Prospective randomized controlled trial to compare laparoscopic distal gastrectomy (D2 lymphadenectomy plus complete mesogastrium excision, D2 + CME) with conventional D2 lymphadenectomy for locally advanced gastric adenocarcinoma: study protocol for a randomized controlled trial.
Prospective randomized controlled trial to compare laparoscopic distal gastrectomy (D2 lymphadenectomy plus complete mesogastrium excision, D2 + CME) with conventional D2 lymphadenectomy for locally advanced gastric adenocarcinoma: study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-018-2790-5
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发表时间：
2018-08-09
期刊：
影响因子：
2.5
通讯作者：
Gong J
中科院分区：
文献类型：
--
作者：
Shen J;Cao B;Wang Y;Xiao A;Qin J;Wu J;Yan Q;Hu Y;Yang C;Cao Z;Hu J;Yin P;Xie D;Gong J
胃癌根治术联合D2淋巴结清扫术虽已成为局部进展期胃癌的标准手术方式，但患者术后预后仍较差。先前，我们提出腹腔镜下远端胃切除术（D2淋巴结切除术+完全胃系膜切除术[D2 + CME]）作为局部晚期胃癌的优化手术方法。D2 + CME沿肠系膜边界清扫，完全切除背侧肠系膜近段，出血量少，改善了近期手术效果。然而，D2 + CME的肿瘤治疗效果尚未得到证实。我们在中国武汉同济医院对局部进展期胃癌患者进行了一项单中心、前瞻性、平行组、随机对照的腹腔镜下远端胃切除术D2 + CME与常规D2的对比研究。总共有336名符合以下合格标准的患者被纳入研究，并随机接受D2 + CME或D2手术：(1)病理证实的腺癌；（二）年满十八周岁至七十五周岁；术前评价cT2-4、N0-3、M0；(3)预期根治性腹腔镜胃远端切除术；(4)无其他肿瘤、化疗、放疗史；(5)无上腹部手术史；(6)围手术期美国麻醉医师学会I、II或III级。主要终点是3年无病生存期。次要终点是总生存、复发模式、死亡率、发病率、术后恢复过程和其他参数。既往研究证实D2 + CME治疗局部晚期胃癌的安全性和可行性；然而，仍缺乏证据支持其治疗效果。因此，我们进行了这项随机试验，以研究D2 + CME是否可以改善局部晚期胃癌患者的肿瘤预后。这项试验的发现可能会优化手术程序，并可能改善局部晚期胃癌患者的预后。ClinicalTrials.gov NCT01978444。2013年10月31日注册。本文的在线版本（10.1186/s13063-018-2790-5）包含补充资料，仅供授权用户使用。
Although radical gastrectomy with D2 lymph node dissection has become the standard surgical approach for locally advanced gastric cancer, patients still have a poor prognosis after operation. Previously, we proposed laparoscopic distal gastrectomy (D2 lymphadenectomy plus complete mesogastrium excision [D2 + CME]) as an optimized surgical procedure for locally advanced gastric cancer. By dissection along the boundary of the mesogastrium, D2 + CME resected proximal segments of the dorsal mesogastrium completely with less blood loss, and it improved the short-term surgical outcome. However, the oncologic therapeutic effect of D2 + CME has not yet been confirmed. A single-center, prospective, parallel-group, randomized controlled trial of laparoscopic distal gastrectomy with D2 + CME versus conventional D2 was conducted for patients with locally advanced gastric cancer at Tongji Hospital, Wuhan, China. In total, 336 patients who met the following eligibly criteria were included and were randomized to receive either the D2 + CME or D2 procedure: (1) pathologically proven adenocarcinoma; (2) 18 to 75 years old; cT2–4, N0–3, M0 at preoperative evaluation; (3) expected curative resection via laparoscopic distal gastrectomy; (4) no history of other cancer, chemotherapy, or radiotherapy; (5) no history of upper abdominal operation; and (6) perioperative American Society of Anesthesiologists class I, II, or III. The primary endpoint is 3 years of disease-free survival. The secondary endpoints are overall survival, recurrence pattern, mortality, morbidity, postoperative recovery course, and other parameters. Previous studies have demonstrated the safety and feasibility of D2 + CME for locally advanced gastric cancer; however, there is still a lack of evidence to support its therapeutic effect. Thus, we performed this randomized trial to investigate whether D2 + CME can improve oncologic outcomes of patients with locally advanced gastric cancer. The findings from this trial may potentially optimize the surgical procedure and may improve the prognosis of patients with locally advanced gastric cancer. ClinicalTrials.gov, NCT01978444. Registered on October 31, 2013. The online version of this article (10.1186/s13063-018-2790-5) contains supplementary material, which is available to authorized users.
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影响因子：
4.7
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Xie, Daxing;Osaiweran, Hasan;Gong, Jianping
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