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早期胆囊切除术治疗急性结石性胆囊炎的发病率和死亡率预测:S.P.Ri.M.A.C.C.研究结果。

Prediction of morbidity and mortality after early cholecystectomy for acute calculous cholecystitis: results of the S.P.Ri.M.A.C.C. study.

机构信息

Division of General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Department of Clinical, Diagnostic and Pediatric Sciences, University of Pavia, Via Alessandro Brambilla, 74, 27100, Pavia, PV, Italy.

出版信息

World J Emerg Surg. 2023 Mar 18;18(1):20. doi: 10.1186/s13017-023-00488-6.

Abstract

BACKGROUND

Less invasive alternatives than early cholecystectomy (EC) for acute calculous cholecystitis (ACC) treatment have been spreading in recent years. We still lack a reliable tool to select high-risk patients who could benefit from these alternatives. Our study aimed to prospectively validate the Chole-risk score in predicting postoperative complications in patients undergoing EC for ACC compared with other preoperative risk prediction models.

METHOD

The S.P.Ri.M.A.C.C. study is a World Society of Emergency Surgery prospective multicenter observational study. From 1st September 2021 to 1st September 2022, 1253 consecutive patients admitted in 79 centers were included. The inclusion criteria were a diagnosis of ACC and to be a candidate for EC. A Cochran-Armitage test of the trend was run to determine whether a linear correlation existed between the Chole-risk score and a complicated postoperative course. To assess the accuracy of the analyzed prediction models-POSSUM Physiological Score (PS), modified Frailty Index, Charlson Comorbidity Index, American Society of Anesthesiologist score (ASA), APACHE II score, and ACC severity grade-receiver operating characteristic (ROC) curves were generated. The area under the ROC curve (AUC) was used to compare the diagnostic abilities.

RESULTS

A 30-day major morbidity of 6.6% and 30-day mortality of 1.1% were found. Chole-risk was validated, but POSSUM PS was the best risk prediction model for a complicated course after EC for ACC (in-hospital mortality: AUC 0.94, p < 0.001; 30-day mortality: AUC 0.94, p < 0.001; in-hospital major morbidity: AUC 0.73, p < 0.001; 30-day major morbidity: AUC 0.70, p < 0.001). POSSUM PS with a cutoff of 25 (defined in our study as a 'Chole-POSSUM' score) was then validated in a separate cohort of patients. It showed a 100% sensitivity and a 100% negative predictive value for mortality and a 96-97% negative predictive value for major complications.

CONCLUSIONS

The Chole-risk score was externally validated, but the CHOLE-POSSUM stands as a more accurate prediction model. CHOLE-POSSUM is a reliable tool to stratify patients with ACC into a low-risk group that may represent a safe EC candidate, and a high-risk group, where new minimally invasive endoscopic techniques may find the most useful field of action.

TRIAL REGISTRATION

ClinicalTrial.gov NCT04995380.

摘要

背景

近年来,对于急性胆囊结石(ACC)的治疗,有一些比早期胆囊切除术(EC)更具微创性的替代方法。我们仍然缺乏一种可靠的工具来选择可能从这些替代方法中受益的高危患者。我们的研究旨在前瞻性验证 Chole 风险评分在预测接受 EC 治疗的 ACC 患者术后并发症方面的准确性,并与其他术前风险预测模型进行比较。

方法

S.P.Ri.M.A.C.C. 研究是一项世界急诊外科学会前瞻性多中心观察性研究。从 2021 年 9 月 1 日至 2022 年 9 月 1 日,纳入了 79 个中心的 1253 例连续患者。纳入标准为 ACC 诊断和 EC 候选患者。进行 Cochran-Armitage 趋势检验,以确定 Chole 风险评分与术后并发症之间是否存在线性相关性。为了评估分析的预测模型-POSSUM 生理评分(PS)、改良衰弱指数、Charlson 合并症指数、美国麻醉师协会评分(ASA)、急性生理学与慢性健康状况评分系统 II(APACHE II)评分和 ACC 严重程度分级的准确性,生成了受试者工作特征(ROC)曲线。ROC 曲线下面积(AUC)用于比较诊断能力。

结果

发现 30 天主要发病率为 6.6%,30 天死亡率为 1.1%。Chole 风险评分得到了验证,但 POSSUM PS 是预测 ACC 患者 EC 术后并发症的最佳风险预测模型(院内死亡率:AUC 0.94,p<0.001;30 天死亡率:AUC 0.94,p<0.001;院内主要发病率:AUC 0.73,p<0.001;30 天主要发病率:AUC 0.70,p<0.001)。然后在另一批患者中验证了 POSSUM PS 的截断值为 25(在我们的研究中定义为“Chole-POSSUM”评分)。它对死亡率的敏感性为 100%,对主要并发症的阴性预测值为 100%,对主要并发症的阴性预测值为 96-97%。

结论

Chole 风险评分得到了外部验证,但 CHOLE-POSSUM 是一种更准确的预测模型。CHOLE-POSSUM 是一种可靠的工具,可以将 ACC 患者分层为低风险组,这可能代表安全的 EC 候选者,以及高风险组,在那里新的微创内镜技术可能会找到最有用的作用领域。

试验注册

ClinicalTrials.gov NCT04995380。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/56c6/10024826/963efd8860af/13017_2023_488_Fig1_HTML.jpg

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