Non-Small Cell Lung CancerEC-UMURNCT07818135
Comparison of Biportal Versus Multiportal Robotic Approaches for Pulmonary Resection in NSCLC
A study testing Biportal Robotic-Assisted Thoracic Surgery and Multiportal Robotic-Assisted Thoracic Surgery in people with Non-Small Cell Lung Cancer, run by Carlos Déniz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Biportal Robotic-Assisted Thoracic Surgery and Multiportal Robotic-Assisted Thoracic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Carlos Déniz Armengol, MD, PhD, +34 932607500 ext. 2744, cjdeniz@bellvitgehospital.cat
About this study
Official title: Clinical Trial in Patients With Non-Small Cell Lung Cancer Undergoing Biportal Versus Multiportal Robotic Thoracic Surgery: Comparison of Two Innovative Techniques
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.
Read the 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).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Biportal Robotic-Assisted Thoracic Surgery, Multiportal Robotic-Assisted Thoracic Surgery
- Keywords
- Robotic-Assisted Thoracic Surgery, Pulmonary Resection, biRATS, multiRATS
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biportal Robotic-Assisted Thoracic SurgeryProcedure or surgery
Pulmonary resection performed with a biportal robotic-assisted thoracic surgery approach using two access incisions.
Multiportal Robotic-Assisted Thoracic SurgeryProcedure or surgery
Pulmonary resection performed with a multiportal robotic-assisted thoracic surgery approach using multiple access ports.
| Study group | Role | What they receive |
|---|---|---|
| biRATS | Experimental | Biportal robotic-assisted thoracic surgery for pulmonary resection using two access incisions. Receives: Procedure: Biportal Robotic-Assisted Thoracic Surgery |
| multiRATS | Active comparator | Multiportal robotic-assisted thoracic surgery for pulmonary resection using multiple access ports. Receives: Procedure: Multiportal Robotic-Assisted Thoracic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intraoperative and Immediate Postoperative Complications
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.
Measured: From surgery through hospital discharge, up to 30 days
Secondary outcomes (8)
Intraoperative Blood Loss
Estimated intraoperative blood loss in milliliters.
Measured: During surgery
Length of Hospital Stay
Number of days from surgery to medical discharge.
Measured: From surgery through hospital discharge, up to 30 days
Postoperative Pain Intensity (Visual Analog Scale)
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.
Measured: From baseline through 12 months after surgery
Neuropathic Pain (Douleur Neuropathique 4 Questionnaire)
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.
Measured: From baseline through 12 months after surgery
Health Status (EuroQol 5-Dimension 5-Level Questionnaire)
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.
Measured: From baseline through 12 months after surgery
Global Health Status/Quality of Life (EORTC QLQ-C30)
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.
Measured: From baseline through 12 months after surgery
Patient-Reported Lung Cancer Symptoms (EORTC QLQ-LC13)
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.
Measured: From baseline through 12 months after surgery
Postoperative Healthcare Procedures
Number of additional medical procedures required during the index hospitalization, including chest-drain management interventions.
Measured: From surgery through hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Jan 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel-group trial comparing biportal RATS with multiportal RATS for pulmonary resection.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carlos Déniz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carlos Déniz, Hospital Universitari de Bellvitge
- Investigators
- Carlos Déniz Armengol, MD, PhD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818135
- Sponsor's protocol ID
- HUB-CTO-2024-01
- Acronym
- EC-UMUR
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared because of data-protection and institutional-governance requirements.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial in Patients With Non-Small Cell Lung Cancer Undergoing Biportal Versus Multiportal Robotic Thoracic Surgery: Comparison of Two Innovative Techniques
- ClinicalTrials.gov ID
- NCT07818135
- Acronym / sponsor ID
- EC-UMUR / HUB-CTO-2024-01
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Robotic-Assisted Thoracic Surgery, Pulmonary Resection, biRATS, multiRATS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Carlos DénizUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two-arm parallel-group trial comparing biportal RATS with multiportal RATS for pulmonary resection.
| Arm | Type | Receives |
|---|---|---|
| biRATS | Experimental | Procedure: Biportal Robotic-Assisted Thoracic SurgeryBiportal robotic-assisted thoracic surgery for pulmonary resection using two access incisions. |
| multiRATS | Active comparator | Procedure: Multiportal Robotic-Assisted Thoracic SurgeryMultiportal robotic-assisted thoracic surgery for pulmonary resection using multiple access ports. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biportal Robotic-Assisted Thoracic SurgeryPulmonary resection performed with a biportal robotic-assisted thoracic surgery approach using two access incisions. | Procedure or surgery | biRATS |
| Multiportal Robotic-Assisted Thoracic SurgeryPulmonary resection performed with a multiportal robotic-assisted thoracic surgery approach using multiple access ports. | Procedure or surgery | multiRATS |
Primary outcome
Incidence of Intraoperative and Immediate Postoperative Complications
Time frame: 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.
8 secondary outcomes
Intraoperative Blood Loss
Time frame: During surgery
Length of Hospital Stay
Time frame: From surgery through hospital discharge, up to 30 days
Postoperative Pain Intensity (Visual Analog Scale)
Time frame: From baseline through 12 months after surgery
Neuropathic Pain (Douleur Neuropathique 4 Questionnaire)
Time frame: From baseline through 12 months after surgery
Health Status (EuroQol 5-Dimension 5-Level Questionnaire)
Time frame: From baseline through 12 months after surgery
Global Health Status/Quality of Life (EORTC QLQ-C30)
Time frame: From baseline through 12 months after surgery
Patient-Reported Lung Cancer Symptoms (EORTC QLQ-LC13)
Time frame: From baseline through 12 months after surgery
Postoperative Healthcare Procedures
Time frame: From surgery through hospital discharge, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of data-protection and institutional-governance requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Déniz Armengol, MD, PhD principal investigator
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biportal Robotic-Assisted Thoracic Surgery and Multiportal Robotic-Assisted Thoracic Surgery in people with Non-Small Cell Lung Cancer, run by Carlos Déniz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Déniz Armengol, MD, PhD (+34 932607500 ext. 2744, cjdeniz@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intraoperative and Immediate Postoperative Complications (time frame: From surgery through hospital discharge, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.