Randomized controlled trial to evaluate splenectomy in total gastrectomy for proximal gastric carcinoma (JCOG0110): Analyzes of operative morbidity, operation time, and blood loss.

Abstract

4020 Background: In European gastrectomy trials, splenectomy was an important risk factor for operative morbidity/mortality associated with poor long-term survival. In Japan where splenectomy seldom causes mortality, 20-30% of proximal gastric carcinomas have nodal metastasis in the splenic hilum and its complete removal with splenectomy produces a cure in about 20% of them. Methods: We conducted a randomized controlled trial to compare splenectomy and spleen preservation in total gastrectomy. Proximal gastric adenocarcinoma of T2-4/N0-2/M0 not involving the greater curvature was eligible. During operation surgeons confirmed that R0 resection was possible with negative lavage cytology, and randomized the patient into splenectomy (pancreas-preserving total gastrectomy, D2) or spleen-preserving group (total gastrectomy, D2, no pancreatic mobilization). The primary endpoint is overall survival, and the secondary endpoints are operative morbidity, operation time and blood loss. The trial was designed to evaluate noninferiority of spleen preservation to splenectomy in overall survival. Sample size was determined to be 500 with one-sided alpha of 0.05 and a noninferiority margin of the hazard ratio as 1.21. The final survival analysis is scheduled for 2014. Results: Between June 2002 and March 2009, 505 patients (splenectomy 254, spleen-preservation 251) were enrolled from 36 institutions. Operative mortality was seen in 3 patients (0.6%: splenectomy 1; spleen-preservation 2). Operative morbidity was significantly higher in splenectomy group (30.3%) than in spleen-preserving group (16.7%) (p < 0.001). Blood loss was significantly larger in splenectomy group (median 390.5 mL vs. 315 mL, p = 0.02), but there was no difference in operation time (median 231 vs. 224 min). Five more lymph nodes (median 64 vs. 59) were dissected in splenectomy group. Conclusions: Splenectomy in total gastrectomy was associated with higher morbidity and larger blood loss but not longer operation time than spleen preservation, and was safely performed by specialized surgeons with low mortality. The impact on long term survival should be awaited. No significant financial relationships to disclose.