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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017120
Receipt No. R000019857
Scientific Title Feasibility study of endoscopic submucosal dissection with a 1 cm safety margin for adenocarcinomas of the esophagogastric junction
Date of disclosure of the study information 2015/04/13
Last modified on 2017/10/16

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Basic information
Public title Feasibility study of endoscopic submucosal dissection with a 1 cm safety margin for adenocarcinomas of the esophagogastric junction
Acronym ESD for adenocarcinomas of the esophagogastric junction
Scientific Title Feasibility study of endoscopic submucosal dissection with a 1 cm safety margin for adenocarcinomas of the esophagogastric junction
Scientific Title:Acronym ESD for adenocarcinomas of the esophagogastric junction
Region
Japan

Condition
Condition adenocarcinomas of the esophagogastric junction
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clarify the efficacy of 1 cm safety margin for ESD of adenocarcinomas of the esophagogastric junction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete resection rates (RO resection rates)
Key secondary outcomes Incidence of subsquamous carcinoma extension
Length of subsquamous carcinoma extension
Accuracy of endoscopic diagnosing with subsquamous carcinoma extension
Curative resection rates, Adverse event tates

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
Maneuver
Interventions/Control_1 ESD with 1 cm safety margin
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with tumor located on esophagogastric junction and diagnosed Siewert classificaion II by endoscopy
2. Patients with tumor pathologically diagnosed adenocarcinoma or suspected adenocarcinoma
3. Patients with tumor diagnosed cT1-M by endoscopy
4. Patients without lymph node or distal metastasis by CT
5. Patients over 19 age
6. Patients with provision of written informed consent regarding study partcipation
Key exclusion criteria 1. Patients without agreement
2. Possibility of pregnancy and lactation
3. Severe mental illness
4. Continuous systemic steroid intake
5. Active bacterial or fungal infection
6. Cardiac infarction or unstable angina pectoris since 3 months before
7, 8. Uncontrorable hypertension or diabetes mellitus
9. Pulmonary disease required oxigen
10. ther reasons which made the subject ineligible to participate in this study, at the discretion of the chief investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuaki Nagami
Organization Osaka City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL 06-6645-3811
Email yasuaki-75@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuaki Nagami
Organization Osaka City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL 06-6645-3811
Homepage URL
Email yasuaki-75@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine
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 大阪市立大学医学部付属病院 消化器内科

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 13 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
2015 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 14 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 13 Day
Last modified on
2017 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019857

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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