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To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.
Detection of lung cancer is occurring at increasingly earlier stages due to improved screening and the discovery of incidental nodules. Coinciding with this trend is recent data from two international randomized, control trials, RAVAL - (Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer) and, JCOG0802 (The Japan Clinical Oncology Group) that show oncologic outcomes from segmentectomy are equivalent to lobectomy for cancers ≤2 cm. However, segmentectomy is a more complex technical operation that may not be easily feasible using video assisted thoracic surgery (VATS) but could be facilitated by robotic-assisted thoracic surgery (RATS), allowing improved vision, precision and controlled anatomic dissection.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Assisted Thoracic Surgery | Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy. |
| |
| Video Assisted Thoracic Surgery | Participants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Assisted Thoracic Surgery | Procedure | Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported Quality of Life 1 | EQ 5D 5L (European Quality of Life Five Dimension) The EQ-5D-5L is a validated and established generic Patient Reported Outcome (PRO) instrument that uses 6 questions to assess patients' quality of life. It includes a vertical EQ visual analog scale (EQ VAS, 0-100 points) and a descriptive EQ-5D-5L system. An algorithm is used to calculate the scores. For the descriptive section of the scale, an index value of 1 represents the best possible health state, while an index value of <0 (variable) represents the worst possible health state. The EQ VAS score is rated on a scale of 0-100 points. 0 points correspond to the worst possible health status, while 100 points correspond to the best possible health status. | 1 month post surgery |
| Patient reported Quality of Life 2 | RNLI (Reintegration to Normal Living Index) The RNLI has 11 questions and is scored on a visual analogue scale (VAS). On one end: "does not describe my situation" (1 or minimal integration) and "fully describes my situation" (10 or complete integration). Individual item scores are summed to provide the total score. The higher the score, the better the patients perceived integration. | 1 month post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of conversions from pre-operative surgical plan | Number of participants who undergo conversion surgery from the pre-operative surgical plan captured on the surgical decision making form. Conversion may be from segmentectomy to lobetomy, RATS or VATS to open surgery. | immediately post operative |
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Inclusion Criteria:
Exclusion Criteria:
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Data from adult participants who have a lobectomy or segmentectomy for treatment of non small cell lung cancer (clinical stages IA1-2) will be collected.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie Allouis | Contact | +33786480495 | Marie.Allouis@intusurg.com | |
| James Grainger | Contact | james.grainger@intusurg.com |
| Name | Affiliation | Role |
|---|---|---|
| Tom Routledge | Guy's St Thomas' NHS Foundation Trust, UK | Principal Investigator |
| Rune Eggum | University Hospital, Akershus | Principal Investigator |
| Martin Eichhorn |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital Rigshospitalet | Recruiting | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35108265 | Background | 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. | |
| 35461558 |
| Label | URL |
|---|---|
| Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D013906 | Thoracoscopy |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
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| Video Assisted Thoracic Surgery | Procedure | Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS. |
|
| Thoraxklinik Heidelberg, Germany |
| Principal Investigator |
| AP-HM | Recruiting | Marseille | France |
|
| CHU de Rouen | Recruiting | Rouen | France |
|
| CHU de Toulouse | Recruiting | Toulouse | France |
|
| Thoraxklinik | Recruiting | Heidelberg | Germany |
|
| Krankenhaus Barmherzige BrĂ¼der | Recruiting | Regensburg | Germany |
|
| Azienda Ospedaliero Universitaria Pisana | Recruiting | Pisa | Italy |
|
| Akershus University Hospital | Recruiting | Loerenskog | Norway |
|
| University Hospitals Bristol and Weston NHS Foundation Trust | Recruiting | Bristol | United Kingdom |
|
| University Hospitals Coventry and Warwickshire NHS Trust | Recruiting | Coventry | United Kingdom |
|
| Guy's and St Thomas' NHS Foundation Trust | Recruiting | London | SE1 9RT | United Kingdom |
|
| St Bartholomew Hospital | Recruiting | London | United Kingdom |
|
| Background |
| 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. |
| 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. | View source |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |