| 対象疾患/Condition |
| 対象疾患名/Condition |
脂肪吸収障害を有する方, または下痢, 脂肪便, 体重減少, 貧血等を認め, 脂肪吸収障害が疑われる患者 |
Patients with impaired fat absorption, or those with diarrhea, fatty stools, weight loss, anemia, etc., and suspected of having impaired fat absorption. |
| 疾患区分1/Classification by specialty |
| 消化器内科学（消化管）/Gastroenterology |
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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 |
脂肪乳化食品を負荷し, 脂肪の吸収障害を呈する消化管疾患に特徴的な十二指腸粘膜の内視鏡所見を明らかにする. |
To clarify the endoscopic findings of the duodenal mucosa characteristic of gastrointestinal diseases with impaired fat absorption after loading with fat emulsified foods. |
| 目的2/Basic objectives2 |
その他/Others |
| 目的2 -その他詳細/Basic objectives -Others |
脂肪乳化食品負荷後に観察した胃粘膜や食道バレット上皮の内視鏡所見 (白色光非拡大観察, NBI非拡大観察, NBI併用拡大観察) の特徴を求める. |
stomach |
| 試験の性質1/Trial characteristics_1 |
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| 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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| 評価/Assessment |
| 主要アウトカム評価項目/Primary outcomes |
脂肪乳化食品負荷後に観察した脂肪吸収障害を呈する消化管疾患に特徴的な十二指腸粘膜の内視鏡所見を探索的に求める. |
To determine the endoscopic findings of the duodenal mucosa characteristic of gastrointestinal diseases with impaired fat absorption observed after fat emulsified food loading. |
| 副次アウトカム評価項目/Key secondary outcomes |
１. 脂肪乳化食品負荷後にNBI拡大内視鏡を用いて観察したWOS陽性の十二指腸粘膜と WOS陰性の十二指腸粘膜の形態学的特徴を求める.
２. 脂肪乳化食品負荷後に NBI拡大内視鏡を用いて観察したWOS陽性の十二指腸粘膜とWOS陰性の十二指腸粘膜の病理学的特徴を求める.
３. 脂肪乳化食品負荷後に観察した胃粘膜の内視鏡所見 (白色光非拡大観察, NBI非拡大観察, NBI併用拡大観察) の特徴を求める.
４. 脂肪乳化食品負荷後に観察した食道バレット上皮の内視鏡所見 (白色光非拡大観察, NBI非拡大観察, NBI併用拡大観察) の特徴を求める.
５. 以上の内視鏡所見の特徴と対象患者の臨床病理学的特徴との関連を求める．
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1) To determine the morphological characteristics of WOS-positive and WOS-negative duodenal mucosa observed by NBI magnification endoscopy after fat emulsified food loading will be determined.
2) To determine the pathological characteristics of WOS-positive and WOS-negative duodenal mucosa observed by NBI magnifying endoscopy after fatty emulsified food loading. 3) To determine the pathological characteristics of WOS-positive and WOS-negative duodenal mucosa observed by NBI magnifying endoscopy after fatty emulsified food loading.
3. to determine the characteristics of endoscopic findings of gastric mucosa (non-white light magnification, non-NBI magnification, and magnification with NBI) observed after fat emulsified food loading.
4) Determine the characteristics of endoscopic findings (non-magnified white light, non-magnified NBI, magnified NBI) of esophageal Barrett's epithelium observed after fat emulsified food loading.
5) To determine the relationship between the characteristics of the above endoscopic findings and the clinicopathological characteristics of the target patients.
|
| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
診断/Diagnosis |
| 介入の種類/Type of intervention |
|
| 介入1/Interventions/Control_1 |
同意が取得できた患者について, 検査当日検査 4時間前に脂肪乳化食品を摂取させる。摂取される脂肪乳化食品を下記に示す。
ロッテ「爽」 190ml
（原材料）
砂糖（外国製造、国内製造）、植物油脂、乳製品、果糖、卵黄（卵を含む）、乳等を主要原料とする食品、デキストリン、食塩／乳化剤、安定剤（増粘多糖類）、香料、アナトー色素
（組成）
エネルギー 230kcal たん白質 3.2g 脂肪 11.6g 炭水化物 28.4g
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Patients will be given fat emulsified food 4 hours prior to the test day. Fat emulsified foods to be consumed are listed below.
Lotte "Sou" 190ml
(Ingredients)
Sugar (manufactured outside Japan, manufactured in Japan), vegetable oils and fats, dairy products, fructose, egg yolks (including eggs), foods made mainly from milk, dextrin, salt/emulsifier, stabilizer (polysaccharide thickener), flavor, annatto color
(Composition)
Energy 230kcal Protein 3.2g Fat 11.6g Carbohydrate 28.4g
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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 |
1) 上部消化管内視鏡検査が必要ななんらかの消化管疾患を有する患者.
2) 20歳以上の患者.
3) 脂肪乳化食品の摂取が可能である患者．
4) 試験参加について文書による同意が得られた患者
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1) Patients with any kind of gastrointestinal disease that requires upper gastrointestinal endoscopy.
2) Patients over 20 years old.
3) Patients who are able to consume fat emulsified food.
4) Patients who have given written consent to participate in the study.
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| 除外基準/Key exclusion criteria |
1) 抗血栓薬や抗凝固薬, 抗血小板薬の服用により生検による出血リスクが高い患者.
2) 肝機能不全, 腎機能不全, 血液凝固異常などの基礎疾患により生検による出血リスクが高い患者.
3) 胃切除術の既往を有する患者.
4) 乳糖不耐症を有する患者.
5) その他, 試験責任医師または試験分担医師が本試験の実施に不適当と判断した患者.
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1) Patients at high risk of bleeding during biopsy due to antithrombotic, anticoagulant, or antiplatelet medication.
2) Patients at high risk of bleeding from biopsy due to underlying diseases such as hepatic insufficiency, renal insufficiency, or blood coagulation abnormalities.
3) Patients with a history of gastrectomy.
4) Patients with lactose intolerance.
5) Other patients who are judged inappropriate for this study by the investigator or sub-investigator.
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| 目標参加者数/Target sample size |
20 |
UMIN-CTR 臨床試験登録情報の閲覧