Single Port Robotic Lung Anatomical Resection

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

Detailed Description
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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

Official Title
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Pilot Study of Single Port Robotic Surgery for Anatomical Lung Resection

Conditions
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Robotic Surgical Procedure

Intervention / Treatment
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* Device: Lung Anatomic Resection (Da Vinci SP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >20 and <75 years-old Willing and able to provide informed consent ASA≤ 3 The subject is undergoing the following procedures diagnosis with of clinical stage I lung cancer The primary tumor should be less than ≤4cm diameter and ≥ 2 cm away from the origin of the associated lobar bronchus Preoperative platelet count 150-400 (1000/ uL) Exclusion Criteria: Congestive heart failure (NHYA > II) Subjects with a known bleeding or clotting disorder Subjects actively receiving therapeutic dose anticoagulation or anti-platelet medications at the time of operation Subjects under immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgery Subjects with pulmonary hypertension In need of extended resection (e.g. Chest wall, Carina, major vessel, bilobectomy) and reconstruction (e.g. Sleeve resection, bronchoplasty, angioplasty) Previous ipsilateral thoracic surgery or sternotomy Uncontrolled illness 6 months prior to planned surgical procedure including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Previous neoadjuvant medical and/or radiation therapy Subject has a contraindication for general anesthesia or surgery Life expectancy < 6 months Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery Subjects belong to vulnerable population (e.g., pregnancy or breastfeeding) International normalized ratio, INR >1.4 Activated Partial Thromboplastin Time , APTT >35 -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: clinical lung cancer who receive Da Vinci sp robotic surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Da Vinci SP intervnetion group<br>for patients who received Da Vinci SP robotic surgery | Device: Lung Anatomic Resection (Da Vinci SP)<br>* To evaluate the performance and safety of the da Vinci SP® Surgical System in anatomical lung resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of conversion rate | 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. | During Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Related Adverse Events | 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. | One Year | 
| Peri-operative parameters | Operation time (minute), docking time (minute), console time(minute), anesthesia time(minute), Time from recovery room to ward (minute) | From Surgery to ward,2- day | 
| Peri-operative parameters: blood loss related | which include bloods loss(ml) during operation, blood transfusion (ml) during surgery | During surgery | 
| Hospitalization parameters | which include, length of hospital stay (day) | During Hospitalization, an average of 4 days | 
| Operative related complications during hospitalization | which include in-hospital mortality and morbidity, reasons need for reoperation, unplanned procedure after surgery | During Hospitalization, an average of 4 days | 
| Patient disposition immediately after surgery | ICU, ward | During Hospitalization, an average of 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Stage Lung Cancer, Da Vinci SP, Robotic Thoracic Surgery