Short- and Mid-term Therapeutic, Prognostic, and Societal Impact of Implementing Intraoperative Assessment of Pulmonary Resection Quality for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,400
- 试验地点
- 20
- 主要终点
- Proportion of Confirmed R0 Resections
研究概览
简要总结
QUALITYSURG is a multicenter interventional study evaluating whether a collaborative intraoperative quality checklist (QualitySurg List) can improve the oncological quality of lung cancer resections. The study includes three phases: a Delphi consensus to define checklist contents, a cluster-randomized trial comparing checklist use versus standard care, and a prospective implementation phase assessing long-term adoption. The primary endpoint is the proportion of confirmed R0 resections according to 2020 IASLC criteria.Two optional ancillary studies are embedded within the main protocol. BIO-QualitySurg aims to evaluate biological markers of residual disease and develop the concept of a biological R0 resection using circulating tumor DNA (ctDNA), tissue biomarkers, and integrated molecular analyses. BIO-QualitySurg is complementary to the objectives of the European REALCARE project, which investigates ctDNA-based approaches for residual disease assessment and personalized cancer management. VIDEO-QualitySurg contributes to the broader objective of improving quality assessment and standardization of thoracic oncologic surgery through digital technologies and artificial intelligence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Have solid NSCLC clinical stage IA-IIIA (according to the 9th edition of the TNM) and be eligible for surgical resection.
- •Have a respiratory function and a state of performance (ECOG) allowing the surgical procedure.
- •Primary intervention for NSCLC, whether isolated or included in a multimodal regimen (neoadjuvant/adjuvant).
- •Intervention can be performed by minimally invasive surgery (VATS, RATS) or by thoracotomy.
- •Have given written informed consent.
排除标准
- •History of cancer less than five years old excluding non-melanocytic skin cancer prior to enrollment
- •Pure ground glass opacities regardless of tumor size
- •iterative re-interventions of the same stay (keep only the first planned intervention for the main analysis)
- •History of HIV infection, allogeneic stem cell or solid organ transplant
- •History of any hematological disease that is not considered to be in complete remission
- •Patients under guardianship or conservatorship
- •Patients deprived of their liberty or under judicial protection
- •Pregnant women
研究组 & 干预措施
QualitySurg Implementation Strategy
Centers assigned to the intervention arm will first participate in a baseline control period during which eligible patients undergo lung cancer surgery according to usual practice without use of the QualitySurg list. During a subsequent intervention period, centers will implement the QualitySurg list, a structured intraoperative quality assessment tool combining a checklist, a to-do list, and a reporting system, supported by training, digital reporting tools, and performance feedback. Following completion of the randomized trial phase, centers will enter a prospective implementation phase in which continued, partial, modified, or discontinued use of the QualitySurg list will be observed under routine clinical practice conditions in order to assess maintenance of use and long-term adoption.
干预措施: QualitySurg List (Other)
Standard Surgical Practice
Centers assigned to the control arm will continue their usual surgical practice throughout the randomized trial phase without implementation of the QualitySurg list. Following completion of the randomized trial phase, the QualitySurg list will be made available to these centers. During the subsequent prospective implementation phase, uptake, integration, patterns of use, and adoption of the QualitySurg list will be evaluated under routine clinical practice conditions without any mandatory requirement for implementation.
结局指标
主要结局
Proportion of Confirmed R0 Resections
时间窗: Perioperative
R0 status assessed according to IASLC 2020 criteria using centralized pathology review and independent adjudication.
次要结局
- Medium-Term Oncological Results(2 years after surgery)
- QualitySurg list Implementation and Adoption(During surgery)
- Quality of the Surgical Procedure(30 and 90 days after surgery)
- Sociological and Collaborative Aspects(During surgery)