Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan.
Gastric Cancer. 2012 Jan;15(1):42-8. doi: 10.1007/s10120-011-0058-9. Epub 2011 May 15.
Bursectomy is regarded as a standard surgical procedure during gastrectomy for serosa-positive gastric cancer in Japan. There is little evidence, however, that bursectomy has clinical benefit. We conducted a randomized controlled trial to demonstrate non-inferiority of treatment with the omission of bursectomy.
Between July 2002 and January 2007, 210 patients with cT2-T3 gastric adenocarcinoma were intraoperatively randomized to radical gastrectomy and D2 lymphadenectomy with or without bursectomy. The primary endpoint was overall survival (OS). Secondary endpoints were recurrence-free survival, operative morbidity, and levels of amylase in drainage fluid on postoperative day 1. Two interim analyses were performed, in September 2008 and August 2010.
Overall morbidity (14.3%) and mortality (0.95%) rates were the same in the two groups. The median levels of amylase in drainage fluid on postoperative day 1 were similar in the two groups (P = 0.543). In the second interim analysis, the 3-year OS rates were 85.6% in the bursectomy group and 79.6% in the non-bursectomy group. The hazard ratio for death without bursectomy was 1.44 (95% confidence interval [CI] 0.79-2.61; P = 0.443 for non-inferiority). Among 48 serosa-positive (pT3-T4) patients, the 3-year OS was 69.8% for the bursectomy group and 50.2% for the non-bursectomy group, conferring a hazard ratio for death of 2.16 (95% CI 0.89-5.22; P = 0.791 for non-inferiority). More patients in the non-bursectomy group had peritoneal recurrences than in the bursectomy group (13.2 vs. 8.7%).
The interim analyses suggest that bursectomy may improve survival and should not be abandoned as a futile procedure until more definitive data can be obtained.
在日本，对于浆膜阳性的胃癌患者，行胃切除术时进行囊切除术被认为是一种标准的手术程序。然而，几乎没有证据表明囊切除术具有临床益处。我们进行了一项随机对照试验，以证明在不切除囊的情况下进行治疗不劣于前者。
2002 年 7 月至 2007 年 1 月，210 名 cT2-T3 胃腺癌患者在术中被随机分为根治性胃切除术和 D2 淋巴结清扫术，加或不加囊切除术。主要终点是总生存期（OS）。次要终点是无复发生存期、手术发病率和术后第 1 天引流液中淀粉酶的水平。在 2008 年 9 月和 2010 年 8 月进行了两次中期分析。
两组的总发病率（14.3%）和死亡率（0.95%）相同。两组术后第 1 天引流液中淀粉酶的中位数水平相似（P=0.543）。在第二次中期分析中，囊切除术组的 3 年 OS 率为 85.6%，非囊切除术组为 79.6%。无囊切除术死亡的风险比为 1.44（95%置信区间[CI]0.79-2.61；P=0.443 用于非劣效性）。在 48 例浆膜阳性（pT3-T4）患者中，囊切除术组的 3 年 OS 率为 69.8%，非囊切除术组为 50.2%，死亡风险比为 2.16（95%CI0.89-5.22；P=0.791 用于非劣效性）。非囊切除术组比囊切除术组有更多的腹膜复发（13.2 例 vs. 8.7 例）。
中期分析表明，囊切除术可能提高生存率，在获得更明确的数据之前，不应将其视为无效程序而放弃。
