Motohiro Hirao1, Yukinori Kurokawa2, Junya Fujita3, Hiroshi Imamura4, Yoshiyuki Fujiwara5, Yutaka Kimura6, Shuji Takiguchi7, Masaki Mori7, Yuichiro Doki7. 1. Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan. 2. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan. Electronic address: ykurokawa@gesurg.med.osaka-u.ac.jp. 3. Department of Surgery, NTT West Osaka Hospital, Osaka, Japan. 4. Department of Surgery, Toyonaka Municipal Hospital, Osaka, Japan. 5. Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. 6. Department of Surgery, Sakai Municipal Hospital, Osaka, Japan. 7. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Abstract
BACKGROUND: Bursectomy, a traditional operative procedure to remove the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon, has been performed for serosa-positive gastric cancer in Japan and Eastern Asia. We conducted a multicenter, randomized, controlled trial to demonstrate the noninferiority of the omission of bursectomy. METHODS:Between July 2002 and January 2007, 210 patients with cT2-3 gastric adenocarcinoma were randomized intraoperatively to D2 gastrectomy with or without bursectomy. The primary endpoint was overall survival (OS). We provide the results of the final analysis of the complete 5-year follow-up data. RESULTS: After the median follow-up of 80 months, 5-year OS was 77.5% for the bursectomy group and 71.3% for the nonbursectomy group (2-sided P = .16 for superiority; 1-sided P = .99 for noninferiority). The hazard ratio for death in the nonbursectomy group was 1.40 (95% CI, 0.87-2.25). The 5-year recurrence-free survivals were 73.7% and 66.6% in the bursectomy and nonbursectomy groups, respectively (2-sided P = .33 for superiority; 1-sided P = .99 for noninferiority). Cox multivariate analysis revealed that bursectomy was an independent prognostic factor of good OS (P = .033). Subgroup analysis showed a trend toward improved survival after bursectomy for tumors in the middle or lower third of the stomach and for pathologically serosa-positive tumors. CONCLUSION: The final analysis could not demonstrate the noninferiority of the omission of bursectomy. Bursectomy should not be abandoned as a futile procedure.
RCT Entities:
BACKGROUND: Bursectomy, a traditional operative procedure to remove the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon, has been performed for serosa-positive gastric cancer in Japan and Eastern Asia. We conducted a multicenter, randomized, controlled trial to demonstrate the noninferiority of the omission of bursectomy. METHODS: Between July 2002 and January 2007, 210 patients with cT2-3 gastric adenocarcinoma were randomized intraoperatively to D2 gastrectomy with or without bursectomy. The primary endpoint was overall survival (OS). We provide the results of the final analysis of the complete 5-year follow-up data. RESULTS: After the median follow-up of 80 months, 5-year OS was 77.5% for the bursectomy group and 71.3% for the nonbursectomy group (2-sided P = .16 for superiority; 1-sided P = .99 for noninferiority). The hazard ratio for death in the nonbursectomy group was 1.40 (95% CI, 0.87-2.25). The 5-year recurrence-free survivals were 73.7% and 66.6% in the bursectomy and nonbursectomy groups, respectively (2-sided P = .33 for superiority; 1-sided P = .99 for noninferiority). Cox multivariate analysis revealed that bursectomy was an independent prognostic factor of good OS (P = .033). Subgroup analysis showed a trend toward improved survival after bursectomy for tumors in the middle or lower third of the stomach and for pathologically serosa-positive tumors. CONCLUSION: The final analysis could not demonstrate the noninferiority of the omission of bursectomy. Bursectomy should not be abandoned as a futile procedure.
Authors: Hylke J F Brenkman; Nicole I van der Wielen; Jelle P Ruurda; Maarten S van Leeuwen; Joris J G Scheepers; Donald L van der Peet; Richard van Hillegersberg; Ronald L A W Bleys; Miguel A Cuesta Journal: J Thorac Dis Date: 2017-07 Impact factor: 2.895
Authors: Giovanni De Manzoni; Daniele Marrelli; Gian Luca Baiocchi; Paolo Morgagni; Luca Saragoni; Maurizio Degiuli; Annibale Donini; Uberto Fumagalli; Maria Antonietta Mazzei; Fabio Pacelli; Anna Tomezzoli; Mattia Berselli; Filippo Catalano; Alberto Di Leo; Massimo Framarini; Simone Giacopuzzi; Luigina Graziosi; Alberto Marchet; Mario Marini; Carlo Milandri; Gianni Mura; Elena Orsenigo; Vittorio Quagliuolo; Stefano Rausei; Riccardo Ricci; Fausto Rosa; Giandomenico Roviello; Andrea Sansonetti; Giovanni Sgroi; Guido Alberto Massimo Tiberio; Giuseppe Verlato; Carla Vindigni; Riccardo Rosati; Franco Roviello Journal: Gastric Cancer Date: 2016-06-02 Impact factor: 7.370