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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001868
Receipt No. R000002248
Scientific Title Partial gastrectomy with combined endoscopic and laparoscopic approach for early gastric cancer
Date of disclosure of the study information 2009/04/10
Last modified on 2015/04/02

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Basic information
Public title Partial gastrectomy with combined endoscopic and laparoscopic approach for early gastric cancer
Acronym Partial gastrectomy with combined endoscopic and laparoscopic approach
Scientific Title Partial gastrectomy with combined endoscopic and laparoscopic approach for early gastric cancer
Scientific Title:Acronym Partial gastrectomy with combined endoscopic and laparoscopic approach
Region
Japan

Condition
Condition early gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will evaluate the curability and less invasiveness of full thickness resection with combined endoscopic and laparoscopic approach for early gastric cancer which is not indicated for endoscopic submucosal dissection (ESD).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Relapse-free survival
Key secondary outcomes Success rate, intra and post-operative morbidity, and overall survival rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Full thickness resection and limited lymphadenectomy with combined endoscopic and laparoscopic approach for early gastric cancer.
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Early gastric cancer patient
Informed consent
Key exclusion criteria lymph node metastasis
distant metastasis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiro Inoue, MD, PhD
Organization Showa University Koto Toyosu Hospital
Division name Digestive Disease Center
Zip code
Address 5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL 03-6204-6000
Email haruinoue777@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruhiro Inoue, MD, PhD
Organization Showa University Koto Toyosu Hospital
Division name Digestive Disease Center
Zip code
Address 5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL 03-6204-6000
Homepage URL
Email haruinoue777@yahoo.co.jp

Sponsor
Institute Digestive Disease Center, Showa University Koto Toyosu Hospital
Institute
Department

Funding Source
Organization Digestive Disease Center, Showa University Koto Toyosu Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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
2009 Year 04 Month 10 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 Open public recruiting
Date of protocol fixation
2008 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2017 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 10 Day
Last modified on
2015 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002248

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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