UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Unraveling the pathogenesis and relationship among manometric subtype of esophageal achalasia and achalasia-related disease, using cytokine profile expressed in the muscle layer
Title of the study (Brief title)	Unraveling the pathogenesis and relationship among manometric subtype of esophageal achalasia using cytokine profile expressed in the muscle layer
Region	Japan

Condition
Condition	Esophageal achalasia
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the pathogenesis and the relationship among esophageal achalasia subtype
Basic objectives2	Others
Basic objectives -Others	Unraveling the pathogenesis Associated factor
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The expression of cytokine and transcription factor related to Th1/Th2/Th17 immunological response in esophageal achalasia and achalasia-related disease
Key secondary outcomes	The relationship between achalasia subtype and the pattern of cytokine expression in esophageal muscle layer The relationship between achalasia subtype and the esophageal / intestinel flora Pathological diference among esophageal achalasia subtype

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 with esophageal achalasia and achalasia-related disease Patients who are aged 20 years or older at the time of acquisition
Key exclusion criteria	Patients who reject this research
Target sample size	120

Research contact person
Name of lead principal investigator	Eikichi Ihara
Organization	Graduate school of Medical Sciences, Kyushu Universit
Division name	Department of Medicine and Bioregulatory
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL	092-642-5286
Email	eikichi@intmed3.med.kyushu-u.ac.jp

Public contact
Name of contact person	Eikichi Ihara, Koji Mukai
Organization	Graduate school of Medical Sciences, Kyushu University
Division name	Department of Medicine and Bioregulatory
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL	092-642-5286
Homepage URL
Email	eikichi@intmed3.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Medicine and Bioregulatory, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	JSPS
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Digestive Disease Center, Showa University koto Toyosu Hospital
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	2017 Year 06 Month 29 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 28 Day
Anticipated trial start date	2017 Year 04 Month 10 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	Unpublished
URL releasing results
Results
Other related information	Patient group: We collect the biopsy samples of mucosal and muscular tissues from patients with achalasia, and obtain the stools to analyze gut bacterial flora. Control group 1: We collect the biopsy samples of mucosal and muscular tissues from patients with esophageal cancer during esophagectomy. Control group 2: We collect the biopsy samples of mucosal tissues from patients without esophageal motility disorder, and obtain the stools to analyze gut bacterial flora.

Management information
Registered date	2017 Year 06 Month 29 Day
Last modified on	2017 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032070