UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Per-oral endoscopic myotomy for achalasia
Title of the study (Brief title)	Per-oral endoscopic myotomy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of anterior myotomy, posterior myotomy, and long myotomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Relapse-free survival
Key secondary outcomes	Intra and post-treatment morbidity, success rate, symptom score, manometry findings

Base
Study type	Interventional

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	Per-oral endoscopic myotomy
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	informed consent
Key exclusion criteria	general condition is not favorable for general anesthesia
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroki Sato
Organization	Niigata University Medical and Dental Hospital
Division name	Division of Gastroenterology
Address	757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL	+81-25-223-6161
Email	pyloki.sato@gmail.com

Public contact
Name of contact person	Hiroki Sato
Organization	Niigata University Medical and Dental Hospital
Division name	Division of Gastroenterology
Address	757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL	+81-25-223-6161
Homepage URL
Email	pyloki.sato@gmail.com

Sponsor
Institute	Niigata University Medical and Dental 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)

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	2015 Year 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 05 Day
Anticipated trial start date	2015 Year 01 Month 05 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	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29608597
Results
Other related information

Management information
Registered date	2015 Year 01 Month 05 Day
Last modified on	2018 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018729