背景:隔离肢体灌注(ILP)是一种公认的外科手术,用于向肢体施用大剂量化疗以治疗晚期肢体恶性肿瘤。尽管ILP技术在60多年前首次被描述,ILP在相对较少的专业中心使用,与三级或四级癌症中心位于同一地点。高剂量细胞毒性化疗和细胞因子肿瘤坏死因子α(TNFα)的组合,要求泄漏监测,以防止潜在的严重全身毒性。由于该程序是在相对较少的专家中心进行的,成立了一个ILP工作组,旨在为该程序制定技术共识准则,以简化实践并为开始使用该技术的新中心提供指导。
方法:在2021年10月至2023年10月之间,举行了一系列面对面的在线和混合会议,其中使用了经过修改的Delphi流程来制定统一的共识文件。每次会议后,对文件进行了修改和重新分发,然后在随后的会议上进行了重新讨论,直到在所有建议中达成了90%以上的共识。
结果:完成的共识文件包括23个主题,其中达成了90%以上的共识,83%的建议在工作组所有成员中都有100%的共识。共识建议涵盖外科手术的所有领域,包括术前评估,药物剂量和给药,灌注参数,热疗,泄漏监测和剧院物流,实用的手术策略以及术后护理,反应评估和员工培训。
结论:我们就ILP的技术方面提出了第一个基于专家的联合共识声明,可以作为现有和新中心提供ILP的参考点。
BACKGROUND: Isolated limb perfusion (ILP) is a well-established surgical procedure for the administration of high dose chemotherapy to a limb for the treatment of advanced extremity malignancy. Although the technique of ILP was first described over 60 years ago, ILP is utilised in relatively few specialist centres, co-located with tertiary or quaternary cancer centres. The combination of high dose cytotoxic chemotherapy and the cytokine tumour necrosis factor alpha (TNFα), mandates leakage monitoring to prevent potentially serious systemic toxicity. Since the procedure is performed at relatively few specialist centres, an ILP working group was formed with the aim of producing technical consensus
guidelines for the procedure to streamline practice and to provide guidance for new centres commencing the technique.
METHODS: Between October 2021 and October 2023 a series of face to face online and hybrid meetings were held in which a modified Delphi process was used to develop a unified consensus document. After each meeting the document was modified and recirculated and then rediscussed at subsequent meeting until a greater than 90% consensus was achieved in all recommendations.
RESULTS: The completed
consensus document comprised 23 topics in which greater than 90%
consensus was achieved, with 83% of recommendations having 100%
consensus across all members of the working group. The
consensus recommendations covered all areas of the surgical procedure including pre-operative assessment, drug dosing and administration, perfusion parameters, hyperthermia, leakage monitoring and theatre logistics, practical surgical strategies and also post-operative care, response evaluation and staff training.
CONCLUSIONS: We present the first joint expert-based
consensus statement with respect to the technical aspects of ILP that can serve as a reference point for both existing and new centres in providing ILP.