基于超声剪切波弹性成像参数与临床风险因素的术后胰瘘改良预测模型

doi:10.3969/j.issn.1674-8115.2023.04.005

上海交通大学学报（医学版） ›› 2023, Vol. 43 ›› Issue (4): 437-444.doi: 10.3969/j.issn.1674-8115.2023.04.005

• 论著 · 临床研究 • 上一篇

基于超声剪切波弹性成像参数与临床风险因素的术后胰瘘改良预测模型

田晓梵¹^,²(), 董怡¹^,²(), 楼文晖³, 张琪¹, 邱艺杰¹, 左丹¹, 王文平¹

^1.复旦大学附属中山医院超声科，上海 200032
^2.上海交通大学医学院附属新华医院超声科，上海 200092
^3.复旦大学附属中山医院胰腺外科，上海 200032

收稿日期:2022-10-10 接受日期:2023-03-14 出版日期:2023-04-28 发布日期:2023-04-28
通讯作者: 董怡 E-mail:20211210103@fudan.edu.cn;drdaisydong@hotmail.com
作者简介:田晓梵（1995—），男，中国台湾，住院医师，硕士生；电子信箱：20211210103@fudan.edu.cn。
基金资助:
国家自然科学基金面上项目(82071942);上海市浦江人才计划(2020PJD008);申康促进市级医院临床技能与临床创新能力三年行动计划(SHDC2020CR1031B)

A modified clinically relevant post-operative pancreatic fistula risk evaluation model based on ultrasound shear wave elastography: a prospective study

TIAN Xiaofan¹^,²(), DONG Yi¹^,²(), LOU Wenhui³, ZHANG Qi¹, QIU Yijie¹, ZUO Dan¹, WANG Wenping¹

^1.Department of Ultrasound, Zhongshan Hospital, Fudan University, Shanghai 200032, China
^2.Department of Ultrasound, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China
^3.Department of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China

Received:2022-10-10 Accepted:2023-03-14 Online:2023-04-28 Published:2023-04-28
Contact: DONG Yi E-mail:20211210103@fudan.edu.cn;drdaisydong@hotmail.com
Supported by:
National Natural Science Foundation of China(82071942);Shanghai Pujiang Program(2020PJD008);Clinical Research Plan of Shanghai Hospital Development Center(SHDC2020CR1031B)

摘要/Abstract

摘要：

目的·基于超声剪切波弹性成像（shear wave elastography，SWE）方法定量评估胰腺组织软硬度，改良现有术后临床胰瘘（clinically relevant post-operative pancreatic fistula，CR-POPF）的预测模型。方法·前瞻性纳入拟诊为胰腺肿瘤并计划于复旦大学附属中山医院接受胰腺外科手术的患者，收集患者相关临床信息。在手术前1周内使用声触诊组织弹性成像与量化技术（virtual touch tissue imaging and quantification technology，VTIQ）测量胰腺病灶及门静脉前方胰体部正常腺体实质弹性定量剪切波速度（shear wave velocity，SWV）值。术中外科医师通过对胰腺组织的直接触诊定性评估组织质地，并将胰腺触诊结果分为质地软或中等-硬。术后3周随访期内，根据2016年国际胰瘘研究组织的标准对CR-POPF进行诊断。通过单因素和多因素Logistic回归分析围手术期CR-POPF的危险因素，并建立预测模型。通过受试者工作特征曲线（receiver-operating characteristic curve，ROC曲线）与决策曲线分析（decision curve analysis，DCA）比较改良模型与现有临床预测模型的诊断效能及临床效益。结果·2021年9月到2022年3月，共有100名患者被纳入研究，包括接受胰十二指肠切除术者33例（33.0%）及胰体尾切除术者67例（67.0%）。通过术后3周的随访发现35例（35.0%）患者并发CR-POPF。通过Logistic回归分析发现，门静脉前方胰体部实质的低SWV值［lgOR=-2.934（95%CI -4.387~-1.479），P=0.000］，较窄的主胰管内径（≤3 mm）［lgOR=0.805（95%CI 0.274~1.335），P=0.003］为胰腺切除术后并发CR-POPF的独立危险因素。基于SWE定量参数改良的风险评估模型预测CR-POPF的ROC曲线下面积达0.842，敏感度、特异度、阳性预测值、阴性预测值及似然比分别为85.7%、64.6%、70.5%、81.8%及2.422。与现有临床预测模型［胰瘘风险评分（fistula risk score，FRS）和改良胰瘘风险评分（alternative fistula risk score，a-FRS）］相比，DCA结果显示基于SWE的改良模型具有更好的临床效益。结论·结合SWE定量参数与CR-POPF临床关键危险因素的预测模型具有较高的诊断效能和临床效益，且能在术前对CR-POPF风险进行无创、定量、客观的评估。

关键词: 超声剪切波弹性成像, 胰腺切除术, 术后临床胰瘘, 预测模型, 胰瘘风险评分, 改良胰瘘风险评分

Abstract:

Objective ·To modify previous clinically relevant post-operative pancreatic fistula (CR-POPF) risk evaluation models with quantitative evaluation of pancreatic tissue stiffness by ultrasound shear wave elastography (SWE). Methods ·In this prospective study, the patients who were diagnosed as having pancreatic tumors and scheduled to undergo pancreatectomy at Zhongshan Hospital, Fudan University were initially enrolled, whose clinical information was collected. Virtual touch tissue imaging and quantification technology (VTIQ) assessment was applied to the patients within one week before the surgery to measure the shear wave velocity (SWV) of pancreatic lesions and the normal parenchyma of pancreatic body in the superficial layer of the portal vein. During the surgery, the surgeons qualitatively evaluated the stiffness of pancreases via direct palpation and divided them into soft pancreases and medium-hard pancreases. During the 3-week follow-up period after pancreatectomy, CR-POPF was diagnosed according to 2016 International Study Group of Pancreatic Fistula (ISGPF) standard. Peri-operative risk factors of CR-POPF were analyzed by univariate and multivariate Logistic regression to build the prediction model. Evaluation and comparison of diagnostic efficacy and clinical benefits among different models were then performed via receiver operating characteristic (ROC) curve and decision curve analysis (DCA). Results ·From September 2021 to March 2022, 100 patients were enrolled in this study, including 33 patients (33.0%) who received pancreaticoduodenectomy (PD) and 67 patients (67.0%) who received distal pancreatectomy. CR-POPF was diagnosed in 35 patients (35.0%) during the 3-week post-pancreatectomy follow-up. Multivariate Logistic regression analysis revealed that the SWV value of the body part of pancreatic parenchyma in the superficial layer of the portal vein [lgOR=-2.934 (95%CI -4.387?-1.479), P=0.000] and the presence of a non-dilated main pancreatic duct (≤3 mm) [lgOR=0.805 (95%CI 0.274?1.335), P=0.003] were independent risk factors that significantly correlated with the occurrence of CR-POPF after pancreatectomy. The modified model based on the SWE parameter achieved the area under the ROC curve of 0.842, with the sensitivity, the specificity, the positive predictive value, the negative predictive value and the likelihood ratio of 85.7%, 64.6%, 70.5%, 81.8% and 2.422 in predicting CR-POPF. DCA revealed a better clinical benefit of the modified model compared to the previous prediction models [fistula risk score (FRS) and alternative fistula risk score (a-FRS)]. Conclusion ·The modified model based on the SWE parameter and identified clinical risk factors can make non-invasive, quantitative and objective evaluation of CR-POPF risk before pancreatectomy, and provide sufficient diagnostic efficacy and clinical benefits.

Key words: ultrasound shear wave elastography, pancreatectomy, clinically relevant post-operative pancreatic fistula (CR-POPF), prediction model, fistula risk score (FRS), alternative fistula risk score (a-FRS)

中图分类号:

R445.1

田晓梵, 董怡, 楼文晖, 张琪, 邱艺杰, 左丹, 王文平. 基于超声剪切波弹性成像参数与临床风险因素的术后胰瘘改良预测模型[J]. 上海交通大学学报（医学版）, 2023, 43(4): 437-444.

TIAN Xiaofan, DONG Yi, LOU Wenhui, ZHANG Qi, QIU Yijie, ZUO Dan, WANG Wenping. A modified clinically relevant post-operative pancreatic fistula risk evaluation model based on ultrasound shear wave elastography: a prospective study[J]. Journal of Shanghai Jiao Tong University (Medical Science), 2023, 43(4): 437-444.

图/表 6

参考文献 15

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Index	CR-POPF positive (n=35)	CR-POPF negative (n=65)	t/χ² value	P value
Gender/n(%)			0.396	0.529
Male	16 (45.7)	34 (52.3)
Female	19 (54.3)	31 (47.7)
Age/year	57.7±14.4	60.1±12.5	0.887	0.378
BMI/(kg·m^-2)	23.5±2.9	23.1±3.3	-0.702	0.484
γ-GT>150 U·L^-1/n(%)	4 (11.4)	16 (24.6)	2.473	0.116
TAG>1.7 mmol·L^-1/n(%)	10 (28.6)	18 (27.7)	0.009	0.926
Cholesterol>5.2 mmol·L^-1/n(%)	6 (17.1)	12 (18.5)	0.027	0.870
Diabetes mellitus/n(%)	4 (11.4)	16 (24.6)	2.473	0.116
Lesion size/mm	29.6±14.8	29.8±14.1	0.081	0.935
MPD diameter≤3 mm/n(%)	29 (82.9)	36 (55.4)	7.547	0.006
SWV value/(m·s^-1)
Pancreatic parenchyma	0.86±0.18	1.24±0.45	5.941	0.000
Lesion	1.42±0.60	1.41±0.64	-0.078	0.938
Lesion-parenchyma ratio	1.69±0.72	1.24±0.68	-3.044	0.003
Surgery type/n(%)			1.293	0.256
Pancreaticoduodenectomy	9 (25.7)	24 (36.9)
Distal pancreatectomy	26 (74.3)	41 (63.1)
Surgery duration/min	178.3±66.7	195.7±80.6	1.091	0.278
Blood loss/mL	138.3±131.0	119.2±139.8	-0.664	0.508
Palpation of pancreas/n(%)			1.876	0.171
Soft	19 (54.3)	26 (40.0)
Medium-hard	16 (45.7)	39 (60.0)
Pathological diagnosis of PDAC/PASC/n(%)	13 (37.1)	37 (56.9)	3.560	0.059
FRS/point	4.9±1.3	3.8±1.8	-2.891	0.005
a-FRS/%	60.6±27.2	21.3±23.2	-7.593	0.000

Index	CR-POPF positive (n=35)	CR-POPF negative (n=65)	t/χ² value	P value
Gender/n(%)			0.396	0.529
Male	16 (45.7)	34 (52.3)
Female	19 (54.3)	31 (47.7)
Age/year	57.7±14.4	60.1±12.5	0.887	0.378
BMI/(kg·m^-2)	23.5±2.9	23.1±3.3	-0.702	0.484
γ-GT>150 U·L^-1/n(%)	4 (11.4)	16 (24.6)	2.473	0.116
TAG>1.7 mmol·L^-1/n(%)	10 (28.6)	18 (27.7)	0.009	0.926
Cholesterol>5.2 mmol·L^-1/n(%)	6 (17.1)	12 (18.5)	0.027	0.870
Diabetes mellitus/n(%)	4 (11.4)	16 (24.6)	2.473	0.116
Lesion size/mm	29.6±14.8	29.8±14.1	0.081	0.935
MPD diameter≤3 mm/n(%)	29 (82.9)	36 (55.4)	7.547	0.006
SWV value/(m·s^-1)
Pancreatic parenchyma	0.86±0.18	1.24±0.45	5.941	0.000
Lesion	1.42±0.60	1.41±0.64	-0.078	0.938
Lesion-parenchyma ratio	1.69±0.72	1.24±0.68	-3.044	0.003
Surgery type/n(%)			1.293	0.256
Pancreaticoduodenectomy	9 (25.7)	24 (36.9)
Distal pancreatectomy	26 (74.3)	41 (63.1)
Surgery duration/min	178.3±66.7	195.7±80.6	1.091	0.278
Blood loss/mL	138.3±131.0	119.2±139.8	-0.664	0.508
Palpation of pancreas/n(%)			1.876	0.171
Soft	19 (54.3)	26 (40.0)
Medium-hard	16 (45.7)	39 (60.0)
Pathological diagnosis of PDAC/PASC/n(%)	13 (37.1)	37 (56.9)	3.560	0.059
FRS/point	4.9±1.3	3.8±1.8	-2.891	0.005
a-FRS/%	60.6±27.2	21.3±23.2	-7.593	0.000

Variables	Univariate		Multivariate
Variables	lgOR (95%CI)	P value	B value	lgOR (95%CI)	P value
Gender (female)	0.115 (-0.243‒0.473)	0.530	‒	‒	‒
Age	-0.006 (-0.020‒0.007)	0.375	‒	‒	‒
BMI	0.020 (-0.036‒0.077)	0.480	‒	‒	‒
Diabetes mellitus	0.043 (-0.111‒0.918)	0.124	‒	‒	‒
γ-GT level (>150 U/L)	0.403 (-0.111‒0.918)	0.124	‒	‒	‒
Lesion size	-0.001 (-0.013‒0.012)	0.935	‒	‒	‒
MPD diameter (≤3 mm)	-0.590 (-1.027‒ -0.153)	0.008	1.852	0.805 (0.274‒1.335)	0.003
SWV of pancreatic parenchyma	-2.441 (-3.635‒ -1.248)	0.000	-6.755	-2.934 (-4.387‒ -1.479)	0.000
Palpation of pancreas (soft)	-0.251 (-0.611‒0.110)	0.173	‒	‒	‒
Surgery type (PD)	0.228 (-0.167‒0.623)	0.258	‒	‒	‒
Constant	‒	‒	4.737	2.057	0.002

Variables	Univariate		Multivariate
Variables	lgOR (95%CI)	P value	B value	lgOR (95%CI)	P value
Gender (female)	0.115 (-0.243‒0.473)	0.530	‒	‒	‒
Age	-0.006 (-0.020‒0.007)	0.375	‒	‒	‒
BMI	0.020 (-0.036‒0.077)	0.480	‒	‒	‒
Diabetes mellitus	0.043 (-0.111‒0.918)	0.124	‒	‒	‒
γ-GT level (>150 U/L)	0.403 (-0.111‒0.918)	0.124	‒	‒	‒
Lesion size	-0.001 (-0.013‒0.012)	0.935	‒	‒	‒
MPD diameter (≤3 mm)	-0.590 (-1.027‒ -0.153)	0.008	1.852	0.805 (0.274‒1.335)	0.003
SWV of pancreatic parenchyma	-2.441 (-3.635‒ -1.248)	0.000	-6.755	-2.934 (-4.387‒ -1.479)	0.000
Palpation of pancreas (soft)	-0.251 (-0.611‒0.110)	0.173	‒	‒	‒
Surgery type (PD)	0.228 (-0.167‒0.623)	0.258	‒	‒	‒
Constant	‒	‒	4.737	2.057	0.002

Model	AUROC	Sensitivity/%	Specificity/%	PPV/%	NPV/%	Likelihood ratio
FRS	0.665	42.9	80.0	68.2	58.4	2.143
a-FRS	0.744	68.6	73.9	72.4	70.2	2.622
Modified model	0.842	85.7	64.6	70.5	81.8	2.422

基于超声剪切波弹性成像参数与临床风险因素的术后胰瘘改良预测模型

A modified clinically relevant post-operative pancreatic fistula risk evaluation model based on ultrasound shear wave elastography: a prospective study

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