Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Endpoints (Outcome measures):
Primary endpoint: Incidence of conversion rate during surgery
- The primary performance endpoint will be assessed as the ability to successfully complete the planned mediastinal procedure with da Vinci SP System, with no conversion to open surgery, video-assisted thoracoscopic surgery (VATS), multi-port robotic surgery or approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach. Use of additional assistant port(s) is not considered a conversion
Secondary endpoints: Incidence of treatment related adverse events - The safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow up period
During the past several years, minimally invasive thoracic surgery has evolved from thoracoscopic approaches using 3 -4 ports to a single incision video-assisted thoracoscopic surgery (VATS) techniques. Recently, the experience acquired with the uniportal VATS technique through the intercostal space has allowed the development of a uniportal VATS subxiphoid or subcostal approach for anterior mediastinal tumor resections. The advantage of using a subxiphoid or subcostal entry is to reduce pain by avoiding possible trauma of intercostal nerves caused by thoracic incisions. However, the longer distance from the subxiphoid or subcostal incision to the anterior mediastinal area makes this approach more difficult to perform extended thymothymectomy. During this same period of evolution into uniportal VATS surgery, robotic thoracic surgery has gained popularity as an alternative to traditional VATS. The advantages of robotics are the ability to perform surgery more precisely with articulated or wristed instruments, motion scaling, and tremor filtration, as well as improved visualization thanks to 3D high-definition video. However, currently 4 -5 incisions are still necessary to perform anatomic robotic resections.Recently, there has been a convergence of these two trends-uniportal surgery and robotic-assisted surgery-and has resulted in a single port robotic system, the da Vinci SP by Intuitive Surgical Cooperation. For this new platform, investigators plan to practice in extended thymothymectomy
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients with qualified criteria will be enrolled in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Da Vinci SP surgical platform | Device | using Da Vinci SP platform in thymothymectomy or extended thymectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of conversion rate | The primary performance endpoint will be assessed as the ability to successfully complete the planned procedure with da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery. | During Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | The safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow up period. Rceord the Incidence of Treatment-Emergent Adverse Events in our recording form | One year |
Not provided
Inclusion criteria
Age >20 and <75 years-old
Willing and able to provide informed consent
ASA≤ 3
The subject fulfills one or both of the following criteria:
Class I-IV Myasthenia gravis according to the Myasthenia Gravis Foundation of America Scientific Session (MGFA)
Exclusion criteria. Myasthenia gravis or thymoma patients with
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yin Kai Chao, MD,PHD | CHENG GUNG MEMORIAL HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memeorial Hospital, Linkou Medical Center | Taoyuan | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41923497 | Derived | Cheng C, Wen YW, Chien MS, Chao YK. Chronic Neuralgia After Single-Port Versus Multiport Trans-Subxiphoid Robotic Mediastinal Surgery: A Prospective Single-Arm Pilot Study With Historical Controls. Int J Med Robot. 2026 Apr;22(2):e70158. doi: 10.1002/rcs.70158. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013945 | Thymoma |
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
Not provided
Not provided
thymothmectomy or extended thymectomy through Da Vinci SP platform
Not provided
Not provided
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |