Robot-assisted vs VATS for Thymoma

Официальное название

Comparison of Short-term and Longterm Outcomes Between Robot-assisted Thoracoscopy and Television-assisted Thoracoscopy Surgery Forthymoma : a Multicenter, Prospective, Randomized Controlled Study

Обзор

The aim of this study is to explore the advantages of robot-assisted thymectomy in long-term survival benefits and short-term clinical efficacy compared with video-assisted thoracoscopic thymectomy based on a multi-center, prospective, randomized controlled clinical trial.

Подробное описание

Video-assisted thoracoscopic surgery ( VATS ) is widely used in thoracic surgery and has gradually replaced traditional thoracotomy in thymoma. As a new type of VATS, the long-term oncological results of robot-assisted thoracoscopic surgery in thymoma have not been verified. Therefore, we designed a multicenter, prospective, randomized controlled clinical trial to determine whether RATS thymectomy is as effective as VATS thymectomy in terms of short-term and long-term outcomes.

Вмешательства

• Процедура RATS for Thymectomy
  a minimally invasive surgical type for Thymoma: RATS
• Процедура VATS for Thymectomy
  a minimally invasive surgical type for Thymoma: VATS

Первичные конечные точки

• 5-year overall survival (OS) [Срок оценки: 5 year after surgery]

Вторичные конечные точки (12)

• Pain score [Срок оценки: at 1 year after surgery]
• quality of life (QOL) at 1 year by EORTC QLQ-C30 [Срок оценки: at 1 year after surgery]
• quality of life (QOL) at 1 year by EQ-5D [Срок оценки: at 1 year after surgery]
• R0 rate [Срок оценки: postoperative in-hospital stay up to 30 days]
• operative time [Срок оценки: Intraoperative]
• blood loss [Срок оценки: Intraoperative]
• conversion rate [Срок оценки: Intraoperative]
• length of hospital stay (LOS) [Срок оценки: postoperative in-hospital stay up to 30 days]
• Catheterization days [Срок оценки: postoperative in-hospital stay up to 30 days]
• Volume of drainage [Срок оценки: postoperative in-hospital stay up to 30 days]
• postoperative complications [Срок оценки: postoperative in-hospital stay up to 30 days]
• 30-day mortality [Срок оценки: postoperative in-hospital stay up to 30 days]

Критерии участия

Критерии включения

• ) The age of the subjects on the day of signing the informed consent was ≥ 18 years old and < 75 years old, regardless of gender ;
• ) Chest thin-layer CT and MR showed anterior mediastinal space-occupying lesions, combined with relevant hematological indicators, the patient was clinically diagnosed as a thymic epithelial tumor with or without myasthenia gravis ( MG ) symptoms.
• ) need to accept thymectomy surgery ;
• ) Clinical stage I to IIIA ( AJCC-UICC TNM staging system ) ;
• ) The maximum diameter of the lesion < 5cm ;
• ) physical condition score 0 or 1 ( Eastern Cooperative Oncology Group ECOG scoring system ) ;
• ) Have not received any anti-thymoma therapy before, including but not limited to systemic chemotherapy, radiotherapy, etc. ;
• ) Preoperative major organ function meets the following criteria : Bone marrow function: hemoglobin ≥ 10.0 g / dL ( no blood transfusion within 28 days before hemoglobin examination ), absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L ( no transfusion of apheresis platelets or IL-11 treatment within 14 days before platelet count examination ) ; coagulation function : INR and PT < 1.5 × ULN, APTT ≤ 1.5 × ULN ; liver function: transaminase ( ALT and AST ) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN ( Gilbert's syndrome or liver metastasis subjects total bilirubin ≤ 2.5 × ULN ) ; renal function: serum creatinine clearance rate ≥ 60 mL/min ( calculated according to the Cockcroft-Gault formula ) ;
• ) voluntarily participated in and were able to undergo robot-assisted or thoracoscopic thymectomy, and complied with the study follow-up plan.

Критерии исключения

• ) Patients with myasthenia gravis crisis ;
• ) had undergone mediastinal surgery or cardiac surgery ;
• ) body mass index ( BMI ) ≥ 30 ;
• ) Patients with severe liver and kidney dysfunction ( ALT and/or AST more than three times the upper limit of normal, Cr more than the upper limit of normal ) ;
• ) combined with severe chronic lung diseases such as COPD, asthma, or interstitial lung disease ;
• ) suffering from uncontrolled heart, kidney, gastrointestinal, and infectious diseases and other complications ;
• ) patients with other malignant tumors or hematological diseases ;
• ) combined with chronic pain or preoperative use of opioid analgesics ;
• ) patients with thoracic deformity or combined with pectus carinatum and pectus excavatum ;
• ) have mental disorders, such as anxiety disorders ;
• ) pregnant and/or lactating women ;
• ) is currently participating in other interventional clinical studies.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Shanghai Pulmonary Hospital — Шанхай
• The Second Affiliated Hospital Zhejiang University School of Medicine — Zhejiang

Идентификаторы

NCT: NCT06029621 · STAR006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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