SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Postoperative complications [Срок оценки: Postoperative complications : within 30 days after surgery]
• Questionnaires for HRQOL of life (EQ-5D-5L) at month 3 [Срок оценки: at month 3 after surgery]
• Questionnaires for HRQOL of life (EQ-VAS) at month 3 [Срок оценки: at month 3 after surgery]
• Postoperative pain [Срок оценки: during hospitalization]

Вторичные конечные точки (10)

• Questionnaires for HRQOL of life (EQ-5D-5L) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: at 1 month, 3 months, and 6 months after surgery.]
• Perioperative outcomes (Conversion rate) [Срок оценки: during hospitalization]
• Perioperative outcomes (number of lymph nodes harvested) [Срок оценки: during hospitalization]
• Perioperative outcomes (total operative time) [Срок оценки: during hospitalization]
• Perioperative outcomes (duration of chest tube drainage, postoperative hospital stays) [Срок оценки: during hospitalization]
• Perioperative outcomes (transfusion rate) [Срок оценки: within 30 days after surgery.]
• Perioperative outcomes (estimated blood loss ) [Срок оценки: during surgery]
• 5-year overall survival and disease-free survival [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06202690 · 2023GR0429

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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