Non-Small Cell Lung Cancer
Conditions
Keywords
Robotic-Assisted Thoracic Surgery, Pulmonary Resection, biRATS, multiRATS
Brief summary
This study compares two established robotic surgical approaches for removing lung tumors in adults with non-small cell lung cancer: biportal robotic-assisted thoracic surgery (biRATS) and multiportal robotic-assisted thoracic surgery (multiRATS). Participants are assigned at random to one of the two approaches. The study will compare surgical safety, recovery after surgery, pain, length of hospital stay, quality of life, and other clinical outcomes during 12 months of follow-up.
Detailed description
Robotic-assisted thoracic surgery is widely used for pulmonary resection in patients with resectable non-small cell lung cancer. Multiportal RATS uses several access ports. Biportal RATS uses two access incisions and aims to preserve minimally invasive benefits while improving ergonomic access and instrument maneuverability. This single-center, prospective, randomized, partially blinded clinical trial will compare biRATS with multiRATS in adults undergoing pulmonary resection with curative intent at Hospital Universitari de Bellvitge. Eligible participants who provide written informed consent will be randomly assigned using the study REDCap randomization system. A standardized dressing will be maintained for 48 hours after surgery to support partial blinding. The main analysis will compare intraoperative and immediate postoperative complications between groups. Additional assessments include intraoperative blood loss, conversion, chest-drain duration, hospital length of stay, postoperative pain, readmission, mortality, and health-related quality of life. Quality of life will be assessed using EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13; pain will be measured with a visual analogue scale and DN4 questionnaire. Follow-up occurs during hospitalization and at 1, 6, and 12 months after surgery. The planned sample is 70 to 80 participants (approximately 35 per group). The study is investigator initiated and has CEIm approval (PR208/24; protocol version 3.0 dated June 18, 2025).
Interventions
PROCEDUREBiportal Robotic-Assisted Thoracic Surgery
Pulmonary resection performed with a biportal robotic-assisted thoracic surgery approach using two access incisions.
PROCEDUREMultiportal Robotic-Assisted Thoracic Surgery
Pulmonary resection performed with a multiportal robotic-assisted thoracic surgery approach using multiple access ports.
Sponsors
Carlos Déniz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are partially masked to the allocated surgical approach by standardized dressings maintained for 48 hours after surgery.
Intervention model description
Two-arm parallel-group trial comparing biportal RATS with multiportal RATS for pulmonary resection.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older, of any sex. * Non-small cell lung cancer considered clinically resectable, confirmed preoperatively or during surgery. * Candidate for pulmonary resection by robotic thoracic surgery. * Written informed consent.
Exclusion criteria
* Declines participation or cannot provide written informed consent. * Thoracic anatomical abnormalities that preclude or materially affect robotic surgery. * Active thoracic infection. * Surgery not performed by a participating surgeon with comparable experience in biRATS and multiRATS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intraoperative and Immediate Postoperative Complications | From surgery through hospital discharge, up to 30 days | Proportion of participants with intraoperative or immediate postoperative complications, classified by Clavien-Dindo grade. Events include, among others, prolonged air leak, pleuropulmonary infection, pneumothorax, postoperative hemorrhage, chylothorax, respiratory failure, wound infection, readmission, and perioperative death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Blood Loss | During surgery | Estimated intraoperative blood loss in milliliters. |
| Length of Hospital Stay | From surgery through hospital discharge, up to 30 days | Number of days from surgery to medical discharge. |
| Postoperative Pain Intensity (Visual Analog Scale) | From baseline through 12 months after surgery | Pain intensity measured using the Visual Analog Scale (VAS), a 0 to 10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. |
| Neuropathic Pain (Douleur Neuropathique 4 Questionnaire) | From baseline through 12 months after surgery | Neuropathic pain assessed using the Douleur Neuropathique 4 (DN4) questionnaire, scored from 0 to 10. Scores of 4 or higher are consistent with neuropathic pain; higher scores indicate a greater likelihood of neuropathic pain. |
| Health Status (EuroQol 5-Dimension 5-Level Questionnaire) | From baseline through 12 months after surgery | Health status assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) descriptive system. Five dimensions are each rated from 1 (no problems) to 5 (extreme problems); lower levels indicate better health status. |
| Global Health Status/Quality of Life (EORTC QLQ-C30) | From baseline through 12 months after surgery | Global health status/quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/QoL scale, transformed to a 0 to 100 score; higher scores indicate better global health status/quality of life. |
| Patient-Reported Lung Cancer Symptoms (EORTC QLQ-LC13) | From baseline through 12 months after surgery | Lung cancer-related symptoms assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13). Symptom scores are transformed to 0 to 100; higher scores indicate greater symptom burden. |
| Postoperative Healthcare Procedures | From surgery through hospital discharge, up to 30 days | Number of additional medical procedures required during the index hospitalization, including chest-drain management interventions. |
Countries
Spain
Contacts
CONTACTCarlos Déniz Armengol, MD, PhD
PRINCIPAL_INVESTIGATORCarlos Déniz Armengol, MD, PhD
Hospital Universitari de Bellvitge
Outcome results
None listed