pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture (FOCUS)
調査の概要
状態
詳細な説明
This trial aims at evaluating the performance diagnosis of pCLE for the detection of bile duct cancer, in patients with indeterminate biliary stricture when associated with other diagnostic information.
The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone or ERCP with tissue sampling, by improving the sensitivity of detection and by providing a real-time diagnosis.
Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary duct lesions will be compared for the combination of ERCP alone, endomicroscopy plus ERCP imaging, and ERCP plus endomicroscopy plus tissue sampling. These information will be reviewed retrospectively by a second physician.
These presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). Secondary objectives include collecting patient management recommendation. Yet, effective management recommendation is left as the discretion of the physician.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Connecticut
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New Haven、Connecticut、アメリカ、06510
- Yale New Haven Hospital
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New York
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New york、New York、アメリカ、10065
- New York Presbyterian Weill Cornell Medical Center
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh Medical Center
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Washington
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Seattle、Washington、アメリカ、98111
- Virginia Mason Medical Center
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Roma、イタリア、00168
- Policlinico Univertitario Agostino Gemelli
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Marseille、フランス、13000
- Institut Paoli Calmettes
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Male or female > 18 years of age
- Indicated for ERCP for indeterminate bile duct stricture
- Referral patients with indeterminate biliary stricture coming in for first ERCP procedure at referral institution or
- Patients who had previous non-diagnostic tissue sampling (brushing biopsies or EUS-FNA) taken during a previous ERCP or EUS-FNA for an indeterminate biliary stricture
- Willing and able to comply with study procedures and provide written informed consent to participate in the study
Exclusion Criteria:
- Subjects for whom ERCP procedures are contraindicated
- Known allergy to fluorescein dye
- Patients suffering Primary Sclerosing Cholangitis or chronic pancreatitis.
- Patients with post-transplant stricture
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
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
コホートと介入
グループ/コホート |
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pCLE
This trial will study only one group which will receive a standard ERCP procedure followed by pCLE
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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 |
|---|---|---|
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Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
時間枠：12 months
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Evaluation of pCLE diagnostic performance for the diagnosis of indeterminate biliary stricture (ie.
number of patients accurately diagnosed) when associated with other diagnostic information The following calculations will be conducted: sensitivity, specificity, positive and negative predictive values, Accuracy
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12 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
時間枠：12 months follow-up
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12 months follow-up
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Adam Slivka, MD、University of Pittsburh Medical Center
出版物と役立つリンク
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
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。