Buxbaum James, Ko Chris, Varghese Nino, Lee Alice, Sahakian Ara, King Kevin, Serna Jessica, Lee Helen, Tchelepi Hisham, Van Dam Jacques, Duddalwar Vinay
Department of Medicine, Division of Gastroenterology, University of Southern California Keck School of Medicine, Los Angeles, California.
Department of Medicine, Division of Gastroenterology, University of Southern California Keck School of Medicine, Los Angeles, California.
Clin Gastroenterol Hepatol. 2020 Apr;18(4):917-925.e4. doi: 10.1016/j.cgh.2019.08.054. Epub 2019 Sep 6.
BACKGROUND & AIMS: Endoscopic ultrasound (EUS) is a sensitive method to evaluate the pancreas but its diagnostic capability for several diseases is limited. We compared the diagnostic yield of unenhanced EUS with that of contrast-enhanced EUS for focal pancreas lesions and identified and tested quantitative parameters of contrast enhancement.
We performed a prospective tandem-controlled trial in which 101 patients with focal pancreas lesions (48 with masses, 28 with cysts, and 25 with pancreatitis) underwent conventional EUS followed by contrast EUS using intravenous perflutren microspheres. The diagnosis at each stage was scored and compared with a standard (findings from surgical pathology analysis, cytologic, and/or 6-month clinical follow-up evaluations). Quantitative parameters were generated by time-intensity curve analysis. Solid lesions were divided into derivation and testing cohorts for a crossover validation analysis of the quantitative parameters. The primary outcome was diagnostic yield of unenhanced vs contrast EUS in analysis of focal pancreas lesions.
Contrast increased the diagnostic yield of EUS from 64% (65/101 lesions accurately assessed) to 91% (92/101 lesions accurately assessed); the odds ratio [OR] was 7.8 (95% CI, 2.7-30.2) for accurate analysis of lesions by contrast-enhanced EUS relative to unenhanced EUS. The contrast increased accuracy of analysis of pancreas masses (OR, 6.0; 95% CI, 1.8-31.8), improving assessment of neuroendocrine and other (non-carcinoma) tumors. Contrast increased the diagnostic yield for pancreas cysts to 96% (27/28) compared with 71.4% (20/28) for unenhanced EUS (P = .02), due to improved differentiation of mural nodules vs debris. Time-intensity curve analysis revealed distinct patterns of relative peak enhancement (rPE) and in-slope (rIS) for different lesions following contrast injection: for adenocarcinomas, values were low rPE and low rIS; for neuroendocrine masses, values were high rPE and normal IS; and for chronic pancreatitis foci, values were normal rPE and low rIS. In the validation cohort, these parameters correctly characterized 91% of lesions and improved yield relative to unenhanced EUS (OR, 10; 95% CI, 1.4-34.0).
Contrast-enhanced EUS improves the accuracy of analysis of focal pancreas lesions, compared with unenhanced EUS. Integration of practical quantitative parameters, specifically relative peak enhancement and in-slope, might increase the diagnostic accuracy of contrast EUS. ClinicalTrials.gov no: 02863770.
内镜超声（EUS）是评估胰腺的一种敏感方法，但其对多种疾病的诊断能力有限。我们比较了未增强EUS与对比增强EUS对胰腺局灶性病变的诊断率，并确定和测试了对比增强的定量参数。
我们进行了一项前瞻性串联对照试验，101例胰腺局灶性病变患者（48例肿块、28例囊肿和25例胰腺炎）先接受传统EUS检查，然后使用静脉注射全氟丙烷微球进行对比增强EUS检查。对每个阶段的诊断进行评分，并与标准（手术病理分析、细胞学和/或6个月临床随访评估结果）进行比较。通过时间-强度曲线分析生成定量参数。实性病变分为推导队列和测试队列，对定量参数进行交叉验证分析。主要结局是在分析胰腺局灶性病变时未增强EUS与对比增强EUS的诊断率。
对比剂使EUS的诊断率从64%（准确评估65/101个病变）提高到91%（准确评估92/101个病变）；对比增强EUS相对于未增强EUS准确分析病变的优势比[OR]为7.8（95%CI，2.7 - 30.2）。对比剂提高了胰腺肿块分析的准确性（OR，6.0；95%CI，1.8 - 31.8），改善了神经内分泌肿瘤和其他（非癌性）肿瘤的评估。对比剂使胰腺囊肿的诊断率提高到96%（27/28），而未增强EUS为71.4%（20/28）（P = 0.02），这是由于壁结节与碎屑的鉴别得到改善。时间-强度曲线分析显示，注射对比剂后不同病变的相对峰值增强（rPE）和斜率（rIS）有不同模式：腺癌的rPE值低且rIS值低；神经内分泌肿块的rPE值高且IS值正常；慢性胰腺炎病灶的rPE值正常且rIS值低。在验证队列中，这些参数正确表征了91%的病变，相对于未增强EUS提高了诊断率（OR，10；95%CI，1.4 - 34.0）。
与未增强EUS相比，对比增强EUS提高了胰腺局灶性病变分析的准确性。整合实用的定量参数，特别是相对峰值增强和斜率，可能会提高对比增强EUS的诊断准确性。ClinicalTrials.gov编号：02863770。
