Survival benefit of bursectomy in patients with resectable gastric cancer: interim analysis results of a randomized controlled trial

Abstract

Background 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. Methods 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. Results 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 nonbursectomy group had peritoneal recurrences than in the bursectomy group (13.2 vs. 8.7%). Conclusions 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.

Improving the outcomes in gastric cancer surgery

“…Several studies did not show a benefit of bursectomy [77,78] . But proponents of this technique argue that it may improve survival and should not be discarded as a futile technique [79] . A phase Ⅲ trial is currently ongoing in Japan that will also evaluate the effectiveness of procedure (see: http://www.jcog.jp/en/trials/index.…”

Surgical skills for laparoscopic resection of the bursa omentalis and lymph node scavenging with radical gastrectomy

“…Although, due to the lack of concrete proof, disputes remain over whether patients can benefit from bursa omentalis resection clinically, the mid-term evaluation of a prospective, random and multi-center clinical study (3) in Japan showed that bursa omentalis resection may aid in increasing the post-operative survival rate of patients with gastric carcinoma. Therefore, unless more definite proof is obtained, the use of bursa omentalis resection will not be stopped.…”

“…However, the Japanese Classification of Gastric Carcinoma (14th edition) (4) clearly indicates that, for cases in which the serosa of the posterior gastric wall has been invaded by the tumor, a bursa omentalis resection should be performed for the purpose of cleaning up the tiny planting nidi in the bursa omentalis (3). In traditional open surgery, the difficulty of a bursa omentalis resection is low, but in laparoscopic resection of gastric carcinoma with radical gastrectomy, it has become one of the difficult points in the surgery (5,6).…”

Current status and future perspectives of laparoscopic radical surgery for advanced gastric cancer

“…Furthermore, historically, bursectomy, which removes the whole sac of the bursa omentalis, including the anterior leaf of transverse colon mesentery as well as the anterior capsule of pancreas body for prophylactic local control in addition to total omentectomy, had been performed by some experienced surgeons in Japan (2). The theoretical rationale for bursectomy is to reduce the risk of peritoneal recurrences by removing the peritoneum which might contain micrometastases.…”