Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

for patients who received Da Vinci SP robotic surgery

To evaluate the performance and safety of the da Vinci SP® Surgical System in anatomical lung resection

Lung Anatomic Resection (Da Vinci SP)

Yin Kai Chao, MD,PHD

This is the first human clinical study for explore the feasibility of lung anatomic resection through Da Vinci SP surgical platform

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 major pulmonary 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 hilum makes this approach more difficult to perform anatomical pulmonary resections.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 thoracic anatomic lung resection

clinical lung cancer who receive Da Vinci sp robotic surgery

Single Port Robotic Lung Anatomical Resection

Pilot Study of Single Port Robotic Surgery for Anatomical Lung Resection

Enrolled subjects would be assessed by pain scale score at baseline (preoperatively), during inpatient phase.

Neuropathic pain assessment (Assessment of post-VATS surgery neuralgia- pain DETECT Questionnaire), performed during inpatient phase (Post-operation 1 day, 2 days and day of discharge) and 1 week, 1,3,6,12 months after discharge.

Enrolled subjects would be assessed by numbness score at baseline (preoperatively), during inpatient phase.

Neuropathic pain assessment (Assessment of post-VATS surgery neuralgia- pain DETECT Questionnaire), performed during inpatient phase (Post-operation 1 day, 2 days and day of discharge) and 1 week, 1,3,6,12 months after discharge.

pathologic tumor staging, surgical margins

Unplanned procedure-related reoperations or readmissions, mortality

The primary performance endpoint will be assessed as the ability to successfully complete the planned anatomic resection procedure with the da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery. Usage of additional assistant port(s) is not considered a conversion.

The primary safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur within the study follow-up period. Complications are assessed using the Common Terminology Criteria for Adverse Events, CTCAE.

Operation time (minute), docking time (minute), console time(minute), anesthesia time(minute), Time from recovery room to ward (minute)

which include bloods loss(ml) during operation, blood transfusion (ml) during surgery

which include, length of hospital stay (day)

which include in-hospital mortality and morbidity, reasons need for reoperation, unplanned procedure after surgery

Chang Gung Memorial Hospital

Nervous System Diseases

Immune System Diseases

Wounds and Injuries

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Myasthenia Gravis

Surgical Wound

Mediastinal Neoplasms

Thymoma

Thymus Neoplasms

Mediastinal Diseases

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Thoracic Diseases

Respiratory Tract Diseases

Patients with qualified criteria will be enrolled in this study

using Da Vinci SP platform in thymothymectomy or extended thymectomy

Da Vinci SP surgical platform

Endpoints (Outcome measures)：

1. 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
2. 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

thymothmectomy or extended thymectomy through Da Vinci SP platform

A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Anterior Mediastinal Disease

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single Port Robotic Lung Anatomical Resection	NCT05535712	Robotic Surgica...	Lung Anatomic R...	20 Years - 75 Years	Chang Gung Memorial Hospital
A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Anterior Mediastinal Disease	NCT05455840	Robotic Surgica... Thymoma Myasthenia Grav...	Da Vinci SP sur...	20 Years - 75 Years	Chang Gung Memorial Hospital
A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Anterior Mediastinal Disease	NCT05455840	Robotic Surgica... Thymoma Myasthenia Grav...	Da Vinci SP sur...	20 Years - 75 Years	Chang Gung Memorial Hospital

Spots Global Cancer Trial Database for robotic surgical procedure