Endoscopic Resection Multicenter Registry
Endoscopic Resection: A Retrospective and Prospective Multicenter Registry
This is a retrospective and prospective multicenter registry to collect long-term data (1 year) on patients who have or will undergo Endoscopic resection such as EMR, ESD, EFTR, STER, etc. within the gastrointestinal tract for endoscopic treatment of early gastrointestinal neoplasms involving the resection of the superficial layers, mucosa and submucosa, of the tract wall.
Subjects will be consented for medical chart review.
The purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).
The registry will evaluate efficacy, technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this registry study.
調査の概要
状態
介入・治療
詳細な説明
Endoscopic resection can be an appropriate approach in early neoplasms, challenging adenomas or sub-epithelial lesions. Endoscopic resection can be considered as a less invasive approach than surgery. Moreover, endoscopic resection can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.
The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection, and EFTR (Endoscopic full-thickness resection). Clinical metrics will be recorded including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.
Currently, there is limited multi-center data on endoscopic resection outcomes in western populations.
Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at WCMC-NYPH.
The purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).
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、10065
- 募集
- Weill Cornell Medical College
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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 is considering undergoing endoscopic resection within 6 months, or has undergone clinically indicated endoscopic resection within the past 6 months
- Above or equal to 18 years of age.
Exclusion Criteria:
- Any patient who has not undergone or will undergo endoscopic resection
- 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 Resection
Patients undergoing Endoscopic Resection
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Any Endoscopic resection for Gastrointestinal disorders including neoplasms.
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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 |
---|---|---|
Number of participants with reduction in clinical symptoms
時間枠:6 months from procedure
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To assess resolution of symptoms of all Endoscopic resection procedures at 6 months
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6 months from procedure
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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 |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
時間枠:30 days post procedure
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Number of subjects with Adverse Events; Type, frequency and intensity of adverse events within 30 days of procedure
|
30 days post procedure
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of participants with successful completion of treatment
時間枠:30 days post procedure
|
Number of participants with successful completion of treatment
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30 days post procedure
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1701017930
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
Endoscopic Resectionの臨床試験
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Nantes University HospitalHospices Civils de Lyon; University Hospital, Angers; Rennes University Hospital; LA ROCHE SUR YON...完了