UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030250 |
|---|---|
| Receipt number | R000034517 |
| Scientific Title | Efficacy of circumference esophageal myotomy for achalasia with chest pain |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/06/08 17:18:10 |
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Basic information
Public title
Efficacy of circumference esophageal myotomy for achalasia with chest pain
Acronym
Circumference esophageal myotomy for achalasia
Scientific Title
Efficacy of circumference esophageal myotomy for achalasia with chest pain
Scientific Title:Acronym
Circumference esophageal myotomy for achalasia
Region
| Japan |
Condition
Condition
Achalasia
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the therapeutic effects of circumference esophageal myotomy for achalasia with chest pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement for chest pain at 3 months after surgery.
Key secondary outcomes
1. Safety of surgery
2. Passage of the esophagus by Timed Barium Esophagogram at 3 months after surgery.
3. Incidence rate of post-operative reflux esophagitis at 3 months after surgery.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Circumference esophageal 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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients of achalasia with chest pain
Key exclusion criteria
Age < 20 years or 70 >
pregnant women and women suspected of being pregnant or breast-feeding woman
Prior surgery for achalasia
Prior surgery for esophagus and stomach
Liiver cirrhosis and/or esophageal varices
Doctor's decision
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Yano |
Organization
The Jikei University School of Medicine
Division name
Dept. of Gastrointestinal Surgery
Zip code
105-8461
Address
3-25-8, Nishishimbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
f-yano@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Yano |
Organization
The Jikei University School of Medicine
Division name
Dept. of Gastrointestinal Surgery
Zip code
105-8461
Address
3-25-8, Nishishimbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Homepage URL
f-yano@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dept. of Gastrointestinal Surgery, 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)
IRB Contact (For public release)
Organization
The Ethics committee of The Jikei University School of Medicine for Biomedical Research
Address
3-25-8, Nishishimbashi, Minato-ku, Tokyo, Japan
Tel
03-3433-1111
notify@bvits.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
| 2020 | Year | 04 | 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
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | 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 | 12 | Month | 04 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034517
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/06/06 | 研究計画書第5版.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
