The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer (Artery first)
調査の概要
詳細な説明
This is a prospective non-randomized trial with two study groups. The trial is designed to show if the ARTERY FIRST approach reduces the rate of R1 resections in patients undergoing surgery for cancer of the pancreatic head.
After the diagnosis of cancer of the pancreatic head by clinical, laboratory and imaging evaluation patients who are scheduled for resection will be screened for inclusion into the trial. Informed consent is obtained at least on the day before surgery and patients meeting the eligibility criteria will be enrolled into the study.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Baden-Württemberg
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Heidelberg、Baden-Württemberg、ドイツ、69120
- 募集
- Department of General, Visceral and Transplantation Surgery, University of Heidelberg
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コンタクト：
- Rahbari
- メール：nuh.rahbari@med.uni-heidelberg.de
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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:
- Pancreatic head cancer (diagnosis by clinical, laboratory and radiological evaluation)
- Patients scheduled for curative resection
- No evidence of distant metastases
- Age equal or greater than 18 years
- Informed consent
Exclusion Criteria:
- Expected lack of compliance
- Impaired mental state or language problems
- patient having had neoadjuvant radiochemotherapy
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：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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実験的：Artery first group
The basic principle of the "artery first" approach is the early identification of the SMA at its origin at the aorta with the further resection then being guided by its anatomic course. The dissection is carried cephalad along the aorta until the origin of the SMA is reached. The posterior and right aspect of the SMA is then dissected over a few centimeters. On the right side of the SMA a replaced or accessory right hepatic artery, if present, will be identified and preserved. This maneuver should be done, if infiltration of the SMA is suspected as the procedure can be terminated at this point. Once the situation at the SMA is assessed and resectability is confirmed resection will be done. |
early identification of SMA to evaluate infiltration
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アクティブコンパレータ：Conventional Group
A wide Kocher manoeuver is performed to fully mobilize the duodenum and the head of the pancreas.
The colonic mesentery on the right side is separated from the anterior surface of the duodenum and the head of the pancreas.
The size of the tumor and its relation to the superior mesenteric artery, the celiac trunk, the mesentery, the portal vein, and the superior mesenteric vein is assessed.
If resectability is given a Kausch-Whipple's resection is performed.
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conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma
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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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Rate of R1 resections
時間枠：up to 1.5 years
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positive resection margins as described by the pathologists of the University of Heidelberg
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up to 1.5 years
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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 |
|---|---|---|
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Exploratory analyses
時間枠：up to 1.5 years
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Exploratory analyses of frequencies of complications and serious adverse events
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up to 1.5 years
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協力者と研究者
スポンサー
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 (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。