背景:腹膜内加压雾化化疗(PIPAC)是一种对腹膜转移患者进行微创药物治疗的方法。先前的研究强调了治疗方案的统一性和这种做法的标准化的重要性。这项研究旨在就资格问题达成共识,患者选择,以及PIPAC化疗的选择。
方法:进行三轮改良Delphi研究。一个指导小组制定了一份基线声明清单,实现目标。指导小组由七名外科和医学肿瘤学家组成。对现有证据和发表的关键意见进行了严格审查。一个国际专家小组对这些陈述进行了4分的李克特评分。声明以电子和匿名方式提交。如果协议率≥75%,则达成共识。设定Cronbach的最小α>0.8。
结果:45名(45/58;77.6%)专家参加并完成了所有回合。专家是消化外科医生(n=28),外科肿瘤学家(n=7),妇科医生(n=5),医学肿瘤学家(n=4),和一名临床研究员。他们在第一轮评估了81份初步报表,得出了41份合并报表。在第二轮中,就40项陈述达成共识(40/41;97.6%),每项陈述达成共识≥80%.在第三轮中,40份声明被一致批准为最终决定。一线和二线化疗的选择仍然存在争议,无法达成共识。
结论:这项国际德尔菲研究为PIPAC的资格和患者选择提供了实用指导。正在进行的试验数据和长期结果可能有助于PIPAC的进一步标准化正在热切期待。
BACKGROUND: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) is a procedure for minimally invasive drug administration in patients with peritoneal metastasis. Previous studies have emphasized the importance of uniformity in treatment protocols and standardization of this practice. This study aimed to reach a
consensus on eligibility, patient selection, and choice of chemotherapy for PIPAC.
METHODS: A three-round modified Delphi study was conducted. A steering group formulated a list of baseline statements, addressing the objectives. The steering group consisted of seven expert surgical and medical oncologists. Available evidence and published key opinions were critically reviewed. An international expert panel scored those statements on a 4-point Likert scale. The statements were submitted electronically and anonymously.
Consensus was reached if the agreement rate was ≥75%. A minimum Cronbach\'s alpha of >0.8 was set.
RESULTS: Forty-five (45/58; 77.6%) experts participated and completed all rounds. Experts were digestive surgeons (n = 28), surgical oncologists (n = 7), gynecologists (n = 5), medical oncologists (n = 4), and one clinical researcher. Their assessment of 81 preliminary statements in the first round resulted in 41 consolidated statements. In round two,
consensus was reached on 40 statements (40/41; 97.6%) with a
consensus of ≥80% for each individual statement. In the third round, 40 statements were unanimously approved as definitive. The choice of first- and second-line chemotherapy remained controversial and could not reach
consensus.
CONCLUSIONS: This International Delphi study provides practical guidance on eligibility and patient selection for PIPAC. Ongoing trial data and long-term results that could contribute to the further standardization of PIPAC are eagerly awaited.