SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC

Lung Cancer Clinical Trial

— SPORTS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06202690
• Other study ID #: 2023GR0429
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: June 30, 2031

Study information

• Verified date: January 2024
• Source: Korea University Guro Hospital
• Contact: JunHee Lee
• Phone: 01072579550
• Email: lee2632[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 290
• Est. completion date: June 30, 2031
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Robotics

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	complications will be classified according to Clavien-Dindo classfication	Postoperative complications : within 30 days after surgery
Primary	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
Primary	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
Primary	Postoperative pain	Pain levels were assessed and recorded using the VAS score more than three times daily during the hospitalization period.	during hospitalization
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Perioperative outcomes (Conversion rate)	Conversion rate = conversion to open thoracotomy / total number of surgery	during hospitalization
Secondary	Perioperative outcomes (number of lymph nodes harvested)	Total number of lymph nodes harvested during the surgical procedure.	during hospitalization
Secondary	Perioperative outcomes (total operative time)	the time taken from skin incision to completion of skin closure	during hospitalization
Secondary	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
Secondary	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.
Secondary	Perioperative outcomes (estimated blood loss )	estimated measurement of intraoperative blood loss (ml)	during surgery
Secondary	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