SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC

Not Applicable

Not yet recruiting

• Conditions: Robotics; Lung Cancer
• Interventions: Procedure: Single-port robotic-assisted thoracic surgery; Procedure: Single-port video-assisted thoracoscopic surgery

• Registration Number: NCT06202690
• Lead Sponsor: Korea University Guro Hospital

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.

Study Timeline

• Study First Submitted: 2023-11-09
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-01
• Last Update Submitted: 2024-01-01
• Study Start: 2024-01-09
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Primary Completion: 2026-06-30
• Study Completion: 2031-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 290

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SP-RATS	Single-port robotic-assisted thoracic surgery	SP-RATS Arm: 145 patients, single-port anatomical pulmonary resection will be performed using the SP robotic system. A 4-cm single incision will be made below the subcostal margin. A chest tube will be inserted in same incision.
SP-VATS	Single-port video-assisted thoracoscopic surgery	SP-VATS Arm: 145 patients, single-port anatomical pulmonary resection was performed using VATS. A 4-cm incision will be made at 5th intercostal space on the anterior or posterior axillary line. A chest tube will be inserted in same incision.

Primary Outcome Measures

Name	Time	Method
Questionnaires for HRQOL of life (EQ-5D-5L) at month 3	at month 3 after surgery	Questionnaires for HRQOL of life (EQ-5D-5L) will be administered at months 3.
Questionnaires for HRQOL of life (EQ-VAS) at month 3	at month 3 after surgery	Questionnaires for HRQOL of life (EQ-5D-5L, EQ-VAS) will be administered at months 3.
Postoperative pain	during hospitalization	Pain levels were assessed and recorded using the VAS score more than three times daily during the hospitalization period.
Postoperative complications	Postoperative complications : within 30 days after surgery	complications will be classified according to Clavien-Dindo classfication

Secondary Outcome Measures

Name	Time	Method
Questionnaires for HRQOL of life (EQ-VAS)	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.	Questionnaires for HRQOL of life (EQ-5D-5L, EQ-VAS) will be administered 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.
Questionnaires for HRQOL of life (LCQ)	at 1 month, 3 months, and 6 months after surgery.	Questionnaires for HRQOL of life (LCQ) will be administered at 1 month, 3 months, and 6 months after surgery.
Perioperative outcomes (number of lymph nodes harvested)	during hospitalization	Total number of lymph nodes harvested during the surgical procedure.
Perioperative outcomes (Conversion rate)	during hospitalization	Conversion rate = conversion to open thoracotomy / total number of surgery
Perioperative outcomes (estimated blood loss )	during surgery	estimated measurement of intraoperative blood loss (ml)
5-year overall survival and disease-free survival	5 years	Overall survival (OS) is defined as the time from randomization to death. Disease-free survival (DFS) is defined as the time from randomization to recurrence of tumor or death.
Perioperative outcomes (total operative time)	during hospitalization	the time taken from skin incision to completion of skin closure
Perioperative outcomes (transfusion rate)	within 30 days after surgery.	The transfusion rate was defined as the percentage of patients who received an allogeneic blood transfusion within 30 days after surgery.
Questionnaires for HRQOL of life (EQ-5D-5L)	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.	Questionnaires for HRQOL of life (EQ-5D-5L, EQ-VAS) will be administered 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.
Perioperative outcomes (duration of chest tube drainage, postoperative hospital stays)	during hospitalization	duration of chest tube drainage: the time from the date of the operation to the date of chest tube removal; postoperative hospital stays: the time from the date of the operation to the date of discharge