<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/NCT04461652</url>
  </required_header>
  <id_info>
    <org_study_id>TongiU</org_study_id>
    <nct_id>NCT04461652</nct_id>
  </id_info>
  <brief_title>The Effect of a Combined Drainage Strategy in Uniportal Upper Lung Lobectomy</brief_title>
  <official_title>The Drainage Effect of a Chest Tube Plus Prophylactic Air-extraction Catheter vs Traditional Drainage Strategy in Uniportal Upper Lung Lobectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traditional drainage for uniportal video assisted thoracoscopic surgery (VATS) is a routine&#xD;
      method, usually with one or two chest tubes at intercostal incisions, but postoperative pain&#xD;
      due to the chest tube and unsatisfied drainage effect was noted.&#xD;
&#xD;
      In this study, the investigators are going to explore whether a prophylactic air-extraction&#xD;
      catheter combined with chest tube drainage may not increase complications in uniportal VATS&#xD;
      for upper lung lobectomy. The patients would be assigned to two arms, one with a prophylactic&#xD;
      air-extraction catheter combined with chest tube, and another with two chest tubes, and the&#xD;
      effect of the combined drainage strategy will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research purpose and background:&#xD;
&#xD;
      Surgical resection is still one of the most important treatment methods for early stage&#xD;
      non-small cell lung cancer. Complete resection and reasonable dissection of mediastinal lymph&#xD;
      nodes are the key of cancer cure. Lobectomy has always been the standard surgical method for&#xD;
      lung cancer radical resection. It can remove the lesion and retain normal lung function by&#xD;
      resecting the lung lobe where the lesion is and preserve the remaining lobe. In recent years,&#xD;
      the development of uniport video-assisted thoracic surgery (VATS) has further reduced the&#xD;
      trauma, with treatment benefit similar with that of two-port and three-port thoracoscopy.&#xD;
      However, based on the single hole thoracoscopic lung recruitment, incision drainage and other&#xD;
      issues also need further evidence support.&#xD;
&#xD;
      No tube technology, such as no tracheal intubation, drainage tube, nor catheter combined with&#xD;
      video-assisted thoracoscopy, can significantly improve the rehabilitation of patients, and&#xD;
      further shorten the postoperative hospital stay. In addition, the safety of tubeless drainage&#xD;
      has been supported by more and more studies. However, poor drainage may also increase the&#xD;
      incidence of pneumothorax and postoperative pulmonary dysfunction.&#xD;
&#xD;
      After upper lobe lobectomy, the cavity needs to be filled by the full recruitment of the&#xD;
      remaining lobes. theoretically, there is a higher demand for the strategy of the drainage&#xD;
      tube. The investigatorstried to compare the safety and effectiveness of the prophylactic&#xD;
      air-extraction catheter (later known as microtubule) combined with thoracic tube drainage&#xD;
      with traditional double drainage tube alone. Therefore, the investigators conducted a&#xD;
      prospective, randomized, non inferiority trial to verify the hypothesis that microtubule&#xD;
      combined with thoracic catheter drainage after uniport VATS upper lobectomy will not increase&#xD;
      the related perioperative complications compared with traditional thoracic tube drainage.&#xD;
&#xD;
      Quality assurance plan:&#xD;
&#xD;
        1. The doctors participating in the operation and catheterization in clinical trials should&#xD;
           be at least attendings, so as to ensure the safety of operation and chest tube&#xD;
           placement.&#xD;
&#xD;
        2. The chest tube placement was carried out randomly with two arms.&#xD;
&#xD;
        3. From our previous clinical experience, the tube is placed for 3 days to 2 weeks, so it&#xD;
           last for a short time, and all of them can be extubated by doctors above the attending&#xD;
           level, so the detachment rate of the experiment is low and the quality can be&#xD;
           guaranteed.&#xD;
&#xD;
        4. The trial team has written the test related procedures into the team medical process,&#xD;
           including but not limited to the time point of chest X-ray.&#xD;
&#xD;
      Data checks:&#xD;
&#xD;
      Data checks will be performed by a individual attending doctor with GCP to compare data&#xD;
      entered into the registry against predefined rules for range or consistency with other data&#xD;
      fields in the registry.&#xD;
&#xD;
      Source data verification:&#xD;
&#xD;
      Source data verification will be performed by a individual attending doctor with GCP to&#xD;
      assess the accuracy, completeness, or representativeness of registry data by comparing the&#xD;
      data to external data sources (for example, medical records, paper or electronic case report&#xD;
      forms, or interactive voice response systems).&#xD;
&#xD;
      Data dictionary:&#xD;
&#xD;
      video assisted thoracoscopic surgery, VATS prophylactic air-extraction catheter, PAEC&#xD;
      Randomized clinical trial, RCT Non small cell lung cancer, NSCLC&#xD;
&#xD;
      Standard Operating Procedures:&#xD;
&#xD;
      Patients recruitment The subjects were recruited on a voluntary basis. If they decide to&#xD;
      participate in this study, the personal data of subjects participating in the trial are&#xD;
      confidential. The subject's blood samples will be identified by the study number, not the&#xD;
      subject's name. Information that identifies the subject will not be disclosed to members&#xD;
      outside the study team unless permission is obtained from the subject. All study members and&#xD;
      study sponsors were asked to keep their identities confidential. The subjects' files will be&#xD;
      kept in a locked file cabinet for researchers' reference only. In order to ensure that the&#xD;
      study is carried out in accordance with the regulations, members of the government&#xD;
      administration or the ethics review committee may access the subject's personal data in the&#xD;
      research unit as required. At the time of publication, no personal information will be&#xD;
      disclosed.&#xD;
&#xD;
      data collection All the patients learned about the two kinds of operation through&#xD;
      preoperative education, and voluntarily joined the research group and signed the ethical&#xD;
      agreement. In this clinical trial, patients were enrolled in the randomized controlled trial.&#xD;
      The members of the experimental group were only responsible for the inclusion and exclusion&#xD;
      of patients. The surgeons and assistants did not participate in the preoperative evaluation&#xD;
      and postoperative management. The pain assessment team, postoperative management personnel&#xD;
      and follow-up evaluators did not know what group the patients belonged to (patients could&#xD;
      wear wide clothes to cover the drainage tube after operation)&#xD;
&#xD;
      change management In cases with serious medical risk caused by the operation technology of&#xD;
      the trial, or the research indicates that the difference between the groups is too obvious,&#xD;
      the researcher should stop the trial and fill in the report form of violation of protocol&#xD;
      deviation and report to the ethics committee.&#xD;
&#xD;
      If the patients were enrolled normally and reached the number of cases required for the&#xD;
      trial, the trial was finished.&#xD;
&#xD;
      reporting for adverse events&#xD;
&#xD;
        1. The sponsor shall provide the safety research data of the technology and other safety&#xD;
           related information.&#xD;
&#xD;
        2. In the design scheme, the definition of adverse events should be clearly defined, and&#xD;
           the criteria for judging the severity of adverse events, as well as the classification&#xD;
           criteria for judging the relationship between adverse events and experimental operation&#xD;
           (such as positively related, possibly related, possibly unrelated, irrelevant and unable&#xD;
           to be determined). The protocol requires researchers to truthfully fill in the adverse&#xD;
           event record form, recording the occurrence time, severity, duration, measures taken and&#xD;
           outcome.&#xD;
&#xD;
        3. Before starting the trial, the members of the research team must be familiar with the&#xD;
           contents of the prevention and treatment of subjects and emergency plans in medical&#xD;
           treatment.&#xD;
&#xD;
        4. In case of SAE, the research physician must report to the project leader, the food and&#xD;
           drug administration, the sponsor, the medical ethics committee of our hospital, the&#xD;
           center ethics, and the office of drug clinical trial institution within 24 hours. When&#xD;
           and by what means (e.g. telephone, fax or written) to whom SAE was reported should be&#xD;
           recorded in the original data.&#xD;
&#xD;
        5. The original medical ethics committee reports the paper version, including the receipt&#xD;
           page (with PI signature), SAE form and processing process in triplicate, and then&#xD;
           reports the electronic version of PPT, which is then sent to wangxing5447@126.com&#xD;
&#xD;
        6. To study the doctor according to the implementation of treatment, if necessary, start to&#xD;
           prevent and deal with medical subjects and emergency plans.&#xD;
&#xD;
        7. At the same time, the research doctor should make a record of SAE, including at least&#xD;
           the description of adverse events, occurrence time, termination time, degree and&#xD;
           frequency of seizures, and the treatment given.&#xD;
&#xD;
        8. The medical ethics committee will hold a meeting to organize experts to report and&#xD;
           discuss the SAE and the treatment process in our hospital, and require the follow-up of&#xD;
           SAE.&#xD;
&#xD;
      Sample size assessment&#xD;
&#xD;
      The purpose of this study was to verify whether the new strategy is not inferior to&#xD;
      traditional method in uniport VATS upper lobe lobectomy. In terms of the incidence of&#xD;
      pneumothorax (primary), based on previous observational studies, the probability of&#xD;
      postoperative pneumothorax in new method and traditional method was about 10% and 6%.&#xD;
      Considering 25% of non-inferiority margin, efficacy analysis estimated that 75 patients in&#xD;
      each group were required to achieve power of 0.99 (via version 15.0; NCSs, Kaysville, UT,&#xD;
      USA) with unilateral α of 0.025. Considering some out of groups due to clinical factors or&#xD;
      other criteria (e.g., changing surgical methods according to pathological results during&#xD;
      operation, combined with other lobectomy, etc.), a total of 75 subjects in each group were&#xD;
      required, and 400 is the anticipating case number.&#xD;
&#xD;
      Plan for missing data The investigators made a plan for missing data to address situations&#xD;
      where variables are reported as missing, unavailable, non-reported, uninterpretable, or&#xD;
      considered missing because of data inconsistency or out-of-range results.&#xD;
&#xD;
      First, sufficient case is planned for the missing data generated from changes in surgery, as&#xD;
      combined lobectomy or sublobectomies. Second, all the surgeons in our department will be&#xD;
      informed of this study, and the changes in surgical method should be avoided to their best&#xD;
      effort.&#xD;
&#xD;
      Statistical analysis plan&#xD;
&#xD;
      Statistical analysis will be performed to these select two groups in terms of clinical&#xD;
      parameters, including the incidence of pneumothorax, reintubation rate, pain score and other&#xD;
      parameters, respectively using t test, chi square test, rank sum test and other means. SPSS&#xD;
      20 will be validated to compare the primary and secondary observation end points between the&#xD;
      two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 5, 2020</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2021</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>
    <intervention_model_description>The study is a prospective, randomized, non-inferiority trial, two different drainage strategy will be performed, and both were used routinely in clinical practice. One should be one thoracic tube (28fr drainage tube) was inserted through intercostal incision, and one microtubule (7fr × 20cm) was punctured through the middle line of clavicle, and another will be two conventional chest tubes (28fr or 24fr) were placed through intercostal incision.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Data collected from the X-rays and the pain score evaluation will be masked and the outcomes assessor have no method to get randomized information.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>pneumothorax incidence</measure>
    <time_frame>24-30 hours after surgery</time_frame>
    <description>The incidence of pneumothorax on day 1 after operation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain scores</measure>
    <time_frame>1day, 3days and 30 days after surgery</time_frame>
    <description>pain scores collected after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extubation time</measure>
    <time_frame>within 30 days after surgery</time_frame>
    <description>Extubation time after operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total volume</measure>
    <time_frame>1 day after surgery</time_frame>
    <description>Total volume of pleural effusion on the first day after operation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>New method</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One thoracic tube (28fr drainage tube) was inserted through intercostal incision, and one microtubule (7fr × 20cm) was punctured through the middle line of clavicle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional method</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two conventional chest tubes (28fr or 24fr) were placed through intercostal incision</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>prophylactic air-extraction catheter drainage</intervention_name>
    <description>This is a kind of venous catheter commonly used in clinic. It may bring less pain after being inserted into the chest, with an equivalent drainage effect with traditional thick drainage tube from our experience, especially in the aspect of gas drainage effect.</description>
    <arm_group_label>New method</arm_group_label>
    <arm_group_label>Traditional method</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing uniport VATS for left / right upper lobectomy in Shanghai&#xD;
             Pulmonary Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  preoperative presence of any unstable systemic disease, such as active infection,&#xD;
             uncontrolled hypertension, or unstable angina pectoris;&#xD;
&#xD;
          -  previous ipsilateral thoracic surgery;&#xD;
&#xD;
          -  preoperative X-ray findings of pneumonia or atelectasis;&#xD;
&#xD;
          -  bleeding tendency;&#xD;
&#xD;
          -  anticoagulant use;&#xD;
&#xD;
          -  pregnancy or breastfeeding;&#xD;
&#xD;
          -  converted to open chest;&#xD;
&#xD;
          -  the patient underwent pneumonectomy or segmental resection or wedge resection;&#xD;
&#xD;
          -  severe adhesion occurred during the operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tao Gui, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Tongji University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xing Wang, MD</last_name>
    <phone>+8615901013210</phone>
    <email>wangxing5447@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jiang Fan, MD</last_name>
    <phone>+86-21-65115006</phone>
    <email>fan_jiang@tongji.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Pulmonary Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiang Fan, MD</last_name>
      <phone>+86 13764271861</phone>
      <email>drjiangfan@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Jiang Fan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nan Song, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wenxin He, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Liang Duan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tao Ge, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hao Li, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Mun M, Nakao M, Matsuura Y, Ichinose J, Nakagawa K, Okumura S. Video-assisted thoracoscopic surgery lobectomy for non-small cell lung cancer. Gen Thorac Cardiovasc Surg. 2018 Nov;66(11):626-631. doi: 10.1007/s11748-018-0979-x. Epub 2018 Jul 30.</citation>
    <PMID>30062622</PMID>
  </results_reference>
  <results_reference>
    <citation>Bulgarelli Maqueda L, Garcia-Perez A, Minasyan A, Gonzalez-Rivas D. Uniportal VATS for non-small cell lung cancer. Gen Thorac Cardiovasc Surg. 2020 Jul;68(7):707-715. doi: 10.1007/s11748-019-01221-4. Epub 2019 Oct 15.</citation>
    <PMID>31617147</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang JT, Dong S, Chu XP, Lin SM, Yu RY, Jiang BY, Liao RQ, Nie Q, Yan HH, Yang XN, Wu YL, Zhong WZ. Randomized Trial of an Improved Drainage Strategy Versus Routine Chest Tube After Lung Wedge Resection. Ann Thorac Surg. 2020 Apr;109(4):1040-1046. doi: 10.1016/j.athoracsur.2019.11.029. Epub 2020 Jan 8.</citation>
    <PMID>31926158</PMID>
  </results_reference>
  <results_reference>
    <citation>Liu CY, Hsu PK, Leong KI, Ting CK, Tsou MY. Is tubeless uniportal video-assisted thoracic surgery for pulmonary wedge resection a safe procedure? Eur J Cardiothorac Surg. 2020 Aug 1;58(Suppl_1):i70-i76. doi: 10.1093/ejcts/ezaa061.</citation>
    <PMID>32182334</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji University</investigator_affiliation>
    <investigator_full_name>Jiang Fan</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Non-Small-Cell Lung Cancer</keyword>
  <keyword>video-assisted thoracic surgery</keyword>
  <keyword>drainage tube</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <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/NCT04461652
org study id: TongiU
nct id: NCT04461652
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Traditional drainage for uniportal video assisted thoracoscopic surgery (VATS) is a routine
      method, usually with one or two chest tubes at intercostal incisions, but postoperative pain
      due to the chest tube and unsatisfied drainage effect was noted.

      In this study, the investigators are going to explore whether a prophylactic air-extraction
      catheter combined with chest tube drainage may not increase complications in uniportal VATS
      for upper lung lobectomy. The patients would be assigned to two arms, one with a prophylactic
      air-extraction catheter combined with chest tube, and another with two chest tubes, and the
      effect of the combined drainage strategy will be evaluated.
Research purpose and background:

      Surgical resection is still one of the most important treatment methods for early stage
      non-small cell lung cancer. Complete resection and reasonable dissection of mediastinal lymph
      nodes are the key of cancer cure. Lobectomy has always been the standard surgical method for
      lung cancer radical resection. It can remove the lesion and retain normal lung function by
      resecting the lung lobe where the lesion is and preserve the remaining lobe. In recent years,
      the development of uniport video-assisted thoracic surgery (VATS) has further reduced the
      trauma, with treatment benefit similar with that of two-port and three-port thoracoscopy.
      However, based on the single hole thoracoscopic lung recruitment, incision drainage and other
      issues also need further evidence support.

      No tube technology, such as no tracheal intubation, drainage tube, nor catheter combined with
      video-assisted thoracoscopy, can significantly improve the rehabilitation of patients, and
      further shorten the postoperative hospital stay. In addition, the safety of tubeless drainage
      has been supported by more and more studies. However, poor drainage may also increase the
      incidence of pneumothorax and postoperative pulmonary dysfunction.

      After upper lobe lobectomy, the cavity needs to be filled by the full recruitment of the
      remaining lobes. theoretically, there is a higher demand for the strategy of the drainage
      tube. The investigatorstried to compare the safety and effectiveness of the prophylactic
      air-extraction catheter (later known as microtubule) combined with thoracic tube drainage
      with traditional double drainage tube alone. Therefore, the investigators conducted a
      prospective, randomized, non inferiority trial to verify the hypothesis that microtubule
      combined with thoracic catheter drainage after uniport VATS upper lobectomy will not increase
      the related perioperative complications compared with traditional thoracic tube drainage.

      Quality assurance plan:

        1. The doctors participating in the operation and catheterization in clinical trials should
           be at least attendings, so as to ensure the safety of operation and chest tube
           placement.

        2. The chest tube placement was carried out randomly with two arms.

        3. From our previous clinical experience, the tube is placed for 3 days to 2 weeks, so it
           last for a short time, and all of them can be extubated by doctors above the attending
           level, so the detachment rate of the experiment is low and the quality can be
           guaranteed.

        4. The trial team has written the test related procedures into the team medical process,
           including but not limited to the time point of chest X-ray.

      Data checks:

      Data checks will be performed by a individual attending doctor with GCP to compare data
      entered into the registry against predefined rules for range or consistency with other data
      fields in the registry.

      Source data verification:

      Source data verification will be performed by a individual attending doctor with GCP to
      assess the accuracy, completeness, or representativeness of registry data by comparing the
      data to external data sources (for example, medical records, paper or electronic case report
      forms, or interactive voice response systems).

      Data dictionary:

      video assisted thoracoscopic surgery, VATS prophylactic air-extraction catheter, PAEC
      Randomized clinical trial, RCT Non small cell lung cancer, NSCLC

      Standard Operating Procedures:

      Patients recruitment The subjects were recruited on a voluntary basis. If they decide to
      participate in this study, the personal data of subjects participating in the trial are
      confidential. The subject's blood samples will be identified by the study number, not the
      subject's name. Information that identifies the subject will not be disclosed to members
      outside the study team unless permission is obtained from the subject. All study members and
      study sponsors were asked to keep their identities confidential. The subjects' files will be
      kept in a locked file cabinet for researchers' reference only. In order to ensure that the
      study is carried out in accordance with the regulations, members of the government
      administration or the ethics review committee may access the subject's personal data in the
      research unit as required. At the time of publication, no personal information will be
      disclosed.

      data collection All the patients learned about the two kinds of operation through
      preoperative education, and voluntarily joined the research group and signed the ethical
      agreement. In this clinical trial, patients were enrolled in the randomized controlled trial.
      The members of the experimental group were only responsible for the inclusion and exclusion
      of patients. The surgeons and assistants did not participate in the preoperative evaluation
      and postoperative management. The pain assessment team, postoperative management personnel
      and follow-up evaluators did not know what group the patients belonged to (patients could
      wear wide clothes to cover the drainage tube after operation)

      change management In cases with serious medical risk caused by the operation technology of
      the trial, or the research indicates that the difference between the groups is too obvious,
      the researcher should stop the trial and fill in the report form of violation of protocol
      deviation and report to the ethics committee.

      If the patients were enrolled normally and reached the number of cases required for the
      trial, the trial was finished.

      reporting for adverse events

        1. The sponsor shall provide the safety research data of the technology and other safety
           related information.

        2. In the design scheme, the definition of adverse events should be clearly defined, and
           the criteria for judging the severity of adverse events, as well as the classification
           criteria for judging the relationship between adverse events and experimental operation
           (such as positively related, possibly related, possibly unrelated, irrelevant and unable
           to be determined). The protocol requires researchers to truthfully fill in the adverse
           event record form, recording the occurrence time, severity, duration, measures taken and
           outcome.

        3. Before starting the trial, the members of the research team must be familiar with the
           contents of the prevention and treatment of subjects and emergency plans in medical
           treatment.

        4. In case of SAE, the research physician must report to the project leader, the food and
           drug administration, the sponsor, the medical ethics committee of our hospital, the
           center ethics, and the office of drug clinical trial institution within 24 hours. When
           and by what means (e.g. telephone, fax or written) to whom SAE was reported should be
           recorded in the original data.

        5. The original medical ethics committee reports the paper version, including the receipt
           page (with PI signature), SAE form and processing process in triplicate, and then
           reports the electronic version of PPT, which is then sent to wangxing5447@126.com

        6. To study the doctor according to the implementation of treatment, if necessary, start to
           prevent and deal with medical subjects and emergency plans.

        7. At the same time, the research doctor should make a record of SAE, including at least
           the description of adverse events, occurrence time, termination time, degree and
           frequency of seizures, and the treatment given.

        8. The medical ethics committee will hold a meeting to organize experts to report and
           discuss the SAE and the treatment process in our hospital, and require the follow-up of
           SAE.

      Sample size assessment

      The purpose of this study was to verify whether the new strategy is not inferior to
      traditional method in uniport VATS upper lobe lobectomy. In terms of the incidence of
      pneumothorax (primary), based on previous observational studies, the probability of
      postoperative pneumothorax in new method and traditional method was about 10% and 6%.
      Considering 25% of non-inferiority margin, efficacy analysis estimated that 75 patients in
      each group were required to achieve power of 0.99 (via version 15.0; NCSs, Kaysville, UT,
      USA) with unilateral α of 0.025. Considering some out of groups due to clinical factors or
      other criteria (e.g., changing surgical methods according to pathological results during
      operation, combined with other lobectomy, etc.), a total of 75 subjects in each group were
      required, and 400 is the anticipating case number.

      Plan for missing data The investigators made a plan for missing data to address situations
      where variables are reported as missing, unavailable, non-reported, uninterpretable, or
      considered missing because of data inconsistency or out-of-range results.

      First, sufficient case is planned for the missing data generated from changes in surgery, as
      combined lobectomy or sublobectomies. Second, all the surgeons in our department will be
      informed of this study, and the changes in surgical method should be avoided to their best
      effort.

      Statistical analysis plan

      Statistical analysis will be performed to these select two groups in terms of clinical
      parameters, including the incidence of pneumothorax, reintubation rate, pain score and other
      parameters, respectively using t test, chi square test, rank sum test and other means. SPSS
      20 will be validated to compare the primary and secondary observation end points between the
      two groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is a prospective, randomized, non-inferiority trial, two different drainage strategy will be performed, and both were used routinely in clinical practice. One should be one thoracic tube (28fr drainage tube) was inserted through intercostal incision, and one microtubule (7fr × 20cm) was punctured through the middle line of clavicle, and another will be two conventional chest tubes (28fr or 24fr) were placed through intercostal incision.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Data collected from the X-rays and the pain score evaluation will be masked and the outcomes assessor have no method to get randomized information.
measure: pneumothorax incidence
time frame: 24-30 hours after surgery
description: The incidence of pneumothorax on day 1 after operation
measure: pain scores
time frame: 1day, 3days and 30 days after surgery
description: pain scores collected after surgery
measure: Extubation time
time frame: within 30 days after surgery
description: Extubation time after operation
measure: Total volume
time frame: 1 day after surgery
description: Total volume of pleural effusion on the first day after operation
arm group label: New method
arm group type: Experimental
description: One thoracic tube (28fr drainage tube) was inserted through intercostal incision, and one microtubule (7fr × 20cm) was punctured through the middle line of clavicle
arm group label: Traditional method
arm group type: Placebo Comparator
description: Two conventional chest tubes (28fr or 24fr) were placed through intercostal incision
intervention type: Procedure
intervention name: prophylactic air-extraction catheter drainage
description: This is a kind of venous catheter commonly used in clinic. It may bring less pain after being inserted into the chest, with an equivalent drainage effect with traditional thick drainage tube from our experience, especially in the aspect of gas drainage effect.
arm group label: New method
arm group label: Traditional method
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Tao Gui, MD
role: Study Chair
affiliation: Tongji University School of Medicine
last name: Xing Wang, MD
phone: +8615901013210
email: wangxing5447@126.com
last name: Jiang Fan, MD
phone: +86-21-65115006
email: fan_jiang@tongji.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
citation: Mun M, Nakao M, Matsuura Y, Ichinose J, Nakagawa K, Okumura S. Video-assisted thoracoscopic surgery lobectomy for non-small cell lung cancer. Gen Thorac Cardiovasc Surg. 2018 Nov;66(11):626-631. doi: 10.1007/s11748-018-0979-x. Epub 2018 Jul 30.
PMID: 30062622
citation: Bulgarelli Maqueda L, Garcia-Perez A, Minasyan A, Gonzalez-Rivas D. Uniportal VATS for non-small cell lung cancer. Gen Thorac Cardiovasc Surg. 2020 Jul;68(7):707-715. doi: 10.1007/s11748-019-01221-4. Epub 2019 Oct 15.
PMID: 31617147
citation: Zhang JT, Dong S, Chu XP, Lin SM, Yu RY, Jiang BY, Liao RQ, Nie Q, Yan HH, Yang XN, Wu YL, Zhong WZ. Randomized Trial of an Improved Drainage Strategy Versus Routine Chest Tube After Lung Wedge Resection. Ann Thorac Surg. 2020 Apr;109(4):1040-1046. doi: 10.1016/j.athoracsur.2019.11.029. Epub 2020 Jan 8.
PMID: 31926158
citation: Liu CY, Hsu PK, Leong KI, Ting CK, Tsou MY. Is tubeless uniportal video-assisted thoracic surgery for pulmonary wedge resection a safe procedure? Eur J Cardiothorac Surg. 2020 Aug 1;58(Suppl_1):i70-i76. doi: 10.1093/ejcts/ezaa061.
PMID: 32182334
responsible party type: Principal Investigator
investigator affiliation: Tongji University
investigator full name: Jiang Fan
investigator title: Associate professor
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No