UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017120 |
|---|---|
| Receipt number | 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 18:12:52 |
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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
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
yasuaki-75@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019857
