Tubeless VATS for Peripheral Lung Nodule
Primary Purpose
Solitary Pulmonary Nodule
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
chest tube
VATS without chest tube placement
VATS with chest tube placement
Sponsored by
About this trial
This is an interventional treatment trial for Solitary Pulmonary Nodule
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tubeless
Chest tube
Arm Description
Interventions: VATS without chest tube placement
VATS with chest tube placement
Outcomes
Primary Outcome Measures
Postoperative hospital stay
Secondary Outcome Measures
Postoperative pain score
Postoperative intercostal neuralgia
Postoperative wound satisfaction
Full Information
NCT ID
NCT02817048
First Posted
June 27, 2016
Last Updated
June 28, 2016
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02817048
Brief Title
Tubeless VATS for Peripheral Lung Nodule
Official Title
Thoracoscopic Surgery Without Chest Tube Placement in Patients With Peripheral Lung Nodules: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Pulmonary Nodule
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tubeless
Arm Type
Active Comparator
Arm Description
Interventions: VATS without chest tube placement
Arm Title
Chest tube
Arm Type
Active Comparator
Arm Description
VATS with chest tube placement
Intervention Type
Device
Intervention Name(s)
chest tube
Intervention Type
Procedure
Intervention Name(s)
VATS without chest tube placement
Intervention Description
Patient received Video-Assisted Thoracic Surgery (VATS) wedge resection for peripheral lung nodule without chest tube placement (Tubeless)
Intervention Type
Procedure
Intervention Name(s)
VATS with chest tube placement
Primary Outcome Measure Information:
Title
Postoperative hospital stay
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Postoperative pain score
Time Frame
1 week
Title
Postoperative intercostal neuralgia
Time Frame
1 month
Title
Postoperative wound satisfaction
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Hospital cost
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Shing Chen, MD, PhD
Phone
886-2-23123456
Ext
65178
Email
chenjs@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
15511470
Citation
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.
Results Reference
result
PubMed Identifier
20417792
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. 2010 May;89(5):1625-7. doi: 10.1016/j.athoracsur.2010.01.087.
Results Reference
result
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Tubeless VATS for Peripheral Lung Nodule
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