SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC (SPORTS)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer; Robotics
• Intervention / Treatment: Procedure: Single-port robotic-assisted thoracic surgery; Procedure: Single-port video-assisted thoracoscopic surgery

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 Type: Interventional
• Enrollment (Estimated): 290
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JunHee Lee; Phone Number: 01072579550; Email: lee2632@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SP-RATS; 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.	Procedure: Single-port robotic-assisted thoracic surgery; All patients : 145 patients Single-port anatomical pulmonary resection(segmentectomy, lobectomy) with a complete mediastinal lymph node dissection 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.; Other Names: SP-RATS
Placebo Comparator: SP-VATS; 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.	Procedure: Single-port video-assisted thoracoscopic surgery; All patients : 145 patients Single-port anatomical pulmonary resection(segmentectomy, lobectomy) with a complete mediastinal lymph node dissection will be performed using the VATS. A 4-cm single incision will be made at 5th intercostal space. A chest tube will be inserted in same incision.; Other Names: SP-VATS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 9, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: January 1, 2024
• First Posted (Estimated): January 11, 2024

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: sing-port surgery, robotic-assisted thoracic surgery, lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2023GR0429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No