<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03230019</url>
  </required_header>
  <id_info>
    <org_study_id>TBL-1</org_study_id>
    <nct_id>NCT03230019</nct_id>
  </id_info>
  <brief_title>Two-Lumen Catheterization For Lung Wedge Resection</brief_title>
  <official_title>Two-Lumen Catheterization Versus Chest Tube Placement in Patients With Lung Wedge Resection: A Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wen-zhao ZHONG</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GuangdongPPH</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the viability and safety of two-lumen catheterization versus chest tube&#xD;
      placement in patients with lung wedge resection. Half of participants will receive routine&#xD;
      chest tube placement, while the other half will receive a two-lumen central venous&#xD;
      catheterization along the midclavicular line, second intercostal space for remedial&#xD;
      gas-remove.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the development of video-assisted thoracoscopic surgery (VATS) techniques, minimally&#xD;
      invasive thoracic surgery has evolved considerably over the last three decades. The concept&#xD;
      of &quot;tubeless&quot; involves non-intubated anesthesia with spontaneous ventilation and no chest&#xD;
      tube placement. Chest tube placement always causes pain, and its duration is known to be one&#xD;
      of the most important factors influencing hospital stay and costs. Early tube removal allows&#xD;
      patients to breathe deeply with less pain, which leads to more compliance with chest&#xD;
      physiotherapy, as demonstrated by a concomitant improvement in patients' ventilatory&#xD;
      function. Hence, more and more experienced surgeons choose the omission of chest tube&#xD;
      placement after lung wedge resection. However, based on previous retrospective studies,&#xD;
      residual pneumothorax was noted in about 10~40% cases, and some of them need re-intervention.&#xD;
      Hence, the investigators designed a intra-operative two-lumen catheterization for remedial&#xD;
      gas-remove. Therefore, this study evaluates the viability and safety of two-lumen&#xD;
      catheterization versus chest tube placement in patients with lung wedge resection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 25, 2017</start_date>
  <completion_date type="Anticipated">October 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative adverse event incidence rate</measure>
    <time_frame>1 months</time_frame>
    <description>To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray) or pleural effusion (&gt;800ml) in both groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of post-operative hospital stay</measure>
    <time_frame>1 week</time_frame>
    <description>To evaluate the length of post-operative hospital stay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of post-operative related complications</measure>
    <time_frame>1 week</time_frame>
    <description>To evaluate the rate of post-operative related complications within 7 days of surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pneumoderm incidence rate</measure>
    <time_frame>3 days</time_frame>
    <description>To evaluate the postoperative pneumoderm incidence rate in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time of post-operative extubation</measure>
    <time_frame>1 week</time_frame>
    <description>To evaluate the time of duration of chest tube or catheterization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pulmonary function recovery</measure>
    <time_frame>1 week</time_frame>
    <description>To evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain score</measure>
    <time_frame>1 day</time_frame>
    <description>To evaluate the pain score via NRS pain scale first day after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative wound satisfaction</measure>
    <time_frame>1 month</time_frame>
    <description>To evaluate the post-operative wound healing condition .</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Characteristics of plasma exosome for the solitary pulmonary nodules</measure>
    <time_frame>1 month</time_frame>
    <description>We prospectively collect the preoperative plasma sample of patients with solitary pulmonary nodule in this study to determine the diagnostic value and molecular characteristics of plasma exosome-derived miRNAs for these patients.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Thoracic Surgery, Video-Assisted</condition>
  <arm_group>
    <arm_group_label>chest tube</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VATS with chest tube placement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>two-lumen catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VATS with two-lumen catheterization</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>chest tube</intervention_name>
    <description>VATS with chest tube placement</description>
    <arm_group_label>chest tube</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>two-lumen catheterization</intervention_name>
    <description>VATS with two-lumen catheterization long the midclavicular line, second intercostal space</description>
    <arm_group_label>two-lumen catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>two-lumen catheter</intervention_name>
    <description>central venous catheter(two-lumen 7-Fr-20cm)</description>
    <arm_group_label>two-lumen catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Preoperative radiology revealed solitary peripheral pulmonary nodule, with both size&#xD;
             and depth less than 3 cm&#xD;
&#xD;
          2. Lung wedge resection for tumor biopsy to elucidate drug resistant mechanism or confirm&#xD;
             diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous ipsilateral thoracic surgery or extensive adhesion&#xD;
&#xD;
          2. Preoperative radiology revealed pneumonia or atelectasis&#xD;
&#xD;
          3. Any unstable systemic disease (including active infection, uncontrolled hypertension,&#xD;
             unstable angina, congestive heart failure, myocardial infarction within the previous&#xD;
             year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic&#xD;
             disease).&#xD;
&#xD;
          4. Bleeding tendency or anticoagulant use&#xD;
&#xD;
          5. Pregnancy or breast feeding&#xD;
&#xD;
          6. Patient who can not sign permit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen-Zhao Zhong, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Provincial People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wen-Zhao Zhong</last_name>
    <phone>18820792959</phone>
    <email>18820792959@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Song Dong</last_name>
    <phone>13631381979</phone>
    <email>dsong@aliyun.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>51000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wen-Zhao Zhong, Ph.D</last_name>
      <phone>13609777314</phone>
      <email>13609777314@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Song Dong, Ph.D</last_name>
      <phone>13631381979</phone>
      <email>dsong@aliyun.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Yang SM, Wang ML, Hung MH, Hsu HH, Cheng YJ, Chen JS. Tubeless Uniportal Thoracoscopic Wedge Resection for Peripheral Lung Nodules. Ann Thorac Surg. 2017 Feb;103(2):462-468. doi: 10.1016/j.athoracsur.2016.09.006. Epub 2016 Nov 16.</citation>
    <PMID>27865474</PMID>
  </reference>
  <reference>
    <citation>Watanabe A, Watanabe T, Ohsawa H, Mawatari T, Ichimiya Y, Takahashi N, Sato H, Abe T. Avoiding chest tube placement after video-assisted thoracoscopic wedge resection of the lung. Eur J Cardiothorac Surg. 2004 May;25(5):872-6. doi: 10.1016/j.ejcts.2004.01.041.</citation>
    <PMID>15082297</PMID>
  </reference>
  <reference>
    <citation>Ueda K, Hayashi M, Tanaka T, Hamano K. Omitting chest tube drainage after thoracoscopic major lung resection. Eur J Cardiothorac Surg. 2013 Aug;44(2):225-9; discussion 229. doi: 10.1093/ejcts/ezs679. Epub 2013 Jan 12.</citation>
    <PMID>23313864</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>November 10, 2018</last_update_submitted>
  <last_update_submitted_qc>November 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial People's Hospital</investigator_affiliation>
    <investigator_full_name>Wen-zhao ZHONG</investigator_full_name>
    <investigator_title>Guangdong General Hospital</investigator_title>
  </responsible_party>
  <keyword>wedge resection</keyword>
  <keyword>tubeless</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03230019
org study id: TBL-1
nct id: NCT03230019
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the viability and safety of two-lumen catheterization versus chest tube
      placement in patients with lung wedge resection. Half of participants will receive routine
      chest tube placement, while the other half will receive a two-lumen central venous
      catheterization along the midclavicular line, second intercostal space for remedial
      gas-remove.
With the development of video-assisted thoracoscopic surgery (VATS) techniques, minimally
      invasive thoracic surgery has evolved considerably over the last three decades. The concept
      of "tubeless" involves non-intubated anesthesia with spontaneous ventilation and no chest
      tube placement. Chest tube placement always causes pain, and its duration is known to be one
      of the most important factors influencing hospital stay and costs. Early tube removal allows
      patients to breathe deeply with less pain, which leads to more compliance with chest
      physiotherapy, as demonstrated by a concomitant improvement in patients' ventilatory
      function. Hence, more and more experienced surgeons choose the omission of chest tube
      placement after lung wedge resection. However, based on previous retrospective studies,
      residual pneumothorax was noted in about 10~40% cases, and some of them need re-intervention.
      Hence, the investigators designed a intra-operative two-lumen catheterization for remedial
      gas-remove. Therefore, this study evaluates the viability and safety of two-lumen
      catheterization versus chest tube placement in patients with lung wedge resection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative adverse event incidence rate
time frame: 1 months
description: To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray) or pleural effusion (>800ml) in both groups.
measure: Length of post-operative hospital stay
time frame: 1 week
description: To evaluate the length of post-operative hospital stay
measure: Rate of post-operative related complications
time frame: 1 week
description: To evaluate the rate of post-operative related complications within 7 days of surgery
measure: Postoperative pneumoderm incidence rate
time frame: 3 days
description: To evaluate the postoperative pneumoderm incidence rate in both groups.
measure: The time of post-operative extubation
time frame: 1 week
description: To evaluate the time of duration of chest tube or catheterization.
measure: Postoperative pulmonary function recovery
time frame: 1 week
description: To evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.
measure: Postoperative pain score
time frame: 1 day
description: To evaluate the pain score via NRS pain scale first day after surgery.
measure: Postoperative wound satisfaction
time frame: 1 month
description: To evaluate the post-operative wound healing condition .
measure: Characteristics of plasma exosome for the solitary pulmonary nodules
time frame: 1 month
description: We prospectively collect the preoperative plasma sample of patients with solitary pulmonary nodule in this study to determine the diagnostic value and molecular characteristics of plasma exosome-derived miRNAs for these patients.
arm group label: chest tube
arm group type: Active Comparator
description: VATS with chest tube placement
arm group label: two-lumen catheter
arm group type: Experimental
description: VATS with two-lumen catheterization
intervention type: Procedure
intervention name: chest tube
description: VATS with chest tube placement
arm group label: chest tube
intervention type: Procedure
intervention name: two-lumen catheterization
description: VATS with two-lumen catheterization long the midclavicular line, second intercostal space
arm group label: two-lumen catheter
intervention type: Device
intervention name: two-lumen catheter
description: central venous catheter(two-lumen 7-Fr-20cm)
arm group label: two-lumen catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wen-Zhao Zhong, Ph.D
role: Principal Investigator
affiliation: Guangdong Provincial People's Hospital
last name: Wen-Zhao Zhong
phone: 18820792959
email: 18820792959@163.com
last name: Song Dong
phone: 13631381979
email: dsong@aliyun.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Yang SM, Wang ML, Hung MH, Hsu HH, Cheng YJ, Chen JS. Tubeless Uniportal Thoracoscopic Wedge Resection for Peripheral Lung Nodules. Ann Thorac Surg. 2017 Feb;103(2):462-468. doi: 10.1016/j.athoracsur.2016.09.006. Epub 2016 Nov 16.
PMID: 27865474
citation: Watanabe A, Watanabe T, Ohsawa H, Mawatari T, Ichimiya Y, Takahashi N, Sato H, Abe T. Avoiding chest tube placement after video-assisted thoracoscopic wedge resection of the lung. Eur J Cardiothorac Surg. 2004 May;25(5):872-6. doi: 10.1016/j.ejcts.2004.01.041.
PMID: 15082297
citation: Ueda K, Hayashi M, Tanaka T, Hamano K. Omitting chest tube drainage after thoracoscopic major lung resection. Eur J Cardiothorac Surg. 2013 Aug;44(2):225-9; discussion 229. doi: 10.1093/ejcts/ezs679. Epub 2013 Jan 12.
PMID: 23313864
responsible party type: Sponsor-Investigator
investigator affiliation: Guangdong Provincial People's Hospital
investigator full name: Wen-zhao ZHONG
investigator title: Guangdong General Hospital
sharing ipd: No