UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003364 |
|---|---|
| Receipt number | R000004089 |
| Scientific Title | Effects of preservation of celiac branch of the vagus nerve after distal gastrectomy for gastric cancer. A prospective randomized controlled phase II study. |
| Date of disclosure of the study information | 2010/03/23 |
| Last modified on | 2015/03/25 16:38:12 |
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Basic information
Public title
Effects of preservation of celiac branch of the vagus nerve after distal gastrectomy for gastric cancer. A prospective randomized controlled phase II study.
Acronym
Effects of preservation of celiac branch of the vagus nerve after distal gastrectomy for gastric cancer. A prospective randomized controlled phase II study.
Scientific Title
Effects of preservation of celiac branch of the vagus nerve after distal gastrectomy for gastric cancer. A prospective randomized controlled phase II study.
Scientific Title:Acronym
Effects of preservation of celiac branch of the vagus nerve after distal gastrectomy for gastric cancer. A prospective randomized controlled phase II study.
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effect of preservation of celiac branch of vagus nerve after distal gastrectomy for gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is the rate of gallstone two years after operation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
distal gastrectomy with preservation of celiac branch of vagus nerve
Interventions/Control_2
distal gastrectomy without preservation of celiac branch of vagus nerve
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.gastric cancer with T1 invasion (lesion confined to the mucosa or the submucosa) and the tumors found to have submucosal invasion after EMR or ESD.
2.require distal gastrectomy
3.resectable lymph-nodes with preservation of hepatic and celiac branch of vagus nerve
4.Age; 20-90 years
5.Performance status 0-1
6.resectable D1 lymph-nodes with curability A or B
7.no abnormity in gallbladder or bile passage
8.informed consent is obtained
Key exclusion criteria
1.post cholecystectomy or with abnormity in bile passage
2.peritoneal dissemination, hepatic metastasis, distant metastasis, invade other organ
3.history of any other malignancy which is including synchronal double cancer, but they are not including the carcinoma in situ or intramucosal cancer diagnosed as cure by local procedure
4.double cancer of disease free for less than 5 years
5.severe respiratory disease
6.cardiac infarction
7.hepatic cirrhosis or active hepatitis
8.chronic renal failure accompanied by hemodialysis
9.diabetes (HbA1c>9.0)
10.patient who is judged as an inappropriate case by the doctor in charge
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka University, Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, Yamadaoka, Suita city, Osaka, Japan. 565-0871
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka University, Graduate School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2, Yamadaoka, Suita city, Osaka, Japan.
TEL
06-6879-3251
Homepage URL
ydoki@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university, Graduate School of Medicine, Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 03 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | 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
| 2010 | Year | 03 | Month | 23 | Day |
Last modified on
| 2015 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004089
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
