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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003786
Receipt No. R000004580
Scientific Title A randomized comparison of chemically assisted ESD with submucosal injection of mesna and standard ESD.
Date of disclosure of the study information 2010/06/21
Last modified on 2012/11/09

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Basic information
Public title A randomized comparison of chemically assisted ESD with submucosal injection of mesna and standard ESD.
Acronym A RCT of CA-ESD using mesna and standard ESD.
Scientific Title A randomized comparison of chemically assisted ESD with submucosal injection of mesna and standard ESD.
Scientific Title:Acronym A RCT of CA-ESD using mesna and standard ESD.
Region
Japan

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

Objectives
Narrative objectives1 ESD has enabled us to radically excise superficial early stage gastric cancer. However, ESD carries higher risk of complications due to the technical difficulty of endoscopic dissection of the submucosal layer. Preceding animal and clinical pilot studies demonstrated that a mucolytic agent, so called mesna could chemically soften the submucosal tissue plane and facilitated the submucosal dissection process in ESD. In order to clarify the advantage of this chemically assisted ESD technique over standard procedures, we will compare outcomes of chemically assisted ESD and standard ESD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Procedural time
Key secondary outcomes Procedural success rate
En bloc resection rate
Complication and side effect rates
The healing process of post therapeutic ulceration
Histological analysis of chemical effect on sampled specimens

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Using mesna as a submucosal injection solution
Interventions/Control_2 Using saline as a submucosal injection solution
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 Gastric neoplasias with indications of ESD
Key exclusion criteria History of hypersensitivity to mesna and women who were pregnant, lactating, or hoping to become pregnant during this study period
Target sample size 100

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 105-8461, Japan
TEL
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
Institute
Department

Funding Source
Organization Research fund of The Jikei University School of Medicine, Department of Endoscopy.
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
2010 Year 06 Month 21 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 Enrolling by invitation
Date of protocol fixation
2010 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 06 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 06 Month 19 Day
Last modified on
2012 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004580

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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