UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030250
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email f-yano@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.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


Contact us.