RATT Vs. VATT for Early-stage TETs

Официальное название

Robotic-assisted Versus Video-assisted Thoracoscopic Thymectomy for Thymic Epithelial Tumor in Stage I-II: a Prospective, Multi-center, Randomized Controlled Trial

Обзор

This study is a prospective, multicenter, phase II randomized controlled trial. We plan to screen 100 eligible thymoma patients for robotic-assisted thoracoscopic thymectomy (RATT) or video-assisted thoracoscopic thymectomy (VATT) at three medical centers in China. The trial was aimed to compare the perioperative outcomes between the two approaches.

Вмешательства

• Процедура RATT
  Robotic-assisted thoracoscopic thymectomy (RATT) will be performed using Da Vinci Robotic Surgical Systems.
• Процедура VATT
  Video-assisted thoracoscopic thymectomy (VATT) was performed using traditional thoracoscopic systems.

Первичные конечные точки

• Postoperative draingage volume [Срок оценки: Up to 7 days.]

Вторичные конечные точки (12)

• complete recestion rate [Срок оценки: Up to 7 days.]
• the counts of lymph node sampling [Срок оценки: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.]
• operative time [Срок оценки: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.]
• bleeding volume [Срок оценки: From the time at start of the surgery to the time at end of the surgery. Up to 7 days.]
• duration of drainage [Срок оценки: from the day of the surgery to the day of removal of drainage tubes. Up to 7 days.]
• postoperative hospital stays [Срок оценки: from the day of the surgery to the day of discharge. Up to 30 days]
• re-operation rate [Срок оценки: from the day of the surgery to the day of discharge. Up to 7 days]
• C-reactive protein level at postoperaive day 1 [Срок оценки: from the day of the surgery to the day of discharge. Up to 7 days]
• C-reactive protein level at postoperaive day 2 [Срок оценки: from the day of the surgery to the day of discharge. Up to 7 days]
• serum interleukin-6 level at postoperaive day 1 [Срок оценки: from the day of the surgery to the day of discharge. Up to 7 days]
• serum interleukin-6 level at postoperaive day 2 [Срок оценки: from the day of the surgery to the day of discharge. Up to 7 days]
• serum procalcitonin level at postoperaive day 1 [Срок оценки: from the day of the surgery to the day of discharge. Up to 7 days]

Критерии участия

Критерии включения

• Thymoma was diagnosed by chest enhanced CT or MRI (clinical stage: Masaoka Koga I-II) with AJCC/UICC TNM grade system (9th edition).

The patients whose tumor diameter was not larger than 8 cm; The patients with the estimated survival time should be over 12 months; ASA grade：1-2; The patients should have no functional disorders in main organs; The patients should be able to understand our research and sign the informed consent.

Критерии исключения

• Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis; Patients with myasthenia gravis; Patients had undergone a sternotomy; The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control; The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy; Female who is positive for serum pregnancy test or during lactation period; The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation; The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders; The patients attend other clinical trials.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Wang S, Zhu J, Sun Z, Jiang J, Wu B, Liang F, Zheng Y, Yang X, Jiang X, Ao YQ, Gao J, Tan L, Qi Y, Yue W, Ding J. Robot-assisted versus video-assisted thoracoscopic thymectomy for stage I-II thymic epithelial tumour: a protocol for the first multicentre, randomised controlled clinical trial. BMJ Open. 2025 May 28;15(5):e095802. doi: 10.1136/bmjopen-2024-095802. PMID 40441770

Идентификаторы

NCT: NCT06654830 · KY2024455

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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