UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026550 |
|---|---|
| Receipt number | R000030487 |
| Scientific Title | A study on clinical outcomes of endoscopic submucosal dissection for superficial neoplasms in the cervical esophagus |
| Date of disclosure of the study information | 2017/03/15 |
| Last modified on | 2019/03/19 17:32:50 |
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Basic information
Public title
A study on clinical outcomes of endoscopic submucosal dissection for superficial neoplasms in the cervical esophagus
Acronym
Clinical outcomes of endoscopic submucosal dissection in the cervical esophagus
Scientific Title
A study on clinical outcomes of endoscopic submucosal dissection for superficial neoplasms in the cervical esophagus
Scientific Title:Acronym
Clinical outcomes of endoscopic submucosal dissection in the cervical esophagus
Region
| Japan |
Condition
Condition
esophageal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the clinical outcomes of endoscopic submucosal dissection including the cervical esophagus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
en bloc resection of tumor
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who diagnosed with esophageal superficial neoplasms.
Patients with neoplasms extending to the cervical esophagus.
Patients who underwent endoscopic submucosal dissection in Kobe university hospital between July 1,2003 and November 31,2015.
Key exclusion criteria
Patients who had previously undergone surgery on the pharyngolarynx or esophagus.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Toyonaga |
Organization
Kobe University Hospital
Division name
Department of Endoscopy
Zip code
650-0052
Address
7-5-2,Kusunoki-Cho, Chuo-Ku,Kobe-City,Hyogo
TEL
078-382-6305
toyonaga@bf7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Ryusuke |
| Middle name | |
| Last name | Ariyoshi |
Organization
Kobe University Hospital
Division name
Department of Endoscopy
Zip code
650-0052
Address
7-5-2,Kusunoki-Cho, Chuo-Ku,Kobe-City,Hyogo
TEL
078-382-6305
Homepage URL
arysrsk@gmail.com
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital Clinical & Translational Reseach Center
Address
7-5-2,Kusunoki-Cho, Chuo-Ku,Kobe-City,Hyogo
Tel
078-382-6669
kansatsu@med.kobe-u.ac.jp
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
| 2017 | Year | 03 | Month | 15 | 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
26
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
Terminated
Date of protocol fixation
| 2016 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study. The clinical data of patients were obtained from the medical records of our institution.
Management information
Registered date
| 2017 | Year | 03 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030487
