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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
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solitary Pulmonary Nodule

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 27, 2016
    Last Updated
    June 28, 2016
    Sponsor
    National Taiwan University Hospital
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    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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