Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
512 participants
OBSERVATIONAL
2023-07-15
2027-12-30
Brief Summary
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Detailed Description
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The LARCS study is designed to understand the perioperative outcomes of patients and identify the real-world selection process of either VATS and RATS segmentectomy and lobectomy for lung cancers ≤2 cm. It aims to generate evidence to support integration of patient-centered care using minimally invasive technology.
In addition, health related quality of life captured in the study will also provide valuable insight into time to recovery, determining burden of the disease, and guide future treatment strategy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Robotic Assisted Thoracic Surgery
Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy.
Robotic Assisted Thoracic Surgery
Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.
Video Assisted Thoracic Surgery
Participants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy.
Video Assisted Thoracic Surgery
Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.
Interventions
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Robotic Assisted Thoracic Surgery
Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.
Video Assisted Thoracic Surgery
Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.
Eligibility Criteria
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Inclusion Criteria
* Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci robotic assisted surgery or VATs
* Aged ≥ 18 years
* Must be willing and able to comply with study requirements
* Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form
Exclusion Criteria
* Patient receiving a lobectomy/segmentectomy as an emergency procedure
* Patients receiving a lobectomy/segmentectomy for metastatic cancer
* Patients scheduled to receive a bilobectomy or sleeve-lobectomy
* Mental incapacity to understand or consent to study procedures
* Anticipated difficulty for patient to comply with protocol requirements
* Unable to comply with the follow up schedule
* Pregnant or are planning to become pregnant during the study
* Life expectancy \< 12 months
18 Years
ALL
No
Sponsors
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Intuitive Surgical
INDUSTRY
Responsible Party
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Principal Investigators
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Tom Routledge
Role: PRINCIPAL_INVESTIGATOR
Guy's St Thomas' NHS Foundation Trust, UK
Rune Eggum
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Akershus
Martin Eichhorn
Role: PRINCIPAL_INVESTIGATOR
Thoraxklinik Heidelberg, Germany
Locations
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AP-HM
Marseille, , France
CHU de Rouen
Rouen, , France
CHU de Toulouse
Toulouse, , France
Thoraxklinik
Heidelberg, , Germany
Krankenhaus Barmherzige Brüder
Regensburg, , Germany
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Akershus University Hospital
Loerenskog, , Norway
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, , United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
St Bartholomew Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Pascal-Alexandre THOMAS
Role: primary
Jean Marc Baste
Role: primary
Laurent Brouchet
Role: primary
Martin Eichhorn
Role: primary
Hans-Stefan Hofmann
Role: primary
Carmelina Cristina, Zirafa
Role: primary
Rune, Eggum
Role: primary
Igor Saftic
Role: primary
Luis Hernandez
Role: primary
Tom Routledge
Role: primary
Steven Stamenkovic
Role: primary
References
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Patel YS, Hanna WC, Fahim C, Shargall Y, Waddell TK, Yasufuku K, Machuca TN, Pipkin M, Baste JM, Xie F, Shiwcharan A, Foster G, Thabane L. RAVAL trial: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer. PLoS One. 2022 Feb 2;17(2):e0261767. doi: 10.1371/journal.pone.0261767. eCollection 2022.
Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3.
Related Links
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Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer
Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial.
Other Identifiers
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1114332C
Identifier Type: -
Identifier Source: org_study_id
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