Tubeless VATS for Peripheral Lung Nodule

Solitary Pulmonary Nodule Clinical Trial

Official title:

Thoracoscopic Surgery Without Chest Tube Placement in Patients With Peripheral Lung Nodules: A Prospective Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02817048
• Other study ID #: 201603030RIND
• Status: Not yet recruiting
• Phase: N/A
• First received: June 27, 2016
• Last updated: June 28, 2016
• Start date: June 2016
• Est. completion date: September 2017

Study information

• Verified date: June 2016
• Source: National Taiwan University Hospital
• Contact: Jin-Shing Chen, MD, PhD
• Phone: 886-2-23123456
• Email: chenjs[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Chest tube placement after thoracoscopy surgery had been generally accepted as routine procedure for removal of the residual intrapleural fluid and air, however, it would cause post-operative pain, prohibit ambulation after surgery, and prolong the hospital stay. According to the recent studies, omission of chest tube placement after minor thoracoscopic procedures (such as pulmonary wedge resection) had been safe and feasible, and it also reduced the post-operative pain and shortened the hospital stay. We will conduct a prospective randomized trial in National Taiwan University Hospital.

Description:

We will enroll 100 patients with peripheral lung nodule who will be randomly assigned to no chest tube placement (tubeless group) or chest tube placement (control group) after thoracoscopic wedge resection with out without lymph adenectomy. The primary endpoints are to compare the post-operative hospital stay and post-operative pain sale between the two groups. The secondary endpoints are to compare the intercostal neuralgia and wound satisfaction one month after surgery between the two groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• CT revealed peripheral lung nodule, with both size and depth less than 2 cm

• Aged 20 to 80 years

Exclusion Criteria:

• Patients with ventilatory defect

• Previous ipsilateral thoracic surgery

• Bleeding tendency or anticoagulant use

• Comorbidity including congestive heart failure, liver cirrhosis, chronic renal disease

• Pregnancy or breast feeding

• Immunocompromised or long-term steroid use

• Severe infected patient

• Patient who can not sign permit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule

Intervention

Device:
• chest tube

Procedure:
• VATS without chest tube placement
Patient received Video-Assisted Thoracic Surgery (VATS) wedge resection for peripheral lung nodule without chest tube placement (Tubeless)
• VATS with chest tube placement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

References & Publications (2)

Pompeo E, Mineo D, Rogliani P, Sabato AF, Mineo TC. Feasibility and results of awake thoracoscopic resection of solitary pulmonary nodules. Ann Thorac Surg. 2004 Nov;78(5):1761-8. — View Citation

Rocco G, Romano V, Accardo R, Tempesta A, La Manna C, La Rocca A, Martucci N, D' Aiuto M, Polimeno E. Awake single-access (uniportal) video-assisted thoracoscopic surgery for peripheral pulmonary nodules in a complete ambulatory setting. Ann Thorac Surg. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital cost		1 week	No
Primary	Postoperative hospital stay		1 week	No
Secondary	Postoperative pain score		1 week	No
Secondary	Postoperative intercostal neuralgia		1 month	No
Secondary	Postoperative wound satisfaction		1 month	No