UMIN-CTR Clinical Trial

Basic information
Public title	Peroral endoscopic myotomy for the treatment of achalasia: prospective multicenter study in Japan
Acronym	POEM for achalasia : prospective multicenter study in Japan
Scientific Title	Peroral endoscopic myotomy for the treatment of achalasia: prospective multicenter study in Japan
Scientific Title:Acronym	POEM for achalasia : prospective multicenter study in Japan
Region	Japan

Condition
Condition	Esophageal achalasia
Classification by specialty	Medicine in general Surgery in general Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the efficacy and safety of POEM for the treatment of patients with achalasia prospectively in multiple center in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Treatment success of POEM procedure at one year Treatment successful defined Eckardt score<3 and 3.
Key secondary outcomes	･Adverse event related to POEM procedure ･Treatment success of POEM procedure at three months and two years ･Postoperative GERD ･Pressure of lower esophageal sphincter ･Time of procedure time ･Continuous use of proton pump inhibitor

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Peroral Endoscopic myotomy (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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patient who are diagnosed achalasia or related motility disorders, and considered the indication of POEM.
Key exclusion criteria	(1) The patients unable to undergo general anesthesia (2) The patients whom attending doctor consider inappropriate
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Haruhiro Middle name Last name Inoue
Organization	Showa University Koto-Toyosu Hospital
Division name	Digestive Disease Center
Zip code	135-8577
Address	Toyosu5-1-38, Koto-Ku, Tokyo, 135-8577, Japan
TEL	03-6204-6064
Email	haruinoue777@yahoo.co.jp

Public contact
Name of contact person	1st name Hironari Middle name Last name Shiwaku
Organization	Fukuoka University Hospital
Division name	Department of Gastroenterological Surgery
Zip code	814-0180
Address	7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
TEL	092-801-1011
Homepage URL
Email	poem.fukuoka@gmail.com

Sponsor
Institute	Showa University Koto-Toyosu Hospital
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	Fukuoka University Hospital
Address	7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
Tel	092-801-1011
Email	poem.fukuoka@gmail.com

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	昭和大学江東豊洲病院（東京都） 福岡大学病院（福岡県）　 新潟大学医歯学総合病院（新潟県）　　　　　　　　　　 長崎大学病院（長崎県）　　　　　　　　　　　　　 　　 東北大学病院（宮城県）　　　　　　　　　　　　　　　　　 神戸大学医学部附属病院（兵庫県）　　　　　　　　　 ハートライフ病院（沖縄県）　　　　　　　　　　　　　　　　 大分大学医学部附属病院（大分県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 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	233
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	No longer recruiting
Date of protocol fixation	2016 Year 01 Month 13 Day
Date of IRB	2016 Year 03 Month 17 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 03 Month 19 Day
Last modified on	2019 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024758

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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