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腹腔内化疗治疗假性黏液瘤腹膜假性黏液瘤的细胞减灭术与腹腔内化疗的学习曲线和手术表现的多中心研究。

Multicentre study of the learning curve and surgical performance of cytoreductive surgery with intraperitoneal chemotherapy for pseudomyxoma peritonei.

机构信息

Peritoneal Surface Malignancy Programme, Colorectal Cancer Unit, IRCCS Fondazione Istituto Nazionale Tumori di Milano, Milan, Italy.

出版信息

Br J Surg. 2014 Dec;101(13):1758-65. doi: 10.1002/bjs.9674. Epub 2014 Oct 20.

DOI:10.1002/bjs.9674
PMID:25329419
Abstract

BACKGROUND

The learning curves for cytoreductive surgery with intraperitoneal chemotherapy for treatment of pseudomyxoma peritonei (PMP) were explored between international centres/surgeons to identify institutional or other factors that might affect performance.

METHODS

Data from patients with PMP treated with the combined procedure across 33 international centres between 1993 and 2012 were analysed retrospectively. A risk-adjusted sequential probability ratio test was conducted after defining the target outcome as early oncological failure (disease progression within 2 years of treatment), an acceptable risk for the target outcome (odds ratio) of 2, and type I/II error rates of 5 per cent. The risk prediction model was elaborated and patients were evaluated sequentially for each centre/surgeon. The learning curve was considered to be overcome and proficiency achieved when the odds ratio for early oncological failure became smaller than 2.

RESULTS

Rates of optimal cytoreduction, severe postoperative morbidity and early oncological failure were 84·4, 25·7 and 29·0 per cent respectively. The median annual centre volume was 17 (range 6-66) peritoneal malignancies. Only eight of the 33 centres and six of 47 surgeons achieved proficiency after a median of 100 (range 78-284) and 96 (86-284) procedures respectively. The most important institutional factor affecting surgical performance was centre volume.

CONCLUSION

The learning curve is extremely long, so centralization and/or networking of centres is necessary to assure quality of services. One centre for every 10-15 million inhabitants would be ideal.

摘要

背景

为了确定可能影响手术表现的机构或其他因素,探索了国际中心/外科医生之间进行细胞减灭术联合腹腔内化疗治疗假性黏液瘤腹膜(PMP)的学习曲线。

方法

回顾性分析了 1993 年至 2012 年间 33 个国际中心治疗 PMP 的患者数据。在定义目标结局为早期肿瘤失败(治疗后 2 年内疾病进展)后,进行了风险调整的序贯概率比检验,目标结局的可接受风险(比值比)为 2,I 型/II 型错误率为 5%。阐述了风险预测模型,并对每个中心/外科医生进行了序贯评估。当早期肿瘤失败的比值比小于 2 时,认为学习曲线已被克服且达到熟练水平。

结果

最佳肿瘤减灭率、严重术后发病率和早期肿瘤失败率分别为 84.4%、25.7%和 29.0%。中心每年腹膜恶性肿瘤的中位数为 17 例(范围 6-66 例)。33 个中心中只有 8 个,47 个外科医生中有 6 个,在中位数为 100 例(范围 78-284 例)和 96 例(范围 86-284 例)后达到熟练水平。影响手术表现的最重要机构因素是中心容量。

结论

学习曲线极其漫长,因此需要集中和/或联网中心以确保服务质量。每 1000-1500 万居民有一个中心是理想的。

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