UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of Per-Oral Endoscopic submucosal Myotomy (POEM) for achalasia
Title of the study (Brief title)	Safety and efficacy of Per-Oral POEM for achalasia
Region	Japan

Condition
Condition	Achalasia
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate a safety of POEM for achalasia
Basic objectives2	Others
Basic objectives -Others	To evaluate an efficacy of POEM for achalasia
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Intra- and/or Postoperative complications 2. Symptom sale; before and after 3. Timed Barium Esophagogram
Key secondary outcomes

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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients of achalasia who undergo surgery 2. Obtain patient's consent
Key exclusion criteria	1. Women who are or may be pregnant and nursing mothers 2. Patient who was diagnosed achalasia as an advanced sigmoid type 3. Patient who had prior surgery for achalasia 4. Patient who had prior surgery for esophagus and/or stomach 5. Patient who was diagnosed liver cirrhosis or esophageal varices 6. Patient who was judged inadequate to this study
Target sample size	15

Research contact person
Name of lead principal investigator	Fumiaki Yano
Organization	Department of Surgery, The Jikei University School of Medicine
Division name	Gastrointestinal Surgery
Address	3-25-8, Nishishimbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Email	f-yano@jikei.ac.jp

Public contact
Name of contact person	Fumiaki Yano
Organization	Department of Surgery, The Jikei University School of Medicine
Division name	Gastrointestinal Surgery
Address	3-25-8, Nishishimbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Homepage URL
Email	f-yano@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	The Jikei University School of Medicine
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	2017 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 10 Month 01 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

Management information
Registered date	2017 Year 05 Month 11 Day
Last modified on	2018 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031280