Short- and Mid-term Therapeutic, Prognostic, and Societal Impact of Implementing Intraoperative Assessment of Pulmonary Resection Quality for Lung Cancer

N/ANot Yet RecruitingNCT07828938

Fondation Hôpital Saint-Joseph2,400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

2,400

Conditions

Lung Cancer (Non-Small Cell)

Interventions

QualitySurg ListOTHER

The QualitySurg List is a collaborative intraoperative quality assessment tool for lung cancer surgery that combines a checklist, a to-do list, and a reporting system. The intervention includes implementation of the QualitySurg List, training of operating room personnel, access to a dedicated digital application integrated within the Epithor platform, and performance feedback through benchmarking of quality indicators. The tool is designed to support real-time assessment and documentation of surgical quality and to improve achievement of oncologically complete (R0) resections.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (20)

CHU Angers

Angers, France

Avicennes

Bobigny, France

CHU Bordeaux

Bordeaux, France

CLCC Jean Perrin

Clermont-Ferrand, France

CHU Dijon

Dijon, France

Hôpital Marie Lannelongue

Le Plessis-Robinson, France

CHU Lille

Lille, France

Chu Lyon

Lyon, France

Hôpital Nord

Marseille, France

CHU Nantes

Nantes, France

...and 10 more locations

Outcomes

Primary Outcomes

Proportion of Confirmed R0 Resections

R0 status assessed according to IASLC 2020 criteria using centralized pathology review and independent adjudication.

Time frame: Perioperative

Secondary Outcomes

QualitySurg list Implementation and Adoption

Measure individual and collective adherence to the list (usage rate, level of completeness).

Time frame: During surgery

Medium-Term Oncological Results

overall survival (OS) and disease-free survival (DFS) at 2 years, and proportion of local or metastatic recurrences at 2 years.

Time frame: 2 years after surgery

Quality of the Surgical Procedure

Evaluate the impact on intraoperative and post-operative complications (morbidity, mortality, length of stay, especially in intensive care).

Time frame: 30 and 90 days after surgery

Sociological and Collaborative Aspects

Evaluate the impact on: * Interprofessional communication : obeservations, semi-structured interviews, self-administred questionnaire (Likert scale) * Team engagement: obeservations, semi-structured interviews, self-administred questionnaire (Likert scale) * Acceptability of the list in the operating room: obeservations, semi-structured interviews, self-administred questionnaire (Likert scale)