UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051308 |
|---|---|
| Receipt number | R000058525 |
| Scientific Title | Observational Study on the Qualification and Indication of Endoscopic Gastroesophageal Anti-Reflux Mucosal Resection Technique for Patients with Refractory Gastroesophageal Reflux Disease |
| Date of disclosure of the study information | 2023/06/09 |
| Last modified on | 2023/12/09 19:32:56 |
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Basic information
Public title
Observational Study on the Qualification and Indication of Endoscopic Gastroesophageal Anti-Reflux Mucosal Resection Technique for Patients with Refractory Gastroesophageal Reflux Disease
Acronym
Prospective Observational Study on Endoscopic Gastroesophageal Reflux Prevention
Scientific Title
Observational Study on the Qualification and Indication of Endoscopic Gastroesophageal Anti-Reflux Mucosal Resection Technique for Patients with Refractory Gastroesophageal Reflux Disease
Scientific Title:Acronym
Prospective Observational Study on Endoscopic Gastroesophageal Reflux Prevention
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease (GERD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal is to clarify in which backgrounds GERD patients can benefit from endoscopic anti-reflux mucosectomy and which techniques of endoscopic anti-reflux mucosectomy can improve GERD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients will be divided into effective and ineffective endoscopic treatment groups and compared on preoperative background factors and intraoperative findings.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients scheduled for endoscopic treatment for GERD
Key exclusion criteria
Study subjects deemed inappropriate by the principal investigator or physician in charge (cases who failed to complete GERD endoscopic treatment are not excluded from enrollment).
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ota |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Endoscopy Center
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
kazuhiro.ota@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ota |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Endoscopy Center
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
https://jpn-ga.jp/blog/ct_research-grant/8730/
kazuhiro.ota@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Gastroenterological Association
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 and Pharmaceutical University
Address
2-7, Daigaku-machi, Takatsuki, Osaka
Tel
072-683-1221
kazuhiro.ota@ompu.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
| 2023 | Year | 06 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Background investigation: gender, age, height, weight, history of gastric surgery (reconstruction method), acid secretion suppressant titer to control symptoms
Questionnaire (attached): F-scale questionnaire, GERD-Q score, GERD-HRQL, Pittsburgh Sleep Questionnaire, HADS, Dysphagia score
Endoscopic findings: Los Angeles classification, CO-SH scale, Hill classification, Prague classification
Esophageal manometry (Group H only): resting EGJ pressure (LES pressure), EGJ-CI, EGJ morphology
24-hour intraesophageal impedance/pH monitoring (Group H only)
Number of symptoms associated with reflux / total number of symptoms (Symptom Index)
Symptom-related reflux / total reflux (Symptom Sensitivity Index)
Esophageal acid exposure time (%), number of refluxes (acid, nonacid), DeMeester score, MNBI, PSPW index
Technique: ESD-G method of GERD endoscopic treatment (ESD only, EMR only, combined, mucosal resection site)
Adverse events: Gastrointestinal bleeding, obvious perforation or stenosis (inability to pass a general endoscope [9-11 mm tip] or inability to pass solid material), etc. during the first 3 years after surgery.
Evaluation
The effective group and the ineffective group will be divided into two groups, and preoperative background factors and intraoperative findings will be compared.
Management information
Registered date
| 2023 | Year | 06 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058525
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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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