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

NCT07818135 | Recruiting FDA Device

• 1 other identifier: HUB-CTO-2024-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Robotic-Assisted Thoracic Surgery; Pulmonary Resection; biRATS; multiRATS

Outcome Measures

Primary Outcomes (1)

• 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.

  From surgery through hospital discharge, up to 30 days

Secondary Outcomes (8)

• Intraoperative Blood Loss

  During surgery

• Length of Hospital Stay

  From surgery through hospital discharge, up to 30 days

• Postoperative Pain Intensity (Visual Analog Scale)

  From baseline through 12 months after surgery

• Neuropathic Pain (Douleur Neuropathique 4 Questionnaire)

  From baseline through 12 months after surgery

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

  From baseline through 12 months after surgery

Study Arms (2)

biRATS

EXPERIMENTAL

Biportal robotic-assisted thoracic surgery for pulmonary resection using two access incisions.

Procedure: Biportal Robotic-Assisted Thoracic Surgery

multiRATS

ACTIVE COMPARATOR

Multiportal robotic-assisted thoracic surgery for pulmonary resection using multiple access ports.

Procedure: Multiportal Robotic-Assisted Thoracic Surgery

Interventions

Biportal Robotic-Assisted Thoracic Surgery PROCEDURE

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

biRATS

Multiportal Robotic-Assisted Thoracic Surgery PROCEDURE

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

multiRATS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carlos Déniz: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Carlos Déniz Armengol, MD, PhD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Déniz Armengol, MD, PhD

CONTACT

+34 932607500; cjdeniz@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are partially masked to the allocated surgical approach by standardized dressings maintained for 48 hours after surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Thoracic Surgeon

Model Details: Two-arm parallel-group trial comparing biportal RATS with multiportal RATS for pulmonary resection.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 14, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)