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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name