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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002010
Receipt No. R000002448
Scientific Title Chemically assisted endoscopic submucosal dissection by using mesna.
Date of disclosure of the study information 2009/05/26
Last modified on 2009/05/26

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Basic information
Public title Chemically assisted endoscopic submucosal dissection by using mesna.
Acronym Chemically assisted ESD by using mesna.
Scientific Title Chemically assisted endoscopic submucosal dissection by using mesna.
Scientific Title:Acronym Chemically assisted ESD by using mesna.
Region
Japan

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

Objectives
Narrative objectives1 To investigate efficacy and safety of mesna as a submucosal injectable solution for the endoscopic submucosal dissection technique.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Technical success
Key secondary outcomes En bloc resection rate, Short and long term complication.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 ESD after submucosal injection of mesna.
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 stage gastric cancer cases suitable for ESD resection.
Key exclusion criteria Patients with allergic history to
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuki Sumiyama
Organization The Jikei University School of Medicine
Division name Department of endoscopy
Zip code
Address 3-25-8 Nishi Shinbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Jikei University School of Medicine
Division name Department of endoscopy
Zip code
Address
TEL
Homepage URL
Email kaz_sum@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine, Department of Endsocopy
Institute
Department

Funding Source
Organization The Jikei University School of Medicine, Department of Endsocopy
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 05 Month 26 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
Date of protocol fixation
2009 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2011 Year 05 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 05 Month 26 Day
Last modified on
2009 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002448

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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