UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043956 |
|---|---|
| Receipt number | R000050205 |
| Scientific Title | Assessment of gastroesophageal reflux in patients without reflux symptoms |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2022/10/18 16:46:39 |
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Basic information
Public title
Assessment of gastroesophageal reflux in patients without reflux symptoms
Acronym
Assessment of gastroesophageal reflux in non-GERD patients
Scientific Title
Assessment of gastroesophageal reflux in patients without reflux symptoms
Scientific Title:Acronym
Assessment of gastroesophageal reflux in non-GERD patients
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess motility and reflux in patients without reflux symptoms using esophageal high-resolution impedance manometry (HRIM) and multiple intraluminal impedance-pH (MII-pH)
Basic objectives2
Others
Basic objectives -Others
To assess postprandial motility and reflux in patients without reflux symptoms using esophageal HRIM
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Esophageal acid exposure in MII-pH
Key secondary outcomes
1. Total reflux episodes including acid and non-acid in MII-pH
2. Total supragastric belching (SGB) episodes in MII-pH
3. Transient lower esophageal sphincter relaxation (TLESR) episodes in a postprandial period in HRIM
4. TLESR with reflux episodes in a postprandial period in HRIM
5. Postprandial SGB episodes in MII-pH
6. Postprandial rumination episodes in HRIM
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Esophageal high-resolution impedance manometry for one hour and multiple intraluminal impedance-pH monitoring for 24hours
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
(1)Participants aged between 20-70 years of either gender without reflux symptoms
(2)Performance Status (ECOG): 0-1
(3)Ability to understand the study information sheet and instructions and able to provide informed consent.
Key exclusion criteria
(1) Taking NSAIDs, steroids, immunosuppresive medications
(2) Prior abdominal surgery
(3) Prior chemotherapy
(4) Diabetes and collagen disease
(5) Taking acid suppressive medications and prokinetics
(6) Prior allergic reaction to Xylocain
(7) Difficulty in inserting a catheter due to narrow nasal cavity
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Koike |
Organization
Tohoku university
Division name
Gastroenterology
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
TEL
022-717-7171
tkoike@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Nakagawa |
Organization
Tohoku Univerisity
Division name
Gastroenterology
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
TEL
022-717-7171
Homepage URL
k.nakagawa221@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics committee of Tohoku University
Address
1-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
Tel
022-717-7000
rinri-esct@proj.med.tohoku.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
| 2021 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2021 | Year | 04 | Month | 17 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050205
| Research Plan | |
|---|---|
| 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 |
