Robot-assisted IVOR-LEWIS Esophagectomy
キーワード
概要
説明
This confirmatory, nonrandomized, single-arm trial (phase II) will be conducted to evaluate short-and long-term outcomes of robot-assisted thoraco- laparoscopic minimally invasive esophagectomy for esophageal cancer. Patients will registered preoperatively. The planned sample size was 51. Preoperative endoscopic biopsy was performed in all patients to confirm the histological diagnosis of esophageal cancer. Staging workup included thorough history and physical examination, esophagogastroduodenoscopy, endoscopic ultrasonography, and integrated positron emission tomography/computed tomography scan. Patients with histologically proven malignancy were candidates for surgical procedures. Operability criteria were defined according to the National Comprehensive Cancer Network guidelines. All patients were within the American Society of Anesthesiologists (ASA) class I to III. In general, neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease. The primary endpoint in the first stage is the short-term postoperative complications, and that in the second stage is overall survival; patients continue to be followed up for this endpoint.
日付
最終確認済み: | 06/30/2019 |
最初に提出された: | 05/01/2017 |
提出された推定登録数: | 05/01/2017 |
最初の投稿: | 05/03/2017 |
最終更新が送信されました: | 07/10/2019 |
最終更新日: | 07/11/2019 |
実際の研究開始日: | 06/13/2017 |
一次完了予定日: | 07/09/2019 |
研究完了予定日: | 04/03/2024 |
状態または病気
段階
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | All |
サンプリング方法 | Probability Sample |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: 1. Patients with histologically proven esophageal malignancy 2. All patients were within the American Society of Anesthesiologists (ASA) class I to III 3. neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease Exclusion Criteria: Cancer located at the cervical esophageal Cancer located at the gastroesophageal junction history of surgery in the right thorax |
結果
主な結果の測定
1. short-term postoperative complications [30 days after surgery]
2. long-term overall survival [five years after surgery]
二次的な結果の測定
1. perioperative outcomes except for postoperative complications [30 days after surgery]