| 基本情報/Basic information |
| 一般向け試験名/Public title |
健常者におけるDistension-contraction plot法と食道X線検査を用いた食道体部の蠕動運動評価
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Evaluation of peristalsis in the esophageal body using Distension-contraction plot method and esophageal radiography (onigiri esophagography) in healthy volunteers. |
| 一般向け試験名略称/Acronym |
健常者におけるDistension-contraction plot法と食道X線検査を用いた食道体部の蠕動運動評価
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Evaluation of peristalsis in the esophageal body using Distension-contraction plot method and esophageal radiography (onigiri esophagography) in healthy volunteers. |
| 科学的試験名/Scientific Title |
健常者におけるDistension-contraction plot法と食道X線検査を用いた食道体部の蠕動運動評価
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Evaluation of peristalsis in the esophageal body using Distension-contraction plot method and esophageal radiography (onigiri esophagography) in healthy volunteers. |
| 科学的試験名略称/Scientific Title:Acronym |
健常者におけるDistension-contraction plot法と食道X線検査を用いた食道体部の蠕動運動評価
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Evaluation of peristalsis in the esophageal body using Distension-contraction plot method and esophageal radiography (onigiri esophagography) in healthy volunteers. |
| 試験実施地域/Region |
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| 目的/Objectives |
| 目的1/Narrative objectives1 |
健常者の食道体部の蠕動運動を高解像度食道内圧検査（Distension-contraction plot法）および食道X線検査で評価し、正常値・正常所見を構築すること。 |
To establish the normative thresholds and normal findings of peristalsis of the esophageal body in healthy volunteers using high-resolution manometry (Distension-contraction plot method) and esophageal radiography (onigiri esophagography). |
| 目的2/Basic objectives2 |
その他/Others |
| 目的2 -その他詳細/Basic objectives -Others |
Distension-contraction plot法と食道X線検査（おにぎり食道造影検査）所見の関連性を評価すること。 |
To evaluate the relationship between the Distension-contraction plot method and esophageal radiography (onigiri esophagography) findings. |
| 試験の性質1/Trial characteristics_1 |
その他/Others |
| 試験の性質2/Trial characteristics_2 |
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| 試験のフェーズ/Developmental phase |
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| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
予防・検診・検査/Prevention |
| 介入の種類/Type of intervention |
| 医療器具・機器/Device,equipment |
手技/Maneuver |
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| 介入1/Interventions/Control_1 |
食道X線検査（おにぎり食道造影検査）
約20mGyの放射線曝露を生じる。
高解像度食道内圧検査（Distension-contraction plot法）
経鼻的にカテーテルを挿入する必要があり、検査時の肉体的負担がある。
またtrendelenburg位（-15°）での水嚥下が必要であり誤嚥のリスクを伴う。
|
Esophageal radiography (onigiri esophagography)
Requires radiation exposure of about 20 mGy.
High-resolution manometry(Distension-contraction plot method)
The catheter must be inserted nasally, which is physically stressful during the examination.
It also requires water swallowing in the Trendelenburg position, which risks aspiration.
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| 介入2/Interventions/Control_2 |
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| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
以下の基準をすべて満たす健常者を対象とする。
（１）食道運動異常症を疑うような自覚症状がない対象者
（２）嚥下機能が正常であることを確認された対象者
（３）本研究計画について十分に理解し、本人による同意が可能な対象者
（４）同意取得時における年齢が満20歳以上65歳未満の対象者
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Healthy volunteers who meet all of the following criteria are eligible.
(1) Subjects with no subjective symptoms that would raise suspicion of esophageal motility disorders
(2) Subjects who have been confirmed to have normal swallowing function
(3) Subjects who fully understand this research protocol and are able to give informed consent
(4) Subjects who are between 20 and 65 years old at the time of obtaining consent
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| 除外基準/Key exclusion criteria |
以下のうちひとつでも該当する場合は対象から除外する。
（１）食道運動に影響を与えうる消化管運動機能改善薬（モサプリド、ドンペリドン、六君子湯、メトクロプラミド、イトプリド、アコファイド）を検査1ヵ月以内に内服している対象者
（２）上部消化管外科手術後の対象者
（３）妊婦又は妊娠の可能性のある対象者
（４）キシロカインやバリウムにアレルギーがある対象者
（５）重度の心肺機能低下などで全身状態が不良な対象者
（６）精神疾患や認知機能の低下により検査方法の理解や症状の聴取が困難な対象者
（７）登録前に悪性腫瘍などの器質的異常を診断されている対象者
（８）その他重篤な合併症など、試験担当者が不適切と判断した対象者
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Patients are excluded from the study if any one of the following criteria is applicable.
(1) Subjects who are taking drugs for improving gastrointestinal motility that may affect esophageal motility within 1 month of the examination
(2) Subjects who have undergone upper gastrointestinal surgery
(3) Pregnant women or subjects who may become pregnant
(4) Subjects who are allergic to Xylocaine or barium
(5) Subjects in poor general condition due to severe cardiopulmonary impairment, etc.
(6) Subjects who have difficulty understanding the examination protocol or listening to symptoms due to psychological disorders or cognitive impairment.
(7) Subjects who have been diagnosed with organic abnormalities such as malignant tumors before registration
(8) Subjects with other serious complications that are judged inappropriate by the investigator.
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| 目標参加者数/Target sample size |
30 |
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