UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of endoscopic submucosal dissection with a 1 cm safety margin for adenocarcinomas of the esophagogastric junction
Title of the study (Brief title)	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	Yasuaki Nagami
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Gastroenterology
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	Yasuaki Nagami
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 03 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019857