臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 21, 2025
Last modified on	Feb. 21, 2025
Trial ID	jRCT1050240276

Scientific Title	Study of Stricture Symptoms after Endoscopic Submucosal Dissection of the Esophagus (Single-center Prospective Observational Study)
Public Title	Study on Symptoms of Esophageal Stricture

Contact for Scientific Queries	Name	Ishihara Ryu
	Affiliation	Osaka International Cancer Institute
	Address	3-1-69, Otemae, Chuo-ku, Osaka, Japan
	Telephone	+81-6-6945-1181
	E-mail	ryu1486@gmail.com
Contact for Public Queries	Name	Morita Muneshin
	Affiliation	Osaka International Cancer Institute
	Address	3-1-69, Otemae, Chuo-ku, Osaka, Japan
	Telephone	+81-6-6945-1181
	E-mail	muneshin.m7@gmail.com

Recruitment status	Recruiting

Study Design
Anticipated date of first enrollment		Jan. 01, 2025
Actual date of first enrollment		Jan. 01, 2025
Target sample size		250
Study Type		Observational



	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Cases that meet selection criteria 1 or 2 and do not fall under any of the exclusion criteria will be considered eligible cases. In addition, patients will not be registered more than once. <Selection Criteria> 1 Patients with a post-esophageal ESD ulcer base of more than 1/2 circumference 2 Patients who have undergone endoscopic balloon dilation (EBD) for post-esophageal ESD stricture
	Exclusion Criteria	<Exclusion criteria> 1 Patients with other causes of stenosis other than post-esophageal ESD stenosis 2 Patients with a history of head and neck surgery (excluding local resection) or radiation exposure 3 Patients with a history of esophageal or gastric surgery or radiation exposure 4 Patients with a stenosis of more than 2 cm 5 Patients under 18 years of age at the time of registration 6 Patients who do not give written consent to participate in the study 7 Patients who are judged by the principal investigator or the person in charge of the study to be unsuitable as subjects
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Esophageal Neoplasms
Intervention(s)		N/A
Health Condition(s) Keyword		esophagus
Intervention(s) Keyword		N/A
Health Condition(s) Code		D004938
Intervention(s) Code		N/A
Primary Outcome(s)		Relationship between stenosis diameter and EAT-10
Secondary Outcome(s)		The relationship between the stenosis diameter and dysphagia score, factors related to stenosis symptoms, and the relationship between the stenosis diameter and each item on the EAT-10

Primary Sponsor	N/A

Source of Monetary Support	FUJIFILM Corporation
Secondary Sponsor	Not applicable

Name of Certified Review Board	Osaka Prefectural Hospital Organization, Osaka International Cancer Institute, Ethics Committee for Clinical Research
Address	3-1-69, Otemae, Chuo-ku, Osaka, Japan, Osaka
Telephone	+81-6-6945-1181
E-Mail	rinri01@opho.jp
Approval Status	Approval
Date of approval	Nov. 21, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none