UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Esophageal motor activity and symptoms before and after endoscopic resection
Title of the study (Brief title)	Effects of resection on esophageal motility
Region	Japan

Condition
Condition	Esophageal motility disorder
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to investigate the influence of endoscopic resection on esophageal motility obtained before and after resection.
Basic objectives2	Others
Basic objectives -Others	Relationship between dysphagia and esophageal motility
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparision of esophageal motility before and after endoscopic resection.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Esophageal neoplasms which are performed endoscopic resection
Key exclusion criteria	esophageal stenosis case post-surgery of esophagus
Target sample size	20

Research contact person
Name of lead principal investigator	Hironobu Mikami
Organization	Shimane University Faculty of Medicine
Division name	Second Department of Internal Medicine
Address	89-1, Enya-cho, Izumo, Shimane, Japan
TEL	+81-853-20-2190
Email	d_h_m202@med.shimane-u.ac.jp

Public contact
Name of contact person	Hironobu Mikami
Organization	Shimane University Faculty of Medicine
Division name	Second Department of Internal Medicine
Address	89-1, Enya-cho, Izumo, Shimane, Japan
TEL	+81-853-20-2190
Homepage URL
Email	d_h_m202@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 27 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 05 Month 28 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Esophageal motility following endoscopic resection is temporarily reduced regardless of the resection method, though recovers after re-epithelialization.

Management information
Registered date	2018 Year 03 Month 27 Day
Last modified on	2018 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036444