Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses
Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses in Terms of Suction or Without Suction: Prospective Randomized Single Blinded Trial
調査の概要
詳細な説明
For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.
First hypothesis: There is difference in the diagnostic accuracy of pancreatic masses according to EUS-FNA with suction or without suction/ different number of to-and-fro motion.
Second hypothesis: There is difference in the amount of blood in samples obtained by EUS-FNA with suction or without suction/ different number of to-and-fro motion.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Seoul、大韓民国、138-736
- Asan Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age > 19 years Solid pancreatic mass lesions
Exclusion Criteria:
- Age < 19 years Coagulopathy Unable to consent
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:EUS-FNA with suction
EUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA with suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory.
|
For this prospective single-blinded randomized trial, two 10cc syringes was prepared.
Two syringe was provided as same performance.
However, one syringe is falsely made as suction syringe (fake one).
During EUS-FNA, two syringe is randomly assigned and loaded by a nurse.
Thus, operator was blinded which syringe is with suction or without suction.
他の名前:
|
アクティブコンパレータ:EUS-FNA without suction
EUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA without suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory.
|
EUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA without suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory.
他の名前:
For this prospective single-blinded randomized trial, two 10cc syringes was prepared.
Two syringe was provided as same performance.
However, one syringe is falsely made as suction syringe (fake one).
During EUS-FNA, two syringe is randomly assigned and loaded by a nurse.
Thus, operator was blinded which syringe is with suction or without suction.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Diagnostic accuracy
時間枠:1 year
|
The diagnostic accuracy of pancreatic masses at each sample according to EUS-FNA with suction or without suction/ different number of to-and-fro motion will be measured. Diagnostic accuracy of EUS-FNA with suction and 10, 15, and 20 to-and-fro motion vs.Diagnostic accuracy of EUS-FNA without suction and 10, 15, and 20 to-and-fro motion. |
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Blood contamination in each sample
時間枠:1 year
|
The amount of blood contamination at each sample according to EUS-FNA with suction or without suction/ different number of to-and-fro motion will be measured. The amount of blood contamination of EUS-FNA with suction and 10, 15, and 20 to-and-fro motion vs. The amount of blood contamination of EUS-FNA without suction and 10, 15, and 20 to-and-fro motion. |
1 year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Do Hyun Park, MD, PhD、Asan Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2012-0018
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
膵臓の腫瘤の臨床試験
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Washington University School of MedicineUniversity of Oklahoma Medical Center; Northwestern University Chicago Illinois; Saint Luke's...完了
EUS-FNA with suctionの臨床試験
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American Society for Gastrointestinal EndoscopyMidwest Biomedical Research Foundationわからない縦隔または腹腔内リンパ節腫脹、 | 膵臓腫瘤、 | 左副腎腫瘤、 | 消化管粘膜下病変、および | 肝臓の塊アメリカ
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University Hospital, Ghent完了
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McGill University Health Centre/Research Institute...完了
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Huazhong University of Science and Technologyわからない