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机器人辅助与开放胰十二指肠切除术对胰瘘发生率影响的倾向评分匹配分析

A Propensity Score-Matched Analysis of Robotic vs Open Pancreatoduodenectomy on Incidence of Pancreatic Fistula.

作者信息

McMillan Matthew T, Zureikat Amer H, Hogg Melissa E, Kowalsky Stacy J, Zeh Herbert J, Sprys Michael H, Vollmer Charles M

机构信息

Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia.

Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

出版信息

JAMA Surg. 2017 Apr 1;152(4):327-335. doi: 10.1001/jamasurg.2016.4755.

DOI:10.1001/jamasurg.2016.4755
PMID:28030724
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5470429/
Abstract

IMPORTANCE

The adoption of robotic pancreatoduodenectomy (RPD) is gaining momentum; however, its impact on major outcomes, including pancreatic fistula, has yet to be adequately compared with open pancreatoduodenectomy (OPD).

OBJECTIVE

To demonstrate that use of RPD does not increase the incidence of clinically relevant pancreatic fistula (CR-POPF) compared with OPD.

DESIGN, SETTING, AND PARTICIPANTS: Data were accrued from 2846 patients who underwent pancreatoduodenectomies (OPDs, n = 2661; RPDs, n = 185), performed by 51 surgeons at 17 institutions worldwide (2003-2015). All RPDs were conducted at a high-volume, academic, pancreatic surgery specialty center-in a standardized fashion-by surgeons who had surpassed the RPD learning curve. Propensity score matching was used to minimize bias from nonrandomized treatment assignment. The RPD and OPD cohorts were matched by propensity scores accounting for factors significantly associated with either undergoing robotic surgery or CR-POPF occurrence on logistic regression analysis. These variables included pancreatic gland texture, pancreatic duct diameter, intraoperative blood loss, pathologic findings of disease, and intraoperative drain placement.

INTERVENTIONS

Use of RPD or OPD.

MAIN OUTCOMES AND MEASURES

The major outcome of interest was CR-POPF occurrence, which is the most common and morbid complication following pancreatoduodenectomy.

RESULTS

The overall cohort was 51.5% male, with a median age of 64 years (interquartile range, 56-72 years). The propensity score-matched cohort comprised 152 RPDs and 152 OPDs; all covariate imbalances were alleviated. After adjusting for potential confounders, undergoing RPD was associated with a reduced risk for CR-POPF incidence (OR, 0.4 [95% CI, 0.2-0.7]; P = .002) relative to OPD. Other predictors of risk-adjusted CR-POPF occurrence included soft pancreatic parenchyma (OR, 4.7 [95% CI, 3.4-6.6]; P < .001), pathologic findings of high-risk disease (OR, 1.4 [95% CI, 1.1-1.9]; P = .01), small pancreatic duct diameter (vs ≥5 mm: 2 mm, OR, 2.1 [95% CI, 1.4-3.1]; P < .001; ≤1 mm, OR, 1.8 [95% CI, 1.0-3.0]; P = .03), elevated intraoperative blood loss (vs ≤400 mL: 401-700 mL, OR, 1.5 [95% CI, 1.1-2.0]; P = .01; >1000 mL, OR, 2.1 [95% CI, 1.4-2.9]; P < .001), omission of intraoperative drain(s) (OR, 0.5 [95% CI, 0.3-0.8]; P = .005), and octreotide prophylaxis (OR, 3.1 [95% CI, 2.3-4.0]; P < .001). Patients undergoing RPD demonstrated similar CR-POPF rates compared with patients in the OPD cohort (6.6% vs 11.2%; P = .23). This relationship held for both grade B (6.6% vs 9.2%; P = .52) and grade C (0% vs 2.0%; P = .25) POPFs. Robotic pancreatoduodenectomy was also noninferior to OPD in terms of the occurrence of any complication (73.7% vs 66.4%; P = .21), severe complications (Accordion grade ≥3, 23.05% vs 23.7%; P > .99), hospital stay (median: 8 vs 8.5 days; P = .31), 30-day readmission (22.4% vs 21.7%; P > .99), and 90-day mortality (3.3% vs 1.3%; P = .38).

CONCLUSIONS AND RELEVANCE

To our knowledge, this is the first propensity score-matched analysis of robotic vs open pancreatoduodenectomy to date, and it demonstrates that RPD is noninferior to OPD in terms of pancreatic fistula development and other major postoperative outcomes.

摘要

重要性

机器人胰十二指肠切除术(RPD)的应用正在加速;然而,其对包括胰瘘在内的主要结局的影响,尚未与开放性胰十二指肠切除术(OPD)进行充分比较。

目的

证明与OPD相比,使用RPD不会增加临床相关胰瘘(CR-POPF)的发生率。

设计、设置和参与者:数据来自全球17家机构的51名外科医生进行的2846例胰十二指肠切除术患者(OPD,n = 2661;RPD,n = 185)(2003 - 2015年)。所有RPD均在一家高容量的学术性胰腺外科专业中心,由已越过RPD学习曲线的外科医生以标准化方式进行。倾向评分匹配用于最小化非随机治疗分配产生的偏差。RPD和OPD队列通过倾向评分进行匹配,该评分考虑了在逻辑回归分析中与接受机器人手术或CR-POPF发生显著相关的因素。这些变量包括胰腺质地、胰管直径、术中失血、疾病的病理结果以及术中引流管放置。

干预措施

使用RPD或OPD。

主要结局和测量指标

感兴趣的主要结局是CR-POPF的发生,这是胰十二指肠切除术后最常见且最具病态的并发症。

结果

整个队列中男性占51.5%,中位年龄为64岁(四分位间距,56 - 72岁)。倾向评分匹配队列包括152例RPD和152例OPD;所有协变量不平衡均得到缓解。在调整潜在混杂因素后,与OPD相比,接受RPD与CR-POPF发生率降低相关(OR,0.4 [95% CI,0.2 - 0.7];P = .002)。风险调整后CR-POPF发生的其他预测因素包括胰腺实质柔软(OR,4.7 [95% CI,3.4 - 6.6];P < .001)、高危疾病的病理结果(OR,1.4 [95% CI,1.1 - 1.9];P = .01)、胰管直径小(与≥5 mm相比:2 mm,OR,2.1 [95% CI,1.4 - 3.1];P < .001;≤1 mm,OR,1.8 [95% CI,1.0 - 3.0];P = .03)、术中失血量增加(与≤400 mL相比:401 - 700 mL,OR,1.5 [95% CI,1.1 - 2.0];P = .01;>1000 mL,OR,2.1 [95% CI,1.4 - 2.9];P < .001)、未放置术中引流管(OR,0.5 [95% CI,0.3 - 0.8];P = .005)以及奥曲肽预防(OR,3.1 [95% CI,2.3 - 4.0];P < .001)。接受RPD的患者与OPD队列中的患者相比,CR-POPF发生率相似(6.6%对11.2%;P = .23)。这种关系在B级(6.6%对9.2%;P = .52)和C级(0%对2.0%;P = .25)POPF中均成立。在任何并发症的发生方面,机器人胰十二指肠切除术也不劣于OPD(73.7%对66.4%;P = .21)、严重并发症(手风琴分级≥3级,23.05%对23.7%;P > .99)、住院时间(中位:8天对8.5天;P = .31)、30天再入院率(22.4%对21.7%;P > .99)以及90天死亡率(3.3%对1.3%;P = .38)。

结论和相关性

据我们所知,这是迄今为止首次对机器人与开放性胰十二指肠切除术进行倾向评分匹配分析,并且表明在胰瘘发生及其他主要术后结局方面,RPD不劣于OPD。

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