SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC

NCT ID: NCT06202690

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2031-06-30

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.

Conditions

Robotics; Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Single-port robotic-assisted thoracic surgery

Intervention Type: PROCEDURE

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.

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.

Group Type: PLACEBO_COMPARATOR

Single-port video-assisted thoracoscopic surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

SP-RATS; SP-VATS

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Korea University Guro Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyun Koo Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

JunHee Lee

Role: CONTACT

lee2632@naver.com

01072579550

Other Identifiers

2023GR0429

Identifier Type: -

Identifier Source: org_study_id