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NCT Number: NCT06202690

SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC

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

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Key information

Conditions

Robotics Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Other names: SP-VATS

Primary outcomes

  1. Postoperative complications

    Time frame: Postoperative complications : within 30 days after surgery

    complications will be classified according to Clavien-Dindo classfication

  2. Questionnaires for HRQOL of life (EQ-5D-5L) at month 3

    Time frame: at month 3 after surgery

    Questionnaires for HRQOL of life (EQ-5D-5L) will be administered at months 3.

  3. Questionnaires for HRQOL of life (EQ-VAS) at month 3

    Time frame: at month 3 after surgery

    Questionnaires for HRQOL of life (EQ-5D-5L, EQ-VAS) will be administered at months 3.

  4. Postoperative pain

    Time frame: during hospitalization

    Pain levels were assessed and recorded using the VAS score more than three times daily during the hospitalization period.

Secondary outcomes

  1. Questionnaires for HRQOL of life (EQ-5D-5L)

    Time frame: 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.

  2. Questionnaires for HRQOL of life (EQ-VAS)

    Time frame: 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.

  3. Questionnaires for HRQOL of life (LCQ)

    Time frame: 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.

  4. Perioperative outcomes (Conversion rate)

    Time frame: during hospitalization

    Conversion rate = conversion to open thoracotomy / total number of surgery

  5. Perioperative outcomes (number of lymph nodes harvested)

    Time frame: during hospitalization

    Total number of lymph nodes harvested during the surgical procedure.

  6. Perioperative outcomes (total operative time)

    Time frame: during hospitalization

    the time taken from skin incision to completion of skin closure

  7. Perioperative outcomes (duration of chest tube drainage, postoperative hospital stays)

    Time frame: 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

  8. Perioperative outcomes (transfusion rate)

    Time frame: 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.

  9. Perioperative outcomes (estimated blood loss )

    Time frame: during surgery

    estimated measurement of intraoperative blood loss (ml)

  10. 5-year overall survival and disease-free survival

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

JunHee Lee

CONTACT

[email protected]

01072579550

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study 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

Acronym: SPORTS

Important dates

Study start
2024
Primary completion
2026
Study completion
2031
First posted
Jan 11, 2024
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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