Single Port Robotic Lung Anatomical Resection

NCT ID: NCT05535712

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-07
• Study Completion Date: 2024-05-05

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

Conditions

Robotic Surgical Procedure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Da Vinci SP intervnetion group

for patients who received Da Vinci SP robotic surgery

Group Type: EXPERIMENTAL

Lung Anatomic Resection (Da Vinci SP)

Intervention Type: DEVICE

To evaluate the performance and safety of the da Vinci SP® Surgical System in anatomical lung resection

Interventions

Lung Anatomic Resection (Da Vinci SP)

To evaluate the performance and safety of the da Vinci SP® Surgical System in anatomical lung resection

Intervention Type: DEVICE

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 -

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yin Kai Chao, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

CHENG GUNG MEMORIAL HOSPITAL

Locations

Chang Gung Memeorial Hospital, Linkou Medical Center

Taoyuan District, , Taiwan

Countries

Taiwan

References

Cheng C, Tagkalos E, Ng CB, Hsu YC, Huang YY, Wu CF, Chao YK. Subcostal uniportal robotic anatomic lung resection: A pilot trial. JTCVS Tech. 2024 Apr 28;25:160-169. doi: 10.1016/j.xjtc.2024.01.024. eCollection 2024 Jun.

Reference Type: DERIVED

PMID: 38899114 (View on PubMed)

Other Identifiers

202101423A0

Identifier Type: -

Identifier Source: org_study_id