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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001819
Receipt No. R000001979
Scientific Title Prospective study of endoscopic submucosal dissection for early gastric cancer
Date of disclosure of the study information 2009/03/30
Last modified on 2013/04/20

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Basic information
Public title Prospective study of endoscopic submucosal dissection for early gastric cancer
Acronym ESD for early gastric cancer
Scientific Title Prospective study of endoscopic submucosal dissection for early gastric cancer
Scientific Title:Acronym ESD for early gastric cancer
Region
Japan

Condition
Condition Early gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim is this study is to evaluate the efficacy and safety of endoscopic submucosal dissection for early gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Rate of complete resection
Key secondary outcomes Rate of local reccurrence rate, safety, rate of stomach preservation

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 Endoscopic submucosal dissection
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed differentiated adenocarcinoma of the stomach
2) Age of 20-80 years
3) ECOG performance status of 0 to 2
4) Early gastric cancer with single and non recurrence tumor
5) Intramucosal cancer within 20mm in diameter
6) Without ulceration or scar
7) One-piece resection is possible with ESD
8) Adequate organ function
9) Written informed consent
Key exclusion criteria 1) History of gastrectomy
2) Active other malignancies
3) Uncontrollable diabetes mellitus
4) Uncontrollable hypertension
5) History of severe heart disease
6) Anticoagulant or antiplatelet medications
7) Active infection
8) Psychosis
9) Not appropriate for the study at the physician's assessment
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayumu Hosokawa
Organization University of Toyama
Division name Department of Gastroenterology and Hematology, Faculty of Medicine
Zip code
Address 2630 Sugitani, Toyama, 930-0194, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Toyama
Division name Department of Gastroenterology and Hematology, Faculty of Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Hokkaido ESD Group
Institute
Department

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
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 03 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2005 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2005 Year 09 Month 01 Day
Last follow-up date
2010 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 03 Month 30 Day
Last modified on
2013 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001979

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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