经基于共识的算法在经食管镜最小侵入性食管癌手术后诊断吻合口漏效果的表现。
Performance of a consensus-based algorithm for diagnosing anastomotic leak after minimally invasive esophagectomy for esophageal cancer.
发表日期:2023 Mar 28
作者:
Jobbe Lemmens, Bastiaan Klarenbeek, Moniek Verstegen, Frans van Workum, Gerjon Hannink, Sander Ubels, Camiel Rosman
来源:
Protein & Cell
摘要:
吻合口漏(AL)是食管切除手术后常见且严重的并发症。本研究旨在评估一种基于共识的算法在微创食管切除术后诊断AL的表现。本研究使用ICAN试验的数据,这是一项多中心随机临床试验,比较颈部和胸内吻合术,在其中使用预先定义的诊断算法指导AL的诊断。该算法根据临床表现、血清C反应蛋白(截止值为200毫克/升)和/或引流液淀粉酶(截止值为200国际单位/升)来鉴定疑似AL的患者。怀疑AL会促使使用造影吞咽计算机断层扫描和/或内窥镜进行确认。主要结果指标是算法的敏感性、特异性和阳性和阴性预测值(PPV,NPV)。AL的定义根据食管切除并发症共识组的定义。共包括245例患者,125例(51%)患者疑似AL。在最初评估中,该算法具有62%(95%信任区间[CI]:46-75)的敏感性,97%(95%CI:89-100)的特异性,以及94%(95%CI:79-99)和77%(95%CI:66-86)的PPV和NPV。对于仍然怀疑AL的19例患者进行重复评估,尽管最初评估结果为阴性或不确定,但其敏感性为100%(95%CI:77-100)。该算法表现欠佳,因为低敏感性意味着该算法无法在最初评估中确认AL。需要使用算法进行重复评估以确认剩余的漏洞。©2023年作者。由牛津大学出版社代表食管疾病国际学会出版。保留所有权利。有关权限,请发送电子邮件至journals.permissions@oup.com。
Anastomotic leak (AL) is a common and severe complication after esophagectomy. This study aimed to assess the performance of a consensus-based algorithm for diagnosing AL after minimally invasive esophagectomy. This study used data of the ICAN trial, a multicenter randomized clinical trial comparing cervical and intrathoracic anastomosis, in which a predefined diagnostic algorithm was used to guide diagnosing AL. The algorithm identified patients suspected of AL based on clinical signs, blood C-reactive protein (cut-off value 200 mg/L), and/or drain amylase (cut-off value 200 IU/L). Suspicion of AL prompted evaluation with contrast swallow computed tomography and/or endoscopy to confirm AL. Primary outcome measure was algorithm performance in terms of sensitivity, specificity, and positive and negative predictive values (PPV, NPV), respectively. AL was defined according to the definition of the Esophagectomy Complications Consensus Group. 245 patients were included, and 125 (51%) patients were suspected of AL. The algorithm had a sensitivity of 62% (95% confidence interval [CI]: 46-75), a specificity of 97% (95% CI: 89-100), and a PPV and NPV of 94% (95% CI: 79-99) and 77% (95% CI: 66-86), respectively, on initial assessment. Repeated assessment in 19 patients with persisting suspicion of AL despite negative or inconclusive initial assessment had a sensitivity of 100% (95% CI: 77-100). The algorithm showed poor performance because the low sensitivity indicates the inability of the algorithm to confirm AL on initial assessment. Repeated assessment using the algorithm was needed to confirm remaining leaks.© The Author(s) 2023. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please email: journals.permissions@oup.com.