Long-term outcomes after prophylactic bursectomy in patients with resectable gastric cancer: Final analysis of a multicenter randomized controlled trial

Osaka University Clinical Research Group for Gastroenterological Study

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Article number4050
Pages (from-to)1099-1105
Number of pages7
JournalSurgery (United States)
Volume157
Issue number6
DOIs
Publication statusPublished - Jun 1 2015

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Stomach Neoplasms
Randomized Controlled Trials
Survival
Serous Membrane
Stomach
Mesocolon
Far East
Operative Surgical Procedures
Gastrectomy
Pancreas
Neoplasms
Japan
Adenocarcinoma
Multivariate Analysis
Recurrence

All Science Journal Classification (ASJC) codes

  • Surgery

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Long-term outcomes after prophylactic bursectomy in patients with resectable gastric cancer : Final analysis of a multicenter randomized controlled trial. / Osaka University Clinical Research Group for Gastroenterological Study.

In: Surgery (United States), Vol. 157, No. 6, 4050, 01.06.2015, p. 1099-1105.

Research output: Contribution to journalArticle

Osaka University Clinical Research Group for Gastroenterological Study. / Long-term outcomes after prophylactic bursectomy in patients with resectable gastric cancer : Final analysis of a multicenter randomized controlled trial. In: Surgery (United States). 2015 ; Vol. 157, No. 6. pp. 1099-1105.
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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.",
author = "{Osaka University Clinical Research Group for Gastroenterological Study} and Motohiro Hirao and Yukinori Kurokawa and Junya Fujita and Hiroshi Imamura and Yoshiyuki Fujiwara and Yutaka Kimura and Shuji Takiguchi and Masaki Mori and Yuichiro Doki",
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T1 - Long-term outcomes after prophylactic bursectomy in patients with resectable gastric cancer

T2 - Final analysis of a multicenter randomized controlled trial

AU - Osaka University Clinical Research Group for Gastroenterological Study

AU - Hirao, Motohiro

AU - Kurokawa, Yukinori

AU - Fujita, Junya

AU - Imamura, Hiroshi

AU - Fujiwara, Yoshiyuki

AU - Kimura, Yutaka

AU - Takiguchi, Shuji

AU - Mori, Masaki

AU - Doki, Yuichiro

PY - 2015/6/1

Y1 - 2015/6/1

N2 - 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.

AB - 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.

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