UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048384 |
|---|---|
| Receipt number | R000055116 |
| Scientific Title | Endoscopic evaluation for gastrointestinal function by measuring intra-gastrointestinal pressure and CO2 injection volume. |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2024/02/28 19:21:36 |
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Basic information
Public title
Endoscopic evaluation for gastrointestinal function
Acronym
Endoscopic evaluation for gastrointestinal function
Scientific Title
Endoscopic evaluation for gastrointestinal function by measuring intra-gastrointestinal pressure and CO2 injection volume.
Scientific Title:Acronym
Endoscopic evaluation for gastrointestinal function by measuring intra-gastrointestinal pressure and CO2 injection volume.
Region
| Japan |
Condition
Condition
Functional gastrointestinal disorders(FGIDs), Esophageal motility disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although evaluation methods for functional gastrointestinal diseases have been developed in recent years, they are still not very versatile and are highly invasive.
In this study, we aimed to clarify the usefulness of intra-intestinal pressure and CO2 volume measurements in the evaluation of gastrointestinal function using endscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of gastric distensibility evaluated by intragastric pressure and CO2 injection volume and symptom scale in patients with functional dyspepsia and controls
Key secondary outcomes
-A study of gastric distensibility and lower esophageal sphincter function evaluated by intragastric pressure and CO2 injection volume in patients with gastroesophageal reflux disease(GERD).
-A study of gastric distensibility and lower esophageal sphincter function evaluated by intragastric pressure and CO2 injection volume in patients with functional heartburn.
-A study of esophageal distensibility evaluated by intra-esophageal pressure and CO2 injection volume in patients with esophageal motility disorders.
-A comparative study of gastric distensibility and contrast-enhanced gastric capacity in patients with functional dyspepsia and controls.
-A study of Evaluation for gastrointestinal hypersensitivity using intra-gastrointestinal pressure, CO2 injection volume, and BIS(Bispectral Index).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
In patients scheduled for endoscopy, a gastrointestinal pressure and flow measuring device is attached to the endoscope to evaluate gastrointestinal tract function.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients scheduled endoscopy in our hospital for symptoms of suspected FGIDs.
2.Patients with no abnormalities at esophagogastroduodenography(EGD) in this study.
3.Patients who can understand the explanation of this research plan and can give their own consent.
4.Patients who are 20 years old or older at the time of obtaining consent.
Key exclusion criteria
1.Pregnant women or patients who may be pregnant.
2.Patients with a history of gastrointestinal surgery(excluding endoscopic procedures).
3.Patients requiring the use of spasmolytic drug ( butylscopolamine, glucagon) during endoscopy.
4.Patients in poor general condition due to severe cardiopulmonary impairment.
5.Patients who are unable to understand examination procedures or express symptoms due to mental illness or cognitive dysfunction.
6.Patients who are judged inappropriate by physician participating in this trial
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hruei |
| Middle name | |
| Last name | Ogino |
Organization
Graduate School of Medicine, Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
0926425286
ogino.haruei.600@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Wada |
Organization
Graduate School of Medicine, Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
0926425286
Homepage URL
wada.masafumi.710@m.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Kyushu University
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
Kyushu University Institutional Review Board for Clinical Trials
Address
Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
| 2022 | Year | 07 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055116
