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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028567
Receipt No. R000032686
Scientific Title Prospective study to evaluate the clinical outcome of POEM combined with endoscopic anti-reflux surgery.
Date of disclosure of the study information 2017/08/08
Last modified on 2018/02/11

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Basic information
Public title Prospective study to evaluate the clinical outcome of POEM combined with endoscopic anti-reflux surgery.
Acronym Endoscopic anti-reflux surgery and POEM
Scientific Title Prospective study to evaluate the clinical outcome of POEM combined with endoscopic anti-reflux surgery.
Scientific Title:Acronym Endoscopic anti-reflux surgery and POEM
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the clinical outcome and safety of POEM combined with endoscopic anti-reflux surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1: The reslut of multichannel intraluminal impedance pH monitoring(MII-pH)
2: endoscopic findings
3: symptoms
4: whether the patients needs PPI or not
in 2 months later and 1 year later from the surgery.
5: QERD-Q score and F-scale
Key secondary outcomes 1: The clinical outcome of POEM(Eckardt score, esophageal manometry, esophagography)
2: Adverse event due to surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 conventional POEM
Interventions/Control_2 adding endoscopic anti-reflux surgery
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who are planning to undergo POEM surgery, and who can recieve informed consent document.
Key exclusion criteria 1: severe achalasia (ex. sigmoid type)
2: non-achalasia
3: taking anti-thrombotic agents
4: who has severe complications(Diabetes, Heart disease, Strokes, Neurological disorder,
Psychosis, etc.)
5: a history of complications with anesthesia
6: pregnant and breast-feeding
7: who cannot withdraw PPI
8: consent can not be obtained
9: other inappropriate cases
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiro Inoue
Organization Showa University Koto Toyosu Hospital
Division name Digestive Disease Center
Zip code
Address 5-1-38 Toyosu Koto-ku, Tokyo, Japan
TEL 03-6204-6000
Email haruinoue777@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Ueno
Organization Showa University Koto Toyosu Hospital
Division name Digestive disease center
Zip code
Address 5-1-38 Toyosu Koto-ku, Tokyo, Japan
TEL 03-6204-6000
Homepage URL
Email akikoueno@med.showa-u.ac.jp

Sponsor
Institute Showa University Koto Toyosu Hospital
Institute
Department

Funding Source
Organization Showa University Koto Toyosu Hospital
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
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 昭和大学江東豊洲病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 08 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 08 Day
Last modified on
2018 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032686

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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