UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000030487