Clinical trial NCT05535712: Single Port Robotic Lung Anatomical Resection
Official title: Pilot Study of Single Port Robotic Surgery for Anatomical Lung Resection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Robotic Surgical Procedure
Keywords: Early Stage Lung Cancer
Da Vinci SP
Robotic Thoracic Surgery
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: clinical lung cancer who receive Da Vinci sp robotic surgery
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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 -

Primary outcomes:
measure: Incidence of conversion rate
timeFrame: During Surgery
Secondary outcomes:
measure: Incidence of Treatment Related Adverse Events
timeFrame: One Year
measure: Peri-operative parameters
timeFrame: From Surgery to ward,2- day
measure: Peri-operative parameters: blood loss related
timeFrame: During surgery
measure: Hospitalization parameters
timeFrame: During Hospitalization, an average of 4 days
measure: Operative related complications during hospitalization
timeFrame: During Hospitalization, an average of 4 days
measure: Patient disposition immediately after surgery
timeFrame: During Hospitalization, an average of 1 day
Other outcomes:
measure: 30-day follow-up
timeFrame: Post-operative data through 30-day follow-up
measure: Questionnaire assessment (1)
timeFrame: Through study completion, an average of 1 year
measure: Questionnaire assessment (2)
timeFrame: Through study completion, an average of 1 year
measure: 90-day follow up (1)
timeFrame: Post-operative data through 90-day follow-up
measure: Pathological Report
timeFrame: Post-operative data through 30-day follow-up
measure: 90-day Follow up (2)
timeFrame: Post-operative data through 90-day follow-up
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memeorial Hospital, Linkou Medical Center
Study officials:
affiliation: CHENG GUNG MEMORIAL HOSPITAL
name: Yin Kai Chao, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: