Clinical trial NCT06202690: SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC
Official title: Single-POrt Robotic Versus Video-assisted Thoracic Surgery Anatomical Pulmonary Resection for Patients With Non-small Cell Lung Cancer (SPORTS Study): a Single-center, Single-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Robotics
Lung Cancer
Keywords: sing-port surgery, robotic-assisted thoracic surgery, lung cancer
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is a single-center, single blinded, randomized controlled trial). Participants will be randomized in a 1:1 ratio to either to single-port video-assisted thoracoscopic surgery (SP-VATS) or single-port robotic-assisted thoracic surgery (SP-RATS).
Primary purpose: TREATMENT

Brief summary: Single-POrt Robotic-assisted thoracic surgery versus single-port video-assisted Thoracic Surgery major pulmonary resection for patients with non-small cell lung cancer (SPORTS trial): a single-center, a single blinded, randomized controlled trial

Detailed description: Investigators initially began single-port robotic thoracic surgery using the SP robotic system for simple procedures, such as thymectomy and mediastinal mass excision. As their expertise grew, they expanded to more complex procedures, including major pulmonary resection and esophagectomy. However, the long-term outcomes of SP robotic anatomical pulmonary resection using the SP robotic system have not yet been studied.

The aim of this study is to compare the short-term and long-term outcomes of SP robotic anatomical pulmonary resection using the SP robotic system with those of single-port video-assisted thoracoscopic surgery (SP-VATS) anatomical pulmonary resection.

This trial is a single-center, single-blinded, randomized controlled trial. Participants will be randomized at a 1:1 ratio to either single-port video-assisted thoracoscopic surgery (SP-VATS) or single-port robotic thoracic surgery.

Eligibility criteria: Inclusion Criteria:

* Candidate for anatomical pulmonary resection (segmentectomy or lobectomy) via minimally invasive thoracic surgery (RATS or VATS) for patient with non-small cell lung cancer or suspected malignant lesion.
* Age ≥ 18 years
* Patients who can comply with the requirements of the clinical trial and who, or their legal representatives, provide written consent before the start of the clinical trial
* Patients with the nationality of South Korea
* American Society of Anesthesiologists score 1-3.
* Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)

Exclusion Criteria:

* Patients who require surgery for accompanying other organ diseases
* Tumor invasion into the chest wall, diaphragm, another lobe or diaphragm
* Patients who are considered unsuitable based on the researcher's judgment
* Patients with cognitive impairments who are unable to understand the instructions and informed consent of this study
* Patients who specifically desire a certain surgical method (robotic, thoracoscopic, open thoracotomy)
* Patients who previously undergone a thoracic surgical procedure in the hemithorax to be operated on
* Pathological results other than NSCLC (ex, benign nodules, metastatic lung cancer, SCLC)
* Patients who received neoadjuvant therapy.
* Candidate for pneumonectomy, bilobectomy, lobectomy plus segmentectomy, non-anatomic resection (ex, wedge resection).
* History of other cancers in the past 5 years.

Primary outcomes:
measure: Postoperative complications
timeFrame: Postoperative complications : within 30 days after surgery
measure: Questionnaires for HRQOL of life (EQ-5D-5L) at month 3
timeFrame: at month 3 after surgery
measure: Questionnaires for HRQOL of life (EQ-VAS) at month 3
timeFrame: at month 3 after surgery
measure: Postoperative pain
timeFrame: during hospitalization
Secondary outcomes:
measure: Questionnaires for HRQOL of life (EQ-5D-5L)
timeFrame: At 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
measure: Questionnaires for HRQOL of life (EQ-VAS)
timeFrame: At 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
measure: Questionnaires for HRQOL of life (LCQ)
timeFrame: at 1 month, 3 months, and 6 months after surgery.
measure: Perioperative outcomes (Conversion rate)
timeFrame: during hospitalization
measure: Perioperative outcomes (number of lymph nodes harvested)
timeFrame: during hospitalization
measure: Perioperative outcomes (total operative time)
timeFrame: during hospitalization
measure: Perioperative outcomes (duration of chest tube drainage, postoperative hospital stays)
timeFrame: during hospitalization
measure: Perioperative outcomes (transfusion rate)
timeFrame: within 30 days after surgery.
measure: Perioperative outcomes (estimated blood loss )
timeFrame: during surgery
measure: 5-year overall survival and disease-free survival
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References: