Fujitani K, Ando M, Sakamaki K, Terashima M, Kawabata R, Ito Y, Yoshikawa T, Kondo M, Kodera Y, Yoshida K
Department of Surgery Osaka Prefectural General Medical Centre Osaka Japan.
Centre for Advanced Medicine and Clinical Research Nagoya University Hospital Nagoya Japan.
BJS Open. 2018 Mar 15;1(6):165-174. doi: 10.1002/bjs5.26. eCollection 2017 Dec.
Quality of life (QoL) is a key component in decision-making for surgical palliation, but QoL data in association with surgical palliation in advanced gastric cancer are scarce. The aim of this multicentre observational study was to examine the impact of surgical palliation on QoL in advanced gastric cancer.
The study included patients with gastric outlet obstruction caused by incurable advanced primary gastric cancer who had no oral intake or liquid intake only. Patients underwent palliative distal/total gastrectomy or bypass surgery at the physician's discretion. The primary endpoint was change in QoL assessed at baseline, 14 days, 1 month and 3 months following surgical palliation by means of the EuroQoL Five Dimensions (EQ-5D™) questionnaire and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire gastric cancer module (QLQ-STO22). Secondary endpoints were postoperative improvement in oral intake and surgical complications.
Some 104 patients (23 distal gastrectomy, 9 total gastrectomy, 70 gastrojejunostomy, 2 exploratory laparotomy) were enrolled from 35 institutions. The mean EQ-5D™ utility index scores remained consistent, with a baseline score of 0·74 and the change from baseline within ± 0·05. Gastric-specific symptoms showed statistically significant improvement from baseline. The majority of patients were able to eat solid food 2 weeks after surgery and tolerated it thereafter. The rate of overall morbidity of grade III or more according to the Clavien-Dindo classification was 9·6 per cent (10 patients) and the 30-day postoperative mortality rate was 1·9 per cent (2 patients).
In patients with gastric outlet obstruction caused by advanced gastric cancer, surgical palliation maintained QoL while improving solid food intake, with acceptable morbidity for at least the first 3 months after surgery. Registration number 000023494 (UMIN Clinical Trials Registry).
生活质量(QoL)是手术姑息治疗决策中的关键因素,但晚期胃癌手术姑息治疗相关的生活质量数据稀缺。这项多中心观察性研究的目的是探讨手术姑息治疗对晚期胃癌患者生活质量的影响。
该研究纳入了因无法治愈的晚期原发性胃癌导致胃出口梗阻、仅无经口摄入或仅液体摄入的患者。患者由医生酌情进行姑息性远端/全胃切除术或旁路手术。主要终点是通过欧洲五维健康量表(EQ-5D™)问卷和欧洲癌症研究与治疗组织生活质量问卷胃癌模块(QLQ-STO22)在手术姑息治疗后基线、14天、1个月和3个月时评估的生活质量变化。次要终点是术后经口摄入量的改善和手术并发症。
从35家机构招募了约104例患者(23例行远端胃切除术,9例行全胃切除术,70例行胃空肠吻合术,2例行剖腹探查术)。EQ-5D™效用指数平均得分保持一致,基线得分为0.74,与基线相比变化在±0.05以内。胃部特异性症状与基线相比有统计学意义的改善。大多数患者术后2周能够进食固体食物,并在此后耐受。根据Clavien-Dindo分类法,III级及以上的总体发病率为9.6%(10例患者),术后30天死亡率为1.9%(2例患者)。
在晚期胃癌导致胃出口梗阻的患者中,手术姑息治疗在改善固体食物摄入量的同时维持了生活质量,术后至少前3个月的发病率可接受。注册号000023494(UMIN临床试验注册中心)。