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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003364
Receipt No. 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

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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
Email 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
Email ydoki@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka university, Graduate School of Medicine, Gastroenterological Surgery
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004089

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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