title: 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 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.
authors.affiliation: Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan.
authors.forename: Junya
authors.initials: J
authors.lastname: Fujita
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Kurokawa
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Sugimoto
authors.forename: Isao
authors.initials: I
authors.lastname: Miyashiro
authors.forename: Shohei
authors.initials: S
authors.lastname: Iijima
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kimura
authors.forename: Shuji
authors.initials: S
authors.lastname: Takiguchi
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Fujiwara
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D018572:Disease-Free Survival; D005260:Female; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D007564:Japan; D008197:Lymph Node Excision / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010529:Peritoneal Cavity / Q000473:pathology / Q000601:surgery; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D015996:Survival Rate