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UMIN-CTR 臨床試験登録情報の閲覧 |
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利用者名: | UMIN ID: |
試験進捗状況 | 一般募集中/Open public recruiting |
UMIN試験ID | UMIN000048146 |
受付番号 | R000054814 |
科学的試験名 | 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 |
一般公開日(本登録希望日) | 2022/06/23 |
最終更新日 | 2022/06/23 |
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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対象疾患/Condition | |||
対象疾患名/Condition | 健常者 | healthy volunteer | |
疾患区分1/Classification by specialty |
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疾患区分2/Classification by malignancy | 悪性腫瘍以外/Others | ||
ゲノム情報の取扱い/Genomic information | いいえ/NO |
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 | ||
試験のフェーズ/Developmental phase |
評価/Assessment | ||
主要アウトカム評価項目/Primary outcomes | Distension-contraction plot法における、健常者の正常値・正常所見を構築する | Establish the normative thresholds and normal findings for healthy volunteers in the Distension-contraction plot method. |
副次アウトカム評価項目/Key secondary outcomes | Distension-contraction plot法の結果と食道X線検査(おにぎり食道造影検査)所見の関連 | Relationship between Distension-contraction plot method and esophageal radiography (onigiri esophagography) findings |
基本事項/Base | ||
試験の種類/Study type | 介入/Interventional |
試験デザイン/Study design | ||
基本デザイン/Basic design | 単群/Single arm | |
ランダム化/Randomization | 非ランダム化/Non-randomized | |
ランダム化の単位/Randomization unit | ||
ブラインド化/Blinding | オープン/Open -no one is blinded | |
コントロール/Control | 群内/Self control | |
層別化/Stratification | ||
動的割付/Dynamic allocation | ||
試験実施施設の考慮/Institution consideration | ||
ブロック化/Blocking | ||
割付コードを知る方法/Concealment |
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 |
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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 | ||||
介入3/Interventions/Control_3 | ||||
介入4/Interventions/Control_4 | ||||
介入5/Interventions/Control_5 | ||||
介入6/Interventions/Control_6 | ||||
介入7/Interventions/Control_7 | ||||
介入8/Interventions/Control_8 | ||||
介入9/Interventions/Control_9 | ||||
介入10/Interventions/Control_10 |
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 |
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 |
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 |
責任研究者/Research contact person | ||||||||||||||
責任研究者/Name of lead principal investigator |
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所属組織/Organization | 九州大学大学院医学研究院 | Graduate School of Medicine, Kyushu University | ||||||||||||
所属部署/Division name | 病態制御内科学 | Department of Medicine and Bioregulatory Science | ||||||||||||
郵便番号/Zip code | 8128582 | |||||||||||||
住所/Address | 福岡県福岡市東区馬出3-1-1 | 3-1-1 Maidashi, Higashi-ku, Fukuoka | ||||||||||||
電話/TEL | 0926425286 | |||||||||||||
Email/Email | ogino.haruei.600@m.kyushu-u.ac.jp |
試験問い合わせ窓口/Public contact | ||||||||||||||
試験問い合わせ窓口担当者/Name of contact person |
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組織名/Organization | 九州大学大学院医学研究院 | Graduate School of Medicine, Kyushu University | ||||||||||||
部署名/Division name | 病態制御内科学 | Department of Medicine and Bioregulatory Science | ||||||||||||
郵便番号/Zip code | 8128582 | |||||||||||||
住所/Address | 福岡県福岡市東区馬出3-1-1 | 3-1-1 Maidashi, Higashi-ku, Fukuoka | ||||||||||||
電話/TEL | 0926425286 | |||||||||||||
試験のホームページURL/Homepage URL | ||||||||||||||
Email/Email | tsuru.hirotaka.436@m.kyushu-u.ac.jp |
実施責任組織/Sponsor | ||
機関名/Institute | 九州大学 | Graduate School of Medicine, Kyushu University
Department of Medicine and Bioregulatory Science |
機関名/Institute (機関選択不可の場合) |
病態制御内科学 | |
部署名/Department |
研究費提供組織/Funding Source | ||
機関名/Organization | 九州大学 | Graduate School of Medicine, Kyushu University
Department of Medicine and Bioregulatory Science |
機関名/Organization (機関選択不可の場合) |
病態制御内科学 | |
組織名/Division | ||
組織の区分/Category of Funding Organization | その他/Other | |
研究費拠出国/Nationality of Funding Organization |
その他の関連組織/Other related organizations | ||
共同実施組織/Co-sponsor | ||
その他の研究費提供組織/Name of secondary funder(s) |
IRB等連絡先(公開)/IRB Contact (For public release) | ||
組織名/Organization | 九州大学病院臨床試験倫理審査委員会 | Kyushu University Institutional Review Board for Clinical Trials |
住所/Address | 福岡県福岡市東区馬出3-1-1 | 3-1-1 Maidashi, Higashi-ku, Fukuoka |
電話/Tel | 0926425082 | |
Email/Email | byskenkyu@jimu.kyushu-u.ac.jp |
他機関から発行された試験ID/Secondary IDs | ||
他機関から発行された試験ID/Secondary IDs | いいえ/NO | |
試験ID1/Study ID_1 | ||
ID発行機関1/Org. issuing International ID_1 | ||
試験ID2/Study ID_2 | ||
ID発行機関2/Org. issuing International ID_2 | ||
治験届/IND to MHLW |
試験実施施設/Institutions | ||
試験実施施設名称/Institutions |
その他の管理情報/Other administrative information | ||||||||
一般公開日(本登録希望日)/Date of disclosure of the study information |
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関連情報/Related information | ||
プロトコル掲載URL/URL releasing protocol | ||
試験結果の公開状況/Publication of results | 未公表/Unpublished |
結果/Result | ||
結果掲載URL/URL related to results and publications | ||
組み入れ参加者数/Number of participants that the trial has enrolled | ||
主な結果/Results | ||
主な結果入力日/Results date posted | ||
結果掲載遅延/Results Delayed | ||
結果遅延理由/Results Delay Reason | ||
最初の試験結果の出版日/Date of the first journal publication of results | ||
参加者背景/Baseline Characteristics | ||
参加者の流れ/Participant flow | ||
有害事象/Adverse events | ||
評価項目/Outcome measures | ||
個別症例データ共有計画/Plan to share IPD | ||
個別症例データ共有計画の詳細/IPD sharing Plan description |
試験進捗状況/Progress | ||||||||
試験進捗状況/Recruitment status | 一般募集中/Open public recruiting | |||||||
プロトコル確定日/Date of protocol fixation |
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倫理委員会による承認日/Date of IRB |
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登録・組入れ開始(予定)日/Anticipated trial start date |
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フォロー終了(予定)日/Last follow-up date |
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入力終了(予定)日/Date of closure to data entry | ||||||||
データ固定(予定)日/Date trial data considered complete | ||||||||
解析終了(予定)日/Date analysis concluded |
その他/Other | ||
その他関連情報/Other related information |
管理情報/Management information | ||||||||
登録日時/Registered date |
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最終更新日/Last modified on |
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閲覧ページへのリンク/Link to view the page | |
URL(日本語) | https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000054814 |
URL(英語) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054814 |
研究計画書 | |
登録日時 | ファイル名 |
研究症例データ仕様書 | |
登録日時 | ファイル名 |
研究症例データ | |
登録日時 | ファイル名 |