Published in:
01-01-2012 | Original article
Survival benefit of bursectomy in patients with resectable gastric cancer: interim analysis results of a randomized controlled trial
Published in: Gastric Cancer | Issue 1/2012
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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 non-bursectomy 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.