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NCT Number: NCT07828938

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

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.

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Key information

Conditions

Lung Cancer (Non-Small Cell) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QualitySurg List

Other

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.

Primary outcomes

  1. Proportion of Confirmed R0 Resections

    Time frame: Perioperative

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

Secondary outcomes

  1. QualitySurg list Implementation and Adoption

    Time frame: During surgery

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

  2. Medium-Term Oncological Results

    Time frame: 2 years after surgery

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

  3. Quality of the Surgical Procedure

    Time frame: 30 and 90 days after surgery

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

  4. Sociological and Collaborative Aspects

    Time frame: During surgery

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Imène TRIAKI

CONTACT

[email protected]

0033140942330

Olaf MERCIER

CONTACT

[email protected]

0033140948695

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: QualitySurg

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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