UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter collaborative retrospective study of POEM for achalasia
Acronym	Multicenter collaborative retrospective study of POEM for achalasia
Scientific Title	Multicenter collaborative retrospective study of POEM for achalasia
Scientific Title:Acronym	Multicenter collaborative retrospective study of POEM for achalasia
Region	Japan

Condition
Condition	Achalasia and esophageal motility disorders
Classification by specialty	Gastroenterology Gastrointestinal surgery Operative medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1)To verify short-term and long term outcome of POEM 2)To identify the risk factor of GERD after POEM
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of GERD after POEM The severity of GERD after POEM
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing POEM for esophageal achalasia at 12 facilities in Japan between September 2008 and March 2018
Key exclusion criteria	None
Target sample size	2000

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 Diseases 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 Faculty of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	8140180
Address	7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
TEL	092-801-1011
Homepage URL
Email	hiro.shiwaku@gmail.com

Sponsor
Institute	Digestive Diseases Center, Showa University Koto-Toyosu Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Department of Gastroenterological Surgery Fukuoka University Faculty of Medicine
Address	7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
Tel	09095675463
Email	hiro.shiwaku@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

Other administrative information
Date of disclosure of the study information	2019 Year 08 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	2000
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	2019 Year 02 Month 01 Day
Date of IRB	2019 Year 03 Month 06 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 07 Month 28 Day
Last modified on	2019 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042768