Single Port Robotic Lung Anatomical Resection

Pilot Study of Single Port Robotic Surgery for Anatomical Lung Resection

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

Study Overview

• Status: Active, not recruiting
• Conditions: Robotic Surgical Procedure
• Intervention / Treatment: Device: Lung Anatomic Resection (Da Vinci SP)

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yin Kai Chao, MD,PHD; Phone Number: +886975368205; Email: chaoyk@cgmh.org.tw
• Study Contact Backup: Name: Ching Feng Wu, MD; Phone Number: +886975366165; Email: maple.bt88@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Chang Gung Memeorial Hospital, Linkou Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day follow-up	Complications (assed according to CTCAE)	Post-operative data through 30-day follow-up
Questionnaire assessment (1)	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.	Through study completion, an average of 1 year
Questionnaire assessment (2)	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.	Through study completion, an average of 1 year
90-day follow up (1)	Complications (assed according to CTCAE)	Post-operative data through 90-day follow-up
Pathological Report	pathologic tumor staging, surgical margins	Post-operative data through 30-day follow-up
90-day Follow up (2)	Unplanned procedure-related reoperations or readmissions, mortality	Post-operative data through 90-day follow-up

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yin Kai Chao, MD,PHD, Cheng Gung memorial hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Estimated): May 5, 2024
• Study Completion (Estimated): May 5, 2024

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Early Stage Lung Cancer; Da Vinci SP; Robotic Thoracic Surgery
• Other Study ID Numbers: 202101423A0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No