Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders
Advanced Imaging for Diagnosing Pancreatico-biliary Disorders: A Multicenter Registry.
調査の概要
詳細な説明
Advanced imaging techniques such as SpyGlass or pCLE (probe-based Confocal laser endomicroscopy) using Cellvizio probes enable high sensitive and specific diagnosis of strictures or tumors in bile and pancreatic ducts. However, advanced endoscopists have only recently started to employ such techniques for diagnostic purposes. Hence we lack enough data to evaluate the sensitivity, specificity, accuracy, technical feasibility and safety of such imaging devices. Evaluation of these factors would help us compare them to conventional diagnostic options; and consequently help us identify appropriate advanced imaging techniques for biliary and pancreatic disorders and improve clinical management of patients.
The purpose of this registry is to record information and evaluate the impact of advanced imaging techniques on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by advanced imaging techniques.
This multi-center registry has been initiated:
- To document the impact of advanced imaging techniques in pancreatico-biliary disorders on the clinical management of pancreatico-biliary disorders including malignancies.
- To assess the sensitivity, specificity, accuracy, technical feasibility and safety of advanced imaging techniques in pancreatico-biliary disorders.
The registry will review and document:
- All patients who have had advanced imaging done for pancreatico-biliary disorders.
- No subject intervention is involved in this study. Subject contact is not needed for database review.
Study Design at Secondary sites:
- Other sites must have either a database review protocol and/or a clinical trial that would collect data on advanced imaging done for pancreatico-biliary disorders prior to participating in the registry.
- These sites would have IRB approved protocols to collect and send advanced imaging procedure data to the primary site (WCMC). Additionally, the secondary study sites would mention WCMC as an entity that could receive PHI in their respective protocols and consent/HIPAA forms.
- All secondary study sites' IRB approvals will be sent to the primary/coordinating study center at WCMC. The primary center will then forward these IRB approvals to WCMC IRB as soon as they are received from the secondary study sites.
- Relevant IRB documentation will be maintained at both primary and secondary sites.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10021
- 募集
- Weill Cornell Medical College
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コンタクト:
- Monica R Gaidhane, MD
- 電話番号:646-962-4796
- メール:mog2012@med.cornell.edu
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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:
- Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.
- Above 18 years of age.
Exclusion Criteria:
- Any patient who has not undergone advanced imaging techniques for pancreatico-biliary disorders.
- Below 18 years of age.
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 |
介入・治療 |
---|---|
Endoscopic imaging
Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.
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Endoscopy involving advanced imaging techniques
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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 |
---|---|---|
Efficacy Profile
時間枠:1 year
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Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable analyses.
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1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Survival duration
時間枠:1 year or more
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Documentation of follow up diagnoses variable and survival duration (in days).
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1 year or more
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Efficacy
時間枠:1 year
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Documentation of technical success and clinical success rates.
Technical success will be recorded as procedure success and capturing of relevant advanced imaging.
Clinical success will be recorded as if a diagnosis was made based on the advanced imaging results.
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1 year
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Safety Profile
時間枠:30 days
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Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events.
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30 days
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Tyberg A, Xu MM, Gaidhane M, Kahaleh M. Second generation optical coherence tomography: Preliminary experience in pancreatic and biliary strictures. Dig Liver Dis. 2018 Nov;50(11):1214-1217. doi: 10.1016/j.dld.2018.05.019. Epub 2018 Jun 8.
- Karia K, Waxman I, Konda VJ, Gress FG, Sethi A, Siddiqui UD, Sharaiha RZ, Kedia P, Jamal-Kabani A, Gaidhane M, Kahaleh M. Needle-based confocal endomicroscopy for pancreatic cysts: the current agreement in interpretation. Gastrointest Endosc. 2016 May;83(5):924-7. doi: 10.1016/j.gie.2015.08.080. Epub 2015 Sep 14.
- Karia K, Jamal-Kabani A, Gaidhane M, Tyberg A, Sharaiha RZ, Kahaleh M. Probe-Based Confocal Endomicroscopy in Primary Sclerosing Cholangitis: Not All Inflammatory Strictures Are the Same. Dig Dis Sci. 2016 Jan;61(1):283-6. doi: 10.1007/s10620-015-3827-1. Epub 2015 Aug 2.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。
Diagnosis of a Pancreaticobiliary Disorderの臨床試験
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