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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004942
Receipt No. R000005705
Scientific Title Randomized controlled study of Flush knife versus Mucosectome in endoscopic submucosal dissection for superficial esophageal cancer
Date of disclosure of the study information 2011/01/25
Last modified on 2012/07/26

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Basic information
Public title Randomized controlled study of Flush knife versus Mucosectome in endoscopic submucosal dissection for superficial esophageal cancer
Acronym Randomized study comparing ESD device.
Scientific Title Randomized controlled study of Flush knife versus Mucosectome in endoscopic submucosal dissection for superficial esophageal cancer
Scientific Title:Acronym Randomized study comparing ESD device.
Region
Japan

Condition
Condition superficial esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Mucosectome compared with Flush knife in esophageal ESD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Procedure time of submucosal dissection
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 ESD using Flush knife
Interventions/Control_2 ESD using Mucosectome
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 Superficial esophageal squamous cell carcinoma 15mm - 50mm in diameter, circumferential spread 1/2 or less.
Key exclusion criteria 1)Patients with past history of operation, chemotherapy or radiotherapy for esophageal cancer.
2)Local recurrence after endoscopic resection.
3)Patients with iodine allergy.
4)Lesions those are extending into pharyngoesophageal junction or esophago-gastric junction.
5)Patients with esophageal lesion in the area of reflux esophagitis.
6)Patients with hematological abnormality.
7)Patients with severe organ failure
8)Patients who have been judged as inappropriate for this study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryu Ishihara
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastrointestinal Oncology
Zip code
Address 3-3, Nakamichi 1-chome, Higashinari-ku, Osaka, 537-8511, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiromitsu Kanzaki
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastrointestinal Oncology
Zip code
Address
TEL
Homepage URL
Email kanzai-hi@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
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 大阪府立成人病センター(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 25 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 Completed
Date of protocol fixation
2011 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2012 Year 07 Month 01 Day
Date of closure to data entry
2012 Year 07 Month 01 Day
Date trial data considered complete
2012 Year 07 Month 01 Day
Date analysis concluded
2012 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 25 Day
Last modified on
2012 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005705

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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