Tubeless VATS for Peripheral Lung Nodule

NCT ID: NCT02817048

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-09-30

Brief 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.

Detailed 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.

Conditions

Solitary Pulmonary Nodule

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tubeless

Interventions: VATS without chest tube placement

Group Type: ACTIVE_COMPARATOR

VATS without chest tube placement

Intervention Type: PROCEDURE

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

Chest tube

VATS with chest tube placement

Group Type: ACTIVE_COMPARATOR

chest tube

Intervention Type: DEVICE

VATS with chest tube placement

Intervention Type: PROCEDURE

Interventions

chest tube

Intervention Type: DEVICE

VATS without chest tube placement

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

Intervention Type: PROCEDURE

VATS with chest tube placement

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin-Shing Chen, MD, PhD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Central Contacts

Jin-Shing Chen, MD, PhD

Role: CONTACT

chenjs@ntu.edu.tw

886-2-23123456 ext. 65178

References

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. doi: 10.1016/j.athoracsur.2004.05.083.

Reference Type: RESULT

PMID: 15511470 (View on PubMed)

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. 2010 May;89(5):1625-7. doi: 10.1016/j.athoracsur.2010.01.087.

Reference Type: RESULT

PMID: 20417792 (View on PubMed)

Other Identifiers

201603030RIND

Identifier Type: -

Identifier Source: org_study_id