UMIN-CTR Clinical Trial

Basic information
Public title	Questionnaire study of a single institution on the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Acronym	Study of the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Scientific Title	Questionnaire study of a single institution on the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Scientific Title:Acronym	Study of the effectiveness of Peroral Endoscopic Myotomy (POEM) for esophageal achalasia
Region	Japan

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

Objectives
Narrative objectives1	study the usefulness of POEM for esophageal achalasia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of Eckardt score before and after treatment.
Key secondary outcomes

Base
Study type

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	Maneuver
Interventions/Control_1	intervention of POEM
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	a. Patients with esophageal achalasia which has a current symptoms. b. Patients had esophagus fluoroscopy and upper gastrointestinal endoscopy for diagnosis as esophageal acalasia. c. Esophageal pressure measurement is not necessarily performed. d. Treatment history (medicine, endoscopic balloon dilation, surgical history) does not matter. e. Achalasia form classification, the degree of dilation is not limited. f. Patientsdetermined to be reasonable for POEM in Gastroenterology Surgery Conference.
Key exclusion criteria	a. Patients have risk factors for POEM clinically. b. minors. c. Patients have no imformed consent of POEM.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Okada
Organization	Okayama University Hospital
Division name	Department of Endoscopy
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL	086-235-7219
Email	hiro@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yuusaku Sugihara
Organization	Okayama University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL	086-235-7219
Homepage URL
Email	y.sugi117@gmail.com

Sponsor
Institute	Okayama University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Okayama University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 01 Month 06 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
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	Completed
Date of protocol fixation	2016 Year 11 Month 18 Day
Date of IRB	2020 Year 11 Month 06 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2020 Year 11 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 01 Month 05 Day
Last modified on	2020 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018728