UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of esophageal motility in patient with esophageal tumor treated by esophageal endoscopic resection
Acronym	effect on esophageal motility by endoscopic resection
Scientific Title	Evaluation of esophageal motility in patient with esophageal tumor treated by esophageal endoscopic resection
Scientific Title:Acronym	effect on esophageal motility by endoscopic resection
Region	Japan

Condition
Condition	esophageal tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the esophageal motility using high-resolution manometry before and after EMR/ESD
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the esophageal motility before and after EMR/ESD
Key secondary outcomes

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	Device,equipment
Interventions/Control_1	We investigate HRM data which is performed before and after endoscopic resection.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who have esophageal neoplastic lesion, which is possible to resect endoscopically. In case of early cancer, the lesion is judged to resect curatively(no invasion to submucosal layer, Ly0, v0, HM0, VM0). Patients who agreed to study participants by documents.
Key exclusion criteria	1)Rejection of Informed Consent. 2)Serious hepatic disease, heart disease, respiratory disease. 3)Difficulty of catheterization due to narrow nasal cavity, pain or Laryngopharyngeal reflux. 3)Severe allergic constitution. 4)Patients judged to be inappropriate as object in our study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tsutomu Middle name Last name Takeda
Organization	Juntendo University faculty of Medicine
Division name	Department of Gastroenterology
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	t-takeda@juntendo.ac.jp

Public contact
Name of contact person	1st name Kenshi Middle name Last name Matsumoto
Organization	Juntendo University hospital
Division name	Department of Gastroenterology
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	kmatumo@juntendo.ac.jp

Sponsor
Institute	Department of Gastroenterology Juntendo University faculty of Medicine
Institute
Department

Funding Source
Organization	none
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	Juntendo University IRB
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel	0338133111
Email	t-takeda@juntendo.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	順天堂大学附属順天堂医院

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.hindawi.com/journals/grp/2018/3735473/
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	Main results already published
Date of protocol fixation	2014 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date	2014 Year 12 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 12 Month 03 Day
Last modified on	2022 Year 09 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018416