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NCT Number: NCT07818135

Comparison of Biportal Versus Multiportal Robotic Approaches for Pulmonary Resection in NSCLC

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.

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Key information

Conditions

Non-small Cell Lung Cancer 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

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location status: Recruiting

Location contact

Carlos Déniz Armengol, MD, PhD

CONTACT

[email protected]

+34 932607500 ext. 2744

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Biportal Robotic-Assisted Thoracic Surgery

Procedure

Pulmonary resection performed with a biportal robotic-assisted thoracic surgery approach using two access incisions.

Multiportal Robotic-Assisted Thoracic Surgery

Procedure

Pulmonary resection performed with a multiportal robotic-assisted thoracic surgery approach using multiple access ports.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intraoperative Blood Loss

    Time frame: During surgery

    Estimated intraoperative blood loss in milliliters.

  2. Length of Hospital Stay

    Time frame: From surgery through hospital discharge, up to 30 days

    Number of days from surgery to medical discharge.

  3. Postoperative Pain Intensity (Visual Analog Scale)

    Time frame: 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.

  4. Neuropathic Pain (Douleur Neuropathique 4 Questionnaire)

    Time frame: 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.

  5. Health Status (EuroQol 5-Dimension 5-Level Questionnaire)

    Time frame: 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.

  6. Global Health Status/Quality of Life (EORTC QLQ-C30)

    Time frame: 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.

  7. Patient-Reported Lung Cancer Symptoms (EORTC QLQ-LC13)

    Time frame: 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.

  8. Postoperative Healthcare Procedures

    Time frame: From surgery through hospital discharge, up to 30 days

    Number of additional medical procedures required during the index hospitalization, including chest-drain management interventions.

Study contacts

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

Carlos Déniz Armengol, MD, PhD

CONTACT

[email protected]

+34 932607500 ext. 2744

Sponsors and collaborators

Lead sponsor

Carlos Déniz

Other

Registry information

Official study title

Clinical Trial in Patients With Non-Small Cell Lung Cancer Undergoing Biportal Versus Multiportal Robotic Thoracic Surgery: Comparison of Two Innovative Techniques

Acronym: EC-UMUR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 14, 2026
Registry last updated
Sep 14, 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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