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PIPAC 联合附加手术的可行性和安全性:PLUS 研究。

Feasibility and safety of PIPAC combined with additional surgical procedures: PLUS study.

机构信息

Candiolo Cancer Institute, FPO - IRCCS, Candiolo, Turin, Italy.

Department of Visceral Surgery, Lausanne University Hospital CHUV, University of Lausanne (UNIL), Switzerland.

出版信息

Eur J Surg Oncol. 2022 Oct;48(10):2212-2217. doi: 10.1016/j.ejso.2022.05.001. Epub 2022 May 7.

DOI:10.1016/j.ejso.2022.05.001
PMID:35577665
Abstract

BACKGROUND

PIPAC (Pressurized IntraPeritoneal Aerosol Chemotherapy) is a minimally invasive approach relying on physical principles for improving intraperitoneal drug delivery, including optimizing the homogeneity of drug distribution through an aerosol. Feasibility and safety of the new approach are now consolidated and data on its effectiveness are continuously increasing. Although any surgical procedure associated with PIPAC had always been discouraged due to the high risk of complications, surgical practice is constantly changing: with growing expertise, more and more surgical teams associate PIPAC with surgery.

METHODS

PLUS study is part of the retrospective international cohort studies including 10 centers around the world (India, Italy, France, Germany, Belgium, Russia, Saudi Arabia, Switzerland) and 96 cases of combined approaches evaluated through a propensity score analysis.

RESULTS

the procedures most frequently associated with PIPAC were not only adhesiolysis, omentectomy, adnexectomy, umbilical/inguinal hernia repairs, but also more demanding procedures such as intestinal resections, gastrectomy, splenectomy, bowel repair/stoma creation. Although the evidence is currently limited, PLUS study demonstrated that PIPAC associated with additional surgical procedures is linked to an increase of surgical time (p < 0.001), length of stay (p < 0.001) and medical complication rate (p < 0.001); the most frequently reported medical complications were mild or moderate in severity, such as abdominal pain, nausea, ileus and hyperthermia. No difference in terms of surgical complications was registered; neither reoperation or postoperative deaths were reported.

CONCLUSIONS

these results suggest that PIPAC can be safely combined in expert centers with additional surgeries. Widespread change of practice should be discouraged before the results of ongoing prospective studies are available.

摘要

背景

PIPAC(腹腔内加压气溶胶化疗)是一种微创方法,依靠物理原理来改善腹腔内药物输送,包括通过气溶胶优化药物分布的均匀性。新方法的可行性和安全性现已得到巩固,其有效性数据不断增加。尽管由于并发症风险高,任何与 PIPAC 相关的手术都不被鼓励,但手术实践正在不断变化:随着专业知识的增长,越来越多的手术团队将 PIPAC 与手术结合使用。

方法

PLUS 研究是一项回顾性国际队列研究的一部分,包括全球 10 个中心(印度、意大利、法国、德国、比利时、俄罗斯、沙特阿拉伯、瑞士),并通过倾向评分分析评估了 96 例联合方法的病例。

结果

与 PIPAC 最常联合进行的手术不仅包括粘连松解术、网膜切除术、附件切除术、脐疝/腹股沟疝修补术,还包括更具挑战性的手术,如肠切除术、胃切除术、脾切除术、肠修复/造口术。尽管目前证据有限,但 PLUS 研究表明,与额外手术联合使用 PIPAC 与手术时间增加(p<0.001)、住院时间延长(p<0.001)和医疗并发症发生率增加(p<0.001)有关;报告的医疗并发症最常见的是轻度或中度,如腹痛、恶心、肠梗阻和发热。在手术并发症方面没有差异;也没有报告再次手术或术后死亡。

结论

这些结果表明,在有经验的中心,PIPAC 可以安全地与其他手术联合使用。在正在进行的前瞻性研究结果公布之前,应避免广泛改变实践。

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