UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026550
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email arysrsk@gmail.com

Sponsor
Institute Kobe University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030487

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.