评估近端胃癌全胃切除术中脾切除术的随机对照试验

Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma.

作者信息

Sano Takeshi, Sasako Mitsuru, Mizusawa Junki, Yamamoto Seiichiro, Katai Hitoshi, Yoshikawa Takaki, Nashimoto Atsushi, Ito Seiji, Kaji Masahide, Imamura Hiroshi, Fukushima Norimasa, Fujitani Kazumasa

机构信息

*Department of Surgery, Cancer Institute Hospital, Tokyo, Japan †Department of Surgery, Hyogo College of Medicine, Hyogo, Japan ‡Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo, Japan §Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan ¶Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan ||Department of Surgery, Niigata Cancer Center Hospital, Niigata, Japan **Department of Gastroenterological Surgery, Aichi Cancer Center, Nagoya, Japan ††Department of Surgery, Toyama Prefectural Central Hospital, Toyama City, Japan ‡‡Department of Surgery, Sakai City Medical Center, Sakai, Japan §§Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan ¶¶Department of Surgery, Osaka National Hospital, Osaka, Japan.

出版信息

Ann Surg. 2017 Feb;265(2):277-283. doi: 10.1097/SLA.0000000000001814.

DOI:10.1097/SLA.0000000000001814

PMID:27280511

Abstract

OBJECTIVE

To clarify the role of splenectomy in total gastrectomy for proximal gastric cancer.

BACKGROUNDS

Splenectomy in total gastrectomy is associated with increased operative morbidity and mortality, but its survival benefit is unclear. Previous randomized controlled trials were underpowered and inconclusive.

METHODS

We conducted a multiinstitutional randomized controlled trial. Proximal gastric adenocarcinoma of T2-4/N0-2/M0 not invading the greater curvature was eligible. During the operation, surgeons confirmed that R0 resection was possible with negative lavage cytology, and patients were randomly assigned to either splenectomy or spleen preservation. The primary endpoint was overall survival (OS) and the secondary endpoints were relapse-free survival, operative morbidity, operation time, and blood loss. The trial was designed to confirm noninferiority of spleen preservation to splenectomy in OS with a noninferiority margin of the hazard ratio as 1.21 and 1-sided alpha of 5%.

RESULTS

Between June 2002 and March 2009, 505 patients (254 splenectomy, 251 spleen preservation) were enrolled from 36 institutions. Splenectomy was associated with higher morbidity and larger blood loss, but the operation time was similar. The 5-year survivals were 75.1% and 76.4% in the splenectomy and spleen preservation groups, respectively. The hazard ratio was 0.88 (90.7%, confidence interval 0.67-1.16) (<1.21); thus, the noninferiority of spleen preservation was confirmed (P = 0.025).

CONCLUSIONS

In total gastrectomy for proximal gastric cancer that does not invade the greater curvature, splenectomy should be avoided as it increases operative morbidity without improving survival.

摘要

目的

阐明脾切除术在近端胃癌全胃切除术中的作用。

背景

全胃切除术中的脾切除术与手术发病率和死亡率增加相关，但其生存获益尚不清楚。既往随机对照试验的样本量不足且结论不明确。

方法

我们开展了一项多机构随机对照试验。纳入T2-4/N0-2/M0期未侵犯大弯侧的近端胃腺癌患者。手术过程中，外科医生确认可行R0切除且灌洗细胞学检查阴性，患者被随机分配至脾切除组或保脾组。主要终点为总生存期（OS），次要终点为无复发生存期、手术发病率、手术时间和失血量。该试验旨在证实保脾组在OS方面不劣于脾切除组，非劣效界值为风险比1.21，单侧α为5%。

结果

2002年6月至2009年3月期间，来自36家机构的505例患者（254例行脾切除术，251例行保脾术）入组。脾切除术与更高的发病率和更多的失血量相关，但手术时间相似。脾切除组和保脾组的5年生存率分别为75.1%和76.4%。风险比为0.88（90.7%，置信区间0.67-1.16）（<1.）；因此，证实了保脾的非劣效性（P = 0.025）。