Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle (MUCIN)
Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.
The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.
調査の概要
詳細な説明
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.
We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield. Each patient will be randomized to FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90095
- UCLA Medical Center
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San Francisco、California、アメリカ、94117
- California Pacific Medical Center
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Florida
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Tampa、Florida、アメリカ、33612
- Moffit Cancer 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:
- 3.1.1 All patients referred for EUS tissue sampling who provide informed consent
Exclusion Criteria:
- 3.2.1 Coagulopathy which is not corrected
3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB
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:クロスオーバー割り当て
- マスキング:なし(オープンラベル)
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:Fine needle aspiration
fine needle aspiration
|
Fine needle aspiration
他の名前:
FNB
他の名前:
|
アクティブコンパレータ:Fine needle biopsy
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Fine needle aspiration
他の名前:
FNB
他の名前:
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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 Yield of EUS-FNB and EUS-FNA
時間枠:1 year
|
The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled.
This will be expressed as a percentage.
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB
時間枠:1 year
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The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist.
This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question.
This will be expressed as a percentage and compared between FNA and FNB
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1 year
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Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)
時間枠:1 yr
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As above.
Crossover to FNA or FNB occurs after 3 passes without adequate material
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1 yr
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Srinadh Komanduri、Northwestern University
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 (実際)
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
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。
膵臓癌の臨床試験
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Washington University School of MedicineUniversity of Oklahoma Medical Center; Northwestern University Chicago Illinois; Saint Luke's...完了
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Fine needle aspirationの臨床試験
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Foundation for Liver ResearchCook Ireland, Ltd.完了膵臓の腫瘤 | リンパ節フランス, スウェーデン, イスラエル, ベルギー, オーストラリア, アメリカ, イタリア, 日本, オランダ, スペイン