UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028567 |
|---|---|
| Receipt number | 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 | 2020/08/18 12:26:28 |
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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 | Haruhiro |
| Middle name | |
| Last name | Inoue |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Disease Center
Zip code
1358577
Address
5-1-38 Toyosu Koto-ku, Tokyo, Japan
TEL
03-6204-6000
haru.inoue@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Toshimori |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive disease center
Zip code
1358577
Address
5-1-38 Toyosu Koto-ku, Tokyo, Japan
TEL
03-6204-6000
Homepage URL
akikoueno@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Koto Toyosu Hospital
Institute
Department
Personal name
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
Showa University Koto Toyosu Hospital
Address
5-1-38, Toyosu, Koto-ku, Tokyo, Japan
Tel
+81352046000
th_irb@ofc.showa-u.ac.jp
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
| 2017 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
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
| 2020 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032686
