Long-term oncological outcomes following algorithm-based care versus usual care for the early recognition and management of complications after pancreatic resection: a post-hoc analysis of a nationwide, stepped-wedge cluster-randomised trial.

The PORSCH trial showed that an algorithm for early recognition and minimally invasive management of complications after pancreatic resection significantly improved short-term clinical outcomes.

PORSCH试验表明，一种用于早期识别和微创管理胰腺切除术后并发症的算法显著改善了短期临床结果。

The algorithm's effect on long-term survival remains to be determined.

该算法对长期生存的影响尚待确定。

Methods

Long-term oncological outcomes were evaluated post hoc in all patients included in the nationwide, stepped-wedge cluster-randomised PORSCH trial (Jan 8, 2018, to Nov 9, 2019, Netherlands Trial Register, NL6671) who underwent pancreatic resection for pancreatic ductal adenocarcinoma, distal cholangiocarcinoma, ampullary carcinoma, or duodenal carcinoma.

在荷兰全国范围内的分步楔形群组随机PORSCH试验（2018年1月8日至2019年11月9日，荷兰试验注册，NL6671）中，对所有接受胰腺切除术的胰管腺癌、远端胆管癌、壶腹癌或十二指肠癌患者进行了长期肿瘤学结果的事后评估。

Cox proportional hazard regression was used to compare overall survivalbetween algorithm-based care and usual care.

使用Cox比例风险回归比较基于算法的护理与常规护理之间的总生存。

The crude analyses accounted for the stepped-wedge design by adjusting for calendar time, hospital volume, and hospital as a frailty term.

未调整的分析通过调整日历时间、医院容量和将医院作为脆弱性项来考虑逐步楔形设计。

Adjusted analyses were adjusted for baseline factors associated with long-term survival (age at diagnosis, sex, American Society of Anesthesiologists score, preoperative carbohydrate antigen 19-9, neoadjuvant therapy, vascular resection, postoperative tumour size, number of positive lymph nodes, perineural invasion, tumour differentiation, and resection margin status).

调整分析考虑了与长期生存相关的基线因素（诊断时年龄、性别、美国麻醉医师协会评分、术前碳水化合物抗原19-9、新辅助治疗、血管切除术、术后肿瘤大小、阳性淋巴结数量、神经周围侵犯、肿瘤分化程度和切缘状态）。

Adjusted differences in restricted mean survival time (RMST) were estimated between algorithm-based care and usual care, using the same adjustment set as the Cox models.

使用与Cox模型相同的调整集，估计了基于算法的护理与常规护理之间的限制性平均生存时间（RMST）的调整差异。

A predefined subgroup analysis was performed for patients with pancreatic ductal adenocarcinoma.

对胰管腺癌患者进行了预先定义的亚组分析。

Results

In total, 1090 patients were included: 644 (59%) patients with pancreatic ductal adenocarcinoma, 175 (16%) patients with distal cholangiocarcinoma, 188 (17%) patients with ampullary carcinoma, and 83 (8%) patients with duodenal carcinoma.

共有1090名患者被纳入研究：其中644名（59%）为胰管腺癌患者，175名（16%）为远端胆管癌患者，188名（17%）为壶腹癌患者，以及83名（8%）为十二指肠癌患者。

As of Jan 1, 2024, median follow-up was 56 months (IQR 48-63) for the 549 patients who received usual care and 48 months (35-53) for the 541 patients who received algorithm-based care.

截至2024年1月1日，接受常规护理的549名患者中位随访时间为56个月（四分位数间距48-63），而接受基于算法护理的541名患者中位随访时间为48个月（四分位数间距35-53）。

Unadjusted median overall survivalwas 24 months (95% CI 22-28) in the usual care group and 26 months (24-30) in the algorithm-based care group.

未调整的总生存期中位数在常规护理组为24个月（95%置信区间22-28），在基于算法的护理组为26个月（95%置信区间24-30）。

The adjusted difference in RMST for overall survivalover 36 months was 2·1 months (95% CI 0·6-3·7, p=0·0080), favouring algorithm-based care.

在36个月的总生存期中，基于算法的护理与常规护理相比，调整后的受限平均生存时间（RMST）差异为2.1个月（95%置信区间0.6-3.7，p=0.0080），更有利于基于算法的护理。

Algorithm-based care was associated with improved overall survival(crude hazard ratio[HR] 0·85 [95% CI 0·71-1·02], p=0·076; adjusted HR 0·76 [0·62-0·93], p=0·0089).

基于算法的护理与改善的总生存期相关（未调整的风险比[HR]为0.85 [95% CI 0.71-1.02]，p=0.076；调整后的HR为0.76 [0.62-0.93]，p=0.0089）。

Overall survivaldifferences between algorithm-based care and usual care were most pronounced in patients with pancreatic ductal adenocarcinoma (crude HR 0·78 [95% CI 0·62-0·97], p=0·028; adjusted HR 0·71 [0·56-0·90], p=0·0052).

在胰腺导管腺癌患者中，基于算法的护理与常规护理之间的总生存差异最为显著（未调整的HR为0.78 [95%置信区间0.62-0.97]，p=0.028；调整后的HR为0.71 [0.56-0.90]，p=0.0052）。

For these patients, the adjusted RMST differences up to 36 months favoured algorithm-based care by 2·5 months (95% CI 0·8-4·2, p=0·0046).

对于这些患者，调整后的限制性平均生存时间（RMST）差异在36个月内，基于算法的护理比常规护理多出2.5个月（95%置信区间0.8-4.2，p=0.0046）。

interpretation

The PORSCH algorithm for early recognition and minimally invasive management of postoperative complications after pancreatic surgery is associated with increased long-term overall survivalafter resection of pancreatic or periampullary cancer.

PORSCH算法用于早期识别和微创管理胰腺手术后的并发症，与胰腺或壶腹周围癌症切除后的长期总生存率提高有关。

funding

Dutch Cancer Society and St Antonius Research Fund.

荷兰癌症协会和圣安东尼乌斯研究基金会。