UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021843 |
|---|---|
| Receipt number | R000025082 |
| Scientific Title | A novel endoscopic submucosal dissection technique for proton pump inhibitor-refractory gastroesophageal reflux disease |
| Date of disclosure of the study information | 2016/04/09 |
| Last modified on | 2022/04/14 11:17:57 |
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Basic information
Public title
A novel endoscopic submucosal dissection technique for proton pump inhibitor-refractory gastroesophageal reflux disease
Acronym
ESD for GERD
Scientific Title
A novel endoscopic submucosal dissection technique for proton pump inhibitor-refractory gastroesophageal reflux disease
Scientific Title:Acronym
ESD for GERD
Region
| Japan |
Condition
Condition
gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We devised an endoscopic fundoplication procedure using endoscopic submucosal dissection (ESD) for the treatment of GERD (ESD-G). The aim of this study was to clarify
the effect and safety of ESD-G.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint was the improvement in
the rate of heartburn experienced by the patients following ESD-G.
Key secondary outcomes
The secondary endpoints were comparisons of the frequency scale for the symptoms
of GERD (FSSG), before and 6 months after the procedure, oral medication dose, LA classification of the endoscopic findings, and esophageal 24-h pH monitoring. The safety of ESD-G was also assessed.
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
encoscopic submucosal dissection
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males or females aged 20 years or older
2. Patients complaining of symptoms of gastroesophageal reflux disease on an inquiry sheet despite receiving PPI therapy for 8 weeks or more
3. Those with reflux esophagitis involving <3/4 of the circumference on endoscopy
4. Those in whom intra-esophageal pressure measurement and 24-hour esophageal pH monitoring were performed before surgery, and endoscopy, intra-esophageal pressure testing, and 24-hour esophageal pH monitoring are possible 1 month after surgery
5. Those from whom written informed consent regarding this procedure was obtained
Key exclusion criteria
1. Patients aged 19 years or younger
2. Those with reflux esophagitis involving more than 3/4 of the circumference on endoscopy
3. Those with a history of portal hypertension or esophageal varices
4. Those who have undergone gastric or esophageal surgery
5. Those with esophagostenosis or dysphagia
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhide |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Medical College
Division name
Second Department of Internal Medicine
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
TEL
072-683-1221
higuchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshihisa |
| Middle name | |
| Last name | Takeuchi |
Organization
Osaka Medical College
Division name
Endoscopy Center
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
TEL
072-683-1221
Homepage URL
in2097@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical College
Address
2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
Tel
072-683-1221
rinri@osaka-med.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://bmcgastroenterol.biomedcentral.com/track/pdf/10.1186/s12876-021-02022-x.pdf
Number of participants that the trial has enrolled
35
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 | 03 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 09 | Day |
Last modified on
| 2022 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025082
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
