control trial of esophago-gastrostomy versus double-tract in laparoscopic proximal gastrectomy
Scientific Title
Randomized control trial of esophago-gastrostomy versus double-tract in laparoscopic proximal gastrectomy
Scientific Title:Acronym
Randomized control trial of esophago-gastrostomy versus double-tract in laparoscopic proximal gastrectomy
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the best reconstruction method after laparoscopic proximal gastrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of weight loss 1 year after surgery.
Key secondary outcomes
Operative time, Complication, The percentage of conversion to laparotomy, Nutritional assessment, Reflux esophagitis, Recurrence-free survival, Overall Survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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 arm of esophagogastrostomy.
Interventions/Control_2
The arm of double tract 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically diagnosed unresectable advanced or recurrent gastric or esophagogastric junction adenocarcinoma.
2) Scheduled for Proximal gastrectomy.
3) cStage I.
4) Age over 20 years old.
5) PS:0-2(ECOG).
6) BMI under 30.
8) No history of upper abdominal surgery
9) No history of chemotherapy, radiation, hormone therapy, molecular target drugs.
6) Written informed consent.
Key exclusion criteria
1) With double cancer.
2) Have an infectious disease that requires systemic treatment.
3) Pregnant or lactating.
4) Psychosis.
5) Administration of steroids.
6) History of myocardial infarction.
7) With uncontrolled hypertension.
8) With uncontrolled diabetes.
9) With respiratory disease requiring continuous oxygen administration.
10) Renal failure requiring hemodialysis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Yamasaki |
Organization
Graduated School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2-E2, Yamadaoka, Suita City, Osaka
TEL
06-6879-3251
myamasaki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Yamasaki |
Organization
Graduated School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2-E2, Yamadaoka, Suita City, Osaka
TEL
06-6879-3251
Homepage URL
myamasaki@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Oasaka University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka International Cancer Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University
Address
2-2-E2, Yamadaoka, Suita City, Osaka
Tel
06-6879-3251
myamasaki@gesurg.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
19206-2
Org. issuing International ID_1
Osaka International Cancer Institute
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 27 | 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
| 2020 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 27 | Day |
Last modified on
| 2020 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046307
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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