Department of Gastrointestinal Surgery, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.
Department of General, Hepatobiliary Surgery and Liver Transplantation, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.
Eur J Surg Oncol. 2024 Jun;50(6):108346. doi: 10.1016/j.ejso.2024.108346. Epub 2024 Apr 18.
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.
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.
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.
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.
加压腹腔内气溶胶化疗（PIPAC）是一种用于腹膜转移患者微创药物给药的程序。以前的研究强调了治疗方案一致性和该实践标准化的重要性。本研究旨在就 PIPAC 的资格、患者选择和化疗选择达成共识。
进行了三轮改良 Delphi 研究。指导小组制定了一份基本陈述清单，以解决目标。指导小组由七名外科和肿瘤医学专家组成。对可用证据和已发表的关键意见进行了批判性审查。国际专家小组对这些陈述进行了 4 分李克特量表评分。陈述以电子方式匿名提交。如果同意率≥75%，则达成共识。设定最小 Cronbach's alpha 为>0.8。
45 名（45/58；77.6%）专家参与并完成了所有轮次。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）、肿瘤内科医生（n=4）和一名临床研究员。他们对第一轮的 81 条初步陈述进行了评估，得出了 41 条合并陈述。在第二轮，有 40 条陈述（40/41；97.6%）达成共识，每条陈述的共识率均≥80%。在第三轮，40 条陈述一致被批准为最终陈述。一线和二线化疗的选择仍然存在争议，无法达成共识。
这项国际 Delphi 研究为 PIPAC 的资格和患者选择提供了实用指南。正在进行的试验数据和可能有助于进一步标准化 PIPAC 的长期结果备受期待。
