SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC

NCT06202690 | Not Yet Recruiting

• 1 other identifier: 2023GR0429
• Study Type: interventional
• Target: 290
• Locations: 0 countries
• Sites: N/A

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

Conditions

Robotics; Lung Cancer

Keywords

sing-port surgery, robotic-assisted thoracic surgery, lung cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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-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 (LCQ)

  at 1 month, 3 months, and 6 months after surgery.

• Perioperative outcomes (Conversion rate)

  during hospitalization

• Perioperative outcomes (number of lymph nodes harvested)

  during hospitalization

Study Arms (2)

SP-RATS

ACTIVE COMPARATOR

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

SP-VATS

PLACEBO COMPARATOR

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

Interventions

Single-port robotic-assisted thoracic surgery 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.

Also known as: SP-RATS

SP-RATS

Single-port video-assisted thoracoscopic surgery 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.

Also known as: SP-VATS

SP-VATS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Guro Hospital: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

JunHee Lee

CONTACT

01072579550; lee2632@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The principal investigator will explain the study at the time of consent for the surgery. Written consent will be obtained by the principal investigator or a sub-investigator. Once eligibility for surgery is confirmed, randomization will take place within 4 weeks prior to the surgery. Participants will be randomized in a 1:1 ratio to either SP-RATS or SP-VATS using a website software randomization system. While the surgeon will be informed of the group allocations, participants will remain unaware (maintaining a single-blind approach) until the completion of the follow-up period
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: January 11, 2024
• Study Start: January 9, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2031
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share