Single Port Robotic Lung Anatomical Resection

Not Applicable

Active, not recruiting

• Conditions: Robotic Surgical Procedure
• Interventions: Device: Lung Anatomic Resection (Da Vinci SP)

• Registration Number: NCT05535712
• Lead Sponsor: Chang Gung Memorial Hospital

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

Study Timeline

• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-10
• Study Start: 2022-10-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-29
• Last Update Posted: 2023-10-31
• Primary Completion: 2024-05-05
• Study Completion: 2024-05-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Da Vinci SP intervnetion group	Lung Anatomic Resection (Da Vinci SP)	for patients who received Da Vinci SP robotic surgery

Primary Outcome Measures

Name	Time	Method
Incidence of conversion rate	During Surgery	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chang Gung Memeorial Hospital, Linkou Medical Center; 🇨🇳 Taoyuan, Taiwan