Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for AGC
Study on Short and Long-term Outcome of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer
調査の概要
詳細な説明
Radical resection is the primary treatment for patients with advanced middle or upper third gastric cancer. And D2 lymphadenectomy, including No. 10 lymph node dissection, should be performed according to the Japanese treatment guidelines for gastric cancer. Because of the complexity of the anatomy around the spleen, spleen-preserving No. 10 lymph node dissection is difficult. Although Professor Huang from Fujian Medical University Union Hospital has proposed the "Huang's three-step maneuver" to dissect No. 10 lymph node with preserved spleen laparoscopically, such method is far from popularized, especially in North China. In addition, the safety, feasibility and oncological efficacy of this method was not confirmed in such area, either.
In this study, a prospective, single center, single-arm, non-inferiority clinical trial will be conducted to evaluate the short and long-term outcome of the laparoscopic spleen-preserving No. 10 lymph node dissection for patients with locally advanced middle or upper third gastric cancer in Beijing.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Zaozao Wang
- 電話番号:0086-10-88196851
- メール:zaozao83630@sina.com
研究場所
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Beijing
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Beijing、Beijing、中国、100142
- 募集
- Beijing Cancer Hospital
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コンタクト:
- Xiangqian Su
- 電話番号:0086-10-88196696
- メール:suqiangqian@bjmu.edu.cn
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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:
- Patients age older than 18 years (including 18 years old);
- The primary lesion is located in the upper or middle third of the stomach, including Siewert II type and Siewert III type adenocarcinoma of the esophagogastric junction;
- Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy (including papillary, tubular, mucinous, signet ring cell and poorly differentiated adenocarcinoma);
- Preoperative cancer stage cT2-4aN0-3M0 (according to AJCC-7th TNM staging);
- The Eastern Cooperative Oncology Group performance status of 0 or 1;
- The American Society of Anesthesiology classes of I, II or III;
- Signed Informed consent.
Exclusion Criteria:
- Pregnant or lactating women;
- Suffering from severe mental disorder;
- Previous gastrectomy, including endoscopic submucosal dissection and endoscopic mucosal resection;
- Integrated or enlarged lymph node with maximum diameter larger than 3 cm according to preoperative imaging, including significantly enlarged or bulky No. 10 lymph nodes;
- Siewert I type adenocarcinoma of the esophagogastric junction;
- Other malignant diseases (within 5 years);
- Other illnesses needed operation concurrently;
- Complications (bleeding, perforation or obstruction) required emergency surgery due to primary gastric malignancy;
- Pulmonary function tests FEV1 less than 50% of predicted value;
- Patient suffered from bleeding tendency disease such as hemophilia or took anti-coagulant medication due to deep vein thrombosis.
- Patients with obvious tumor infiltration in the spleen and splenic vessels which require splenectomy.
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:なし
- 介入モデル:単一グループの割り当て
- 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 |
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実験的:No. 10 Lymph Node Dissection group
Patients with locally advanced upper or middle third gastric cancer will receive laparoscopic total gastrectomy and D2 lymphadenectomy with spleen-preserving No.10 lymph node dissections
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For patients with locally advanced upper or middle third gastric cancer, laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-preserving No. 10 lymph node dissection is performed.
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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 |
時間枠 |
---|---|
the incidence of postoperative complications within 30 days
時間枠:30 days
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30 days
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二次結果の測定
結果測定 |
時間枠 |
---|---|
3-year disease free survival
時間枠:36 months
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36 months
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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
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。
腹腔鏡手術の臨床試験
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Dong Yangわからない腹腔鏡補助下手術 | 切開を行わない全腹腔鏡手術(Natural Orifice Transluminal Endoscopic Surgery、NOSES)中国