Department of Surgery, University of Nebraska Medical Center, Omaha.
Department of Biostatistics, University of Nebraska Medical Center, Omaha.
JAMA Netw Open. 2019 Jan 4;2(1):e186847. doi: 10.1001/jamanetworkopen.2018.6847.
Currently, rates of referral of patients with peritoneal metastasis in the United States who qualify for cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) are low, in part because of the misperception of high morbidity and mortality rates. However, patients requiring major gastrointestinal surgical procedures with similar complication rates are routinely referred.
To evaluate the relative safety of CRS/HIPEC.
DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of 34 114 patients who underwent CRS/HIPEC, right lobe hepatectomy, trisegmental hepatectomy, pancreaticoduodenectomy, and esophagectomy between January 1, 2005, and December 31, 2015, included in the American College of Surgeons National Surgical Quality Improvement Project (NSQIP) database. Data analysis was performed in 2018.
Data from the NSQIP database were used to compare perioperative and 30-day postoperative morbidity and mortality rates of CRS/HIPEC (1822 patients) with other, well-accepted, high-risk surgical oncology procedures: right lobe hepatectomy (5109 patients), trisegmental hepatectomy (2449 patients), pancreaticoduodenectomy (Whipple) (16 793 patients), and esophagectomy (7941 patients).
For 34 114 patients, median (interquartile range [IQR]) age was 63 (55-71) years and 42% were female. Patients undergoing CRS/HIPEC tended to be younger, with a median age of 57 years, and esophagectomy had the highest median (IQR) American Society of Anesthesiologists classification (3 [3-3]). When compared with CRS/HIPEC, higher complication rates were reported in the following categories: (1) superficial incisional infection in Whipple and esophagectomy (5.4% [95% CI, 4.4%-6.4%] vs 9.7% [95% CI, 9.3%-10.1%] and 7.2% [95% CI, 6.6%-7.8%], respectively; P < .001); (2) deep incisional infection in Whipple (1.7% [95% CI, 1.1%-2.3%] vs 2.7% [95% CI, 2.5%-2.9%]; P < .01); (3) organ space infection in right lobe hepatectomy (7.2% [95% CI, 6.0%-8.4%] vs 9.0% [95% CI, 8.2%-9.8%]; P = .02), trisegmental hepatectomy (12.4% [95% CI, 11.1%-13.7%]; P < .001), and Whipple (12.9% [95% CI, 12.4%-13.4%]; P < .001); and (4) return to the operating room for esophagectomy (6.8% [95% CI, 5.6%-8.0%] vs 14.4% [95% CI, 13.6%-15.2%]; P < .001). Median (IQR) length of hospital stay was lower in CRS/HIPEC (8 [5-11] days) than Whipple (10 [7-15] days) and esophagectomy (10 [8-16] days) (P < .001). Overall 30-day mortality was lower in CRS/HIPEC (1.1%; 95% CI, 0.6%-1.6%) compared with Whipple (2.5%; 95% CI, 2.3%-2.7%), right lobe hepatectomy (2.9%; 95% CI, 2.4%-3.4%), esophagectomy (3.0%; 95% CI, 2.6%-3.4%), and trisegmental hepatectomy (3.9%; 95% CI, 3.1%-4.7%) (P < .001).
Comparative analysis revealed CRS/HIPEC to be safe, often safer across the spectrum of NSQIP safety metrics when compared with similar-risk oncologic procedures. Patient selection was important in achieving observed outcomes. High complication rates are a misperception from early CRS/HIPEC experience and should no longer deter referral of patients to experienced centers or impede clinical trial development in the United States.
目前,美国符合细胞减灭术联合腹腔热灌注化疗(CRS/HIPEC)条件的腹膜转移患者转诊率较低,部分原因是对高发病率和死亡率的误解。然而,需要进行类似并发症发生率的主要胃肠道手术的患者会被常规转诊。
评估 CRS/HIPEC 的相对安全性。
设计、设置和参与者:回顾性队列研究纳入了 2005 年 1 月 1 日至 2015 年 12 月 31 日期间在国家外科质量改进计划(NSQIP)数据库中接受 CRS/HIPEC、右半肝切除术、三叶肝切除术、胰十二指肠切除术和食管切除术的 34114 例患者,其中包括 CRS/HIPEC(1822 例)、右半肝切除术(5109 例)、三叶肝切除术(2449 例)、胰十二指肠切除术(Whipple)(16793 例)和食管切除术(7941 例)。数据分析于 2018 年进行。
使用 NSQIP 数据库的数据比较了 CRS/HIPEC(1822 例)与其他公认的高风险肿瘤手术的围手术期和 30 天术后发病率和死亡率:右半肝切除术(5109 例)、三叶肝切除术(2449 例)、胰十二指肠切除术(Whipple)(16793 例)和食管切除术(7941 例)。
对于 34114 例患者,中位(四分位距[IQR])年龄为 63(55-71)岁,42%为女性。接受 CRS/HIPEC 的患者年龄较年轻,中位年龄为 57 岁,食管切除术的美国麻醉医师协会(ASA)分级最高(3 [3-3])。与 CRS/HIPEC 相比,以下分类报告的并发症发生率较高:(1)Whipple 和食管切除术的浅表切口感染(5.4% [95%CI,4.4%-6.4%] vs 9.7% [95%CI,9.3%-10.1%]和 7.2% [95%CI,6.6%-7.8%];P<0.001);(2)Whipple 的深部切口感染(1.7% [95%CI,1.1%-2.3%] vs 2.7% [95%CI,2.5%-2.9%];P<0.01);(3)右半肝切除术的器官空间感染(7.2% [95%CI,6.0%-8.4%] vs 9.0% [95%CI,8.2%-9.8%];P=0.02)、三叶肝切除术(12.4% [95%CI,11.1%-13.7%];P<0.001)和 Whipple(12.9% [95%CI,12.4%-13.4%];P<0.001);(4)食管切除术的再次手术率(6.8% [95%CI,5.6%-8.0%] vs 14.4% [95%CI,13.6%-15.2%];P<0.001)。CRS/HIPEC 的中位(IQR)住院时间为 8 [5-11]天,低于 Whipple(10 [7-15]天)和食管切除术(10 [8-16]天)(P<0.001)。整体 30 天死亡率在 CRS/HIPEC 中较低(1.1%;95%CI,0.6%-1.6%),与 Whipple(2.5%;95%CI,2.3%-2.7%)、右半肝切除术(2.9%;95%CI,2.4%-3.4%)、食管切除术(3.0%;95%CI,2.6%-3.4%)和三叶肝切除术(3.9%;95%CI,3.1%-4.7%)相比(P<0.001)。
对比分析显示,CRS/HIPEC 是安全的,在 NSQIP 安全性指标方面,通常比类似风险的肿瘤手术更安全。患者选择对于获得观察到的结果很重要。高并发症发生率是早期 CRS/HIPEC 经验的误解,不应再阻止患者转诊至经验丰富的中心,或阻碍美国的临床试验发展。