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首页> 外文期刊>Surgical Endoscopy >Long-term outcomes of laparoscopy-assisted distal gastrectomy for early gastric cancer: result of a randomized controlled trial (COACT 0301).
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Long-term outcomes of laparoscopy-assisted distal gastrectomy for early gastric cancer: result of a randomized controlled trial (COACT 0301).

机译:腹腔镜辅助远端胃切除术治疗早期胃癌的远期结果:一项随机对照试验的结果(COACT 0301)。

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The purpose of this study was to evaluate laparoscopy-assisted distal gastrectomy (LADG) compared to open distal gastrectomy (ODG) in the treatment of early gastric cancer with respect to survival, surgical outcomes, complications, and quality of life (QOL).One hundred sixty-four patients with cT1N0M0 and cT1N1M0 distal gastric cancer were randomly assigned to either the LADG group or the ODG group. The primary end point was the 5-year disease-free survival (DFS) rate. Complications were classified using the accordion severity classification of postoperative complications scheme. QOL was measured using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-STO22 preoperatively and postoperatively during regular follow-up visits. This trial is registered at ClinicalTrials.gov (NCT00546468).The median (range) follow-up period was 74.3 (24.8-90.8) months. The LADG and ODG groups showed similar survival [5-year DFS rate: 98.8 % vs. 97.6 %, respectively (P = 0.514), 5-year overall survival (OS) rate: 97.6 vs. 96.3 %, respectively (P = 0.721)] or overall complication rate (29.3 vs. 42.7 %, respectively; P = 0.073). Mild complications were significantly less frequent in the LADG group than in the ODG group (23.2 vs. 41.5 %; P = 0.012). The rates of moderate, severe, and long-term complications (i.e., 31 days to 5 years after surgery) did not differ significantly between groups. No clinically meaningful differences were detected between the two groups in long-term QOL.LADG showed similar DFS and OS compared to ODG in treating early gastric cancer. Marginal benefits in mild complications were observed with LADG. LADG did not show advantages over ODG regarding other complications and long-term QOL.
机译:这项研究的目的是评估腹腔镜辅助远端胃切除术(LADG)与开腹远端胃切除术(ODG)在早期胃癌治疗方面的生存率,手术结局,并发症和生活质量(QOL)。 164例cT1N0M0和cT1N1M0远端胃癌患者被随机分为LADG组或ODG组。主要终点是5年无病生存率(DFS)。使用术后并发症方案的手风琴严重性分类对并发症进行分类。使用欧洲癌症研究与治疗组织QLQ-C30和QLQ-STO22在定期随访期间进行术前和术后的QOL测量。该试验已在ClinicalTrials.gov(NCT00546468)上进行了注册。随访的中位时间为74.3(24.8-90.8)个月。 LADG和ODG组的生存率相似[5年DFS率分别为98.8%和97.6%(P = 0.514),5年总生存率(OS)分别为97.6和96.3%(P = 0.721) )]或总体并发症发生率(分别为29.3%和42.7%; P = 0.073)。 LADG组的轻度并发症发生率明显低于ODG组(23.2 vs. 41.5%; P = 0.012)。两组之间的中度,重度和长期并发症发生率(即手术后31天至5年)没有显着差异。在长期QOL中两组之间未发现具有临床意义的差异。在早期胃癌的治疗中,LADG与ODG相比具有相似的DFS和OS。 LADG可观察到轻度并发症的边缘获益。在其他并发症和长期QOL方面,LADG没有显示出比ODG更好的优势。

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