NSCLC に対するロボット支援とビデオ支援による肺葉切除術 (RAVAR) (RAVAR)
非小細胞肺がんに対するロボット支援対ビデオ支援による肺葉切除術（RAVAR）：多施設共同、非盲検、無作為化、非劣性試験
Video-assisted thoracic surgery (VATS) has been recommended by clinical guidelines as one of the preferred surgeries for early-stage non-small cell lung cancer (NSCLC) for many years. However, VATS has inherent drawbacks, so at the beginning of this century, robotic-assisted thoracoscopic surgery (RATS) was first applied for lung resection. In recent years, RATS has developed rapidly, but there are still many unsolved scientific problems in the field of RATS. Thus, a multicenter prospective randomized controlled trial was conducted with stage I-II NSCLC patients as the study subject and 5-year DFS as the primary endpoint to compare the short-term and long-term outcomes of RATS and VATS in the treatment of early-stage NSCLC.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Chongqing Municipality
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Chongqing、Chongqing Municipality、中国、400014
- First Affiliated Hospital of Chongqing Medical University
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Gansu
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Lanzhou、Gansu、中国、730030
- The Second Hospital of Lanzhou University
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Lanzhou、Gansu、中国、730000
- Gansu Provincial Hospital
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Guangdong
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Guangzhou、Guangdong、中国、510060
- Sun Yat-sen University Cancer Center
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Guangzhou、Guangdong、中国、510080
- Guangdong Provincial People's Hospital
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Shenzhen、Guangdong、中国、518020
- Shenzhen People's Hospital
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Shenzhen、Guangdong、中国、518112
- Shenzhen Third People's Hospital
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Guangxi
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Guilin、Guangxi、中国、541002
- Guangxi Nanxishan Hospital
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Henan
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Zhengzhou、Henan、中国、450052
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan、Hubei、中国、430022
- Wuhan Union Hospital
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Wuhan、Hubei、中国、430030
- Wuhan TongJi Hospital
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Jiangsu
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Nanjing、Jiangsu、中国、210009
- Jiangsu Cancer Institute & Hospital
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Nanjing、Jiangsu、中国、210002
- The General Hospital of Eastern Theater Command
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Jiangxi
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Nanchang、Jiangxi、中国、330006
- The First Affiliated Hospital of Nanchang University
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Nanchang、Jiangxi、中国、330006
- Jiangxi Provincial People's Hopital
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Liaoning
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Shenyang、Liaoning、中国、110042
- Liaoning Tumor Hospital & Institute
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Shaanxi
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Xi'an、Shaanxi、中国、710038
- Tang-Du Hospital
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Shandong
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Jinan、Shandong、中国、250012
- Qilu Hospital of Shandong University
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Jinan、Shandong、中国、250014
- Qianfoshan Hospital
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Jinan、Shandong、中国、250022
- Shandong Provincial Hospital
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Qingdao、Shandong、中国、266003
- The Affiliated Hospital of Qingdao University
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Sichuan
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Chengdu、Sichuan、中国、610041
- West China Hospital
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Chengdu、Sichuan、中国、610041
- Sichuan Cancer Hospital and Research Institute
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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:
- Age from 18 to 80 years old;
- Patients with blood pressure<160/100mmHg, 5.6<blood glucose<11.2mmol/L, major organs function normally: (1) Goldman index between grade 1 and 2; (2) Predicted forced expiratory volume in 1s (FEV1) >= 40 % and diffusing capacity of the lung for carbon monoxide (DLCO) >= 40 %; (3) total bilirubin <= 1.5 upper limit of normal; (4) Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) <= 2.5 upper limit of normal; (5) creatinine <= 1.25 upper limit of normal and creatinine clearance rate (CCr) >= 60ml/min;
- The first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types;
- Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor <= 5cm and short diameter of mediastinal lymph node <= 1cm in thin layer CT;
- Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1;
- All relevant examinations were completed within 28 days before the operation;
- Patients who understand this study and have signed an approved Informed Consent.
Exclusion Criteria:
- Patients with radiotherapy, chemotherapy, targeted therapy, or immunotherapy before surgery.
- Patients with the previous history of other malignancies;
- Patients with secondary primary cancer when enrolled;
- Patients diagnosed as pure ground glass opacity (GGO) before surgery;
- Patients diagnosed as mixed GGO whose solid part <= 50% and Maximum diameter of tumor <= 2cm;
- Patients with small cell lung cancer;
- Patients with prior unilateral open thoracic surgical procedures;
- Woman who is pregnant or breastfeeding;
- Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
- Patients with an active bacterial or fungal infection that is difficult to control;
- Patients with serious psychosis;
- Patients with a history of severe heart attack, heart failure, myocardial infarction, or angina within the last 6 months.
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：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 |
|---|---|
|
実験的：RATS group
Patients will receive robot-assisted lobectomy |
Patients will receive robot-assisted lobectomy using Da Vinci surgical system |
|
アクティブコンパレータ：VATS group
Patients will receive video-assisted lobectomy |
Patients will receive video-assisted lobectomy |
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 |
|---|---|---|
|
5-year disease-free survival (DFS)
時間枠：5 years after surgery
|
Difference of 5-year disease free survival rate between the two groups |
5 years after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
5-year overall survival (OS)
時間枠：5 years after surgery
|
Difference of 5-year overall survival rate between the two groups |
5 years after surgery
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3-year disease-free survival (DFS)
時間枠：3 years after surgery
|
Difference of 3-year disease free survival rate between the two groups |
3 years after surgery
|
|
3-year overall survival (OS)
時間枠：3 years after surgery
|
Difference of 3-year overall survival rate between the two groups |
3 years after surgery
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Blood loss
時間枠：During the surgery
|
Blood loss during the surgery |
During the surgery
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Conversion rate
時間枠：During the surgery
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The number of patients converted to thoracotomy divided by the total number of included patients in a group |
During the surgery
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Perioperative complication
時間枠：The day of surgery, 2/4/8/12/26/52 weeks after surgery
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Intraoperative and postoperative complications |
The day of surgery, 2/4/8/12/26/52 weeks after surgery
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Operative death rate
時間枠：30/90 days after surgery
|
The number of patients died within 30/90 days after surgery divided by the total number of included patients in a group |
30/90 days after surgery
|
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Hospital stays after surgery
時間枠：Between the date of surgery and the date of discharge, assessed up to 30 days
|
The length of stay in hospital after surgery |
Between the date of surgery and the date of discharge, assessed up to 30 days
|
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Pain score after surgery
時間枠：Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge
|
The degree of pain after surgery was measured using Numerical Rating Scale (NRS). The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable). The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours. |
Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge
|
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R0 rate
時間枠：Postoperative in-hospital stay up to 30 days
|
The number of patients received R0 surgery divided by the total number of included patients in a group |
Postoperative in-hospital stay up to 30 days
|
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Operative time
時間枠：During the surgery
|
The total time from skin to skin and the time of each step were recorded |
During the surgery
|
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The number of resected lymph nodes
時間枠：Postoperative in-hospital stay up to 30 days
|
The number of resected lymph nodes were calculated according to the official pathological report after surgery |
Postoperative in-hospital stay up to 30 days
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Chest tube duration
時間枠：Postoperative in-hospital stay up to 30 days
|
The number of days between the date of surgery and the date of chest tube removal |
Postoperative in-hospital stay up to 30 days
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Acesodyne (Grade III) dose
時間枠：Postoperative in-hospital stay up to 30 days
|
The total amount of morphine used by the patient during the postoperative hospital stay, including morphine, pethidine, and fentanyl etc. |
Postoperative in-hospital stay up to 30 days
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Total cost of hospitalization
時間枠：From the date of admission to the date of discharge, assessed up to 30 days
|
The total cost of the patient from admission to discharge |
From the date of admission to the date of discharge, assessed up to 30 days
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Hao-Xian Yang, M.D.、Sun Yat-Sen University Cancer 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 (実際)
一次修了 (推定)
研究の完了 (推定)
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
その他の研究ID番号
- SL-5010-2019-04
- ChiCTR2000034737 (レジストリ識別子：Chinese Clinical Trial Registry)
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?
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
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