Single Port Robotic Lung Anatomical Resection

Chang Gung Medical Foundation

Status: Active, not recruiting

Conditions: Robotic Surgical Procedure

Treatments: Device: Lung Anatomic Resection (Da Vinci SP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05535712

202101423A0

Details and patient eligibility

About

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

Full description

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

Enrollment: 35 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >20 and <75 years-old

2. Willing and able to provide informed consent

3. ASA≤ 3

4. The subject is undergoing the following procedures

   1. diagnosis with of clinical stage I lung cancer
   2. The primary tumor should be less than ≤4cm diameter and ≥ 2 cm away from the origin of the associated lobar bronchus

5. Preoperative platelet count 150-400 (1000/ uL)

Exclusion criteria

1. Congestive heart failure (NHYA > II)
2. Subjects with a known bleeding or clotting disorder
3. Subjects actively receiving therapeutic dose anticoagulation or anti-platelet medications at the time of operation
4. Subjects under immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgery
5. Subjects with pulmonary hypertension
6. In need of extended resection (e.g. Chest wall, Carina, major vessel, bilobectomy) and reconstruction (e.g. Sleeve resection, bronchoplasty, angioplasty)
7. Previous ipsilateral thoracic surgery or sternotomy
8. 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
9. Previous neoadjuvant medical and/or radiation therapy
10. Subject has a contraindication for general anesthesia or surgery
11. Life expectancy < 6 months
12. Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
13. Subjects belong to vulnerable population (e.g., pregnancy or breastfeeding)
14. International normalized ratio, INR >1.4
15. Activated Partial Thromboplastin Time , APTT >35 -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Da Vinci SP intervnetion group

Experimental group

Description:

for patients who received Da Vinci SP robotic surgery

Treatment:

Device: Lung Anatomic Resection (Da Vinci SP)