<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/NCT03252210</url>
  </required_header>
  <id_info>
    <org_study_id>PSL-1</org_study_id>
    <nct_id>NCT03252210</nct_id>
  </id_info>
  <brief_title>Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection</brief_title>
  <acronym>PSLVML</acronym>
  <official_title>Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Patients With Lung Wedge Resection:A Prospective Self-control Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 feasibility，accuracy and safety of Preoperative Stereoscopic&#xD;
      Localization Versus Methylene Blue Localization in GGO Wedge Resection. In the first&#xD;
      stage，participants will receive both Preoperative Stereoscopic Localization and Methylene&#xD;
      Blue Localization .In the second stage,participants only receive Preoperative Stereoscopic&#xD;
      Localization for Wedge Resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More and more Ground Glass Opacity（GGO）are detected because of the early screening.According&#xD;
      to Fleischner Society, for some solid GGO, surgical resection should be performed if the&#xD;
      solid component is larger than 5mm.With the development of video-assisted thoracoscopic&#xD;
      surgery (VATS) techniques, minimally invasive thoracic surgery has evolved considerably over&#xD;
      the last three decades.However, localizing the small sized pulmonary nodules during VATS is&#xD;
      challenging when there is no change in visceral pleura.&#xD;
&#xD;
      Several traditional techniques have been described to localize peripheral pulmonary nodules,&#xD;
      including preoperative CT-guided tattooing with methylene blue, CT scan guided spiral/hook&#xD;
      wire placement and marking with radio-opaque materials. The traditional marking method have&#xD;
      its strong and weak points. For the strong point, It provide a credible and precise nodule&#xD;
      location to the surgeon. For the weak points:(1)a potential risk of pneumothorax and&#xD;
      hemothorax.(2)Methylene blue have a tendency to diffuse over a large area during surgical&#xD;
      preparation until the nodule's location is confirmed.(3)The Preoperative localization&#xD;
      technique would need more time for the Preoperative preparation, which would be reduce the&#xD;
      transport's efficiency.(4)It would occupy the resource of CT's usage.(5)Some of the methods&#xD;
      ,such as methylene blue, maybe interference with the Pathological diagnosis.(6)These methods&#xD;
      are all invasive operation, would Cause the patients' psychological fear.&#xD;
&#xD;
      In order to avoid these weak points，the investigators use a new localization technique which&#xD;
      has three basic steps: 1.Confirm the nodule's location in pulmonary segments. 2.Measure the&#xD;
      distance between the nodule and anatomic landmarks on CT. 3. Estimate the changes of the&#xD;
      distance between the nodule and anatomic landmarks after the alveolar atelectasis. The&#xD;
      investigators have already succeed in some case.But,the further study is needed.Hence,the&#xD;
      investigators designed a prospective study of Preoperative Stereoscopic Localization Versus&#xD;
      Methylene Blue Localization in GGO Wedge Resection.Then,the investigators evaluate the&#xD;
      feasibility，accuracy and safety of Preoperative Stereoscopic Localization Versus Methylene&#xD;
      Blue Localization in GGO Wedge Resection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 16, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single group self-control study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Eventhough only one group of participants，different investigators perform two kinds of localization techniques.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>success rate of Stereoscopic Localization</measure>
    <time_frame>3 day</time_frame>
    <description>Success localization means that the distance from lession to anchor point is less than 3.0 cm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison between Stereoscopic Localization success rate and Methylene Blue Localization success rate</measure>
    <time_frame>3 day</time_frame>
    <description>To evaluate the two kinds of Localization.Success localization means that the distance from lession to anchor point is less than 3.0 cm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance from A to B</measure>
    <time_frame>3 day</time_frame>
    <description>A:lession B：methylene blue anchor point To evaluate the accuracy of methylene blue localization.Measure the distance from lession to the methylene blue localization anchor point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance from A to C</measure>
    <time_frame>3 day</time_frame>
    <description>A:lession C：Stereoscopic Localization anchor point To evaluate the accuracy of Stereoscopic Localization localization.Measure the distance from lession to the Stereoscopic Localization localization anchor point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance from B to C</measure>
    <time_frame>3 day</time_frame>
    <description>B：methylene blue anchor point C：Stereoscopic Localization anchor point To evaluate the two kinds of Localization.Measure the distance from methylene blue localization anchor point to the stereoscopic localization anchor point .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The success rate of wedge resection</measure>
    <time_frame>3 day</time_frame>
    <description>To evaluate the accuracy rate of localization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative adverse event incidence rate</measure>
    <time_frame>1 months</time_frame>
    <description>To evaluate the incidence rate of pneumothorax or perilesional hemorrhage in participants</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Thoracic Surgery, Video-Assisted</condition>
  <arm_group>
    <arm_group_label>Stereoscopic Versus Methylene Blue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the same participant,we perform both Stereoscopic and Methylene Blue localization。Then，compare the distance between the methylene blue's anchor point and the location of lesion,stereoscopic Localization's anchor point and the location of lesion,methylene blue's anchor point and stereoscopic Localization's anchor point.&#xD;
Post Hoc Multiple Comparisons</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Preoperative Stereoscopic Localization</intervention_name>
    <description>1.Confirm the nodule's location and measure the distance between the nodule and anatomic landmarks from the CT scan. 2.According to the results of the first step，confirm the needle puncture site of the chest wall. 3.After general anesthesia and Patient positioning are completed, the needle is then inserted via the needle puncture site .</description>
    <arm_group_label>Stereoscopic Versus Methylene Blue</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Preoperative radiology revealed the solid component of GGO is larger than 5mm&#xD;
&#xD;
          2. Preoperative radiology revealed peripheral pulmonary nodule, with both size and depth&#xD;
             less than 3 cm&#xD;
&#xD;
          3. Preoperative radiology revealed the distance from the lesion to the visceral pleura is&#xD;
             larger than 5 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Preoperative radiology revealed pneumonia or atelectasis&#xD;
&#xD;
          2. 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;
          3. Bleeding tendency or anticoagulant use&#xD;
&#xD;
          4. Pregnancy or breast feeding&#xD;
&#xD;
          5. Patient who can not sign permit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</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, Ph.D</last_name>
    <phone>18820792959</phone>
    <email>18820792959@163.com</email>
  </overall_contact>
  <reference>
    <citation>Kleedehn M, Kim DH, Lee FT, Lubner MG, Robbins JB, Ziemlewicz TJ, Hinshaw JL. Preoperative Pulmonary Nodule Localization: A Comparison of Methylene Blue and Hookwire Techniques. AJR Am J Roentgenol. 2016 Dec;207(6):1334-1339. doi: 10.2214/AJR.16.16272. Epub 2016 Sep 22.</citation>
    <PMID>27657546</PMID>
  </reference>
  <reference>
    <citation>Wicky S, Mayor B, Schnyder P. Methylene blue localizations of pulmonary nodules under CT-guidance: a new procedure used before thoracoscopic resections. Int Surg. 1997 Jan-Mar;82(1):15-7.</citation>
    <PMID>9189791</PMID>
  </reference>
  <reference>
    <citation>Wicky S, Mayor B, Cuttat JF, Schnyder P. CT-guided localizations of pulmonary nodules with methylene blue injections for thoracoscopic resections. Chest. 1994 Nov;106(5):1326-8. doi: 10.1378/chest.106.5.1326.</citation>
    <PMID>7956378</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial People's Hospital</investigator_affiliation>
    <investigator_full_name>Wen-zhao ZHONG</investigator_full_name>
    <investigator_title>Deputy director of Guangdong lung cancer institute</investigator_title>
  </responsible_party>
  <keyword>Preoperative localization</keyword>
  <keyword>Stereoscopic Localization</keyword>
  <keyword>Wedge Resection</keyword>
  <keyword>Ground Glass Opacity</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/NCT03252210
org study id: PSL-1
nct id: NCT03252210
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the feasibility，accuracy and safety of Preoperative Stereoscopic
      Localization Versus Methylene Blue Localization in GGO Wedge Resection. In the first
      stage，participants will receive both Preoperative Stereoscopic Localization and Methylene
      Blue Localization .In the second stage,participants only receive Preoperative Stereoscopic
      Localization for Wedge Resection.
More and more Ground Glass Opacity（GGO）are detected because of the early screening.According
      to Fleischner Society, for some solid GGO, surgical resection should be performed if the
      solid component is larger than 5mm.With the development of video-assisted thoracoscopic
      surgery (VATS) techniques, minimally invasive thoracic surgery has evolved considerably over
      the last three decades.However, localizing the small sized pulmonary nodules during VATS is
      challenging when there is no change in visceral pleura.

      Several traditional techniques have been described to localize peripheral pulmonary nodules,
      including preoperative CT-guided tattooing with methylene blue, CT scan guided spiral/hook
      wire placement and marking with radio-opaque materials. The traditional marking method have
      its strong and weak points. For the strong point, It provide a credible and precise nodule
      location to the surgeon. For the weak points:(1)a potential risk of pneumothorax and
      hemothorax.(2)Methylene blue have a tendency to diffuse over a large area during surgical
      preparation until the nodule's location is confirmed.(3)The Preoperative localization
      technique would need more time for the Preoperative preparation, which would be reduce the
      transport's efficiency.(4)It would occupy the resource of CT's usage.(5)Some of the methods
      ,such as methylene blue, maybe interference with the Pathological diagnosis.(6)These methods
      are all invasive operation, would Cause the patients' psychological fear.

      In order to avoid these weak points，the investigators use a new localization technique which
      has three basic steps: 1.Confirm the nodule's location in pulmonary segments. 2.Measure the
      distance between the nodule and anatomic landmarks on CT. 3. Estimate the changes of the
      distance between the nodule and anatomic landmarks after the alveolar atelectasis. The
      investigators have already succeed in some case.But,the further study is needed.Hence,the
      investigators designed a prospective study of Preoperative Stereoscopic Localization Versus
      Methylene Blue Localization in GGO Wedge Resection.Then,the investigators evaluate the
      feasibility，accuracy and safety of Preoperative Stereoscopic Localization Versus Methylene
      Blue Localization in GGO Wedge Resection.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group self-control study
primary purpose: Other
masking: None (Open Label)
masking description: Eventhough only one group of participants，different investigators perform two kinds of localization techniques.
measure: success rate of Stereoscopic Localization
time frame: 3 day
description: Success localization means that the distance from lession to anchor point is less than 3.0 cm.
measure: Comparison between Stereoscopic Localization success rate and Methylene Blue Localization success rate
time frame: 3 day
description: To evaluate the two kinds of Localization.Success localization means that the distance from lession to anchor point is less than 3.0 cm.
measure: Distance from A to B
time frame: 3 day
description: A:lession B：methylene blue anchor point To evaluate the accuracy of methylene blue localization.Measure the distance from lession to the methylene blue localization anchor point
measure: Distance from A to C
time frame: 3 day
description: A:lession C：Stereoscopic Localization anchor point To evaluate the accuracy of Stereoscopic Localization localization.Measure the distance from lession to the Stereoscopic Localization localization anchor point
measure: Distance from B to C
time frame: 3 day
description: B：methylene blue anchor point C：Stereoscopic Localization anchor point To evaluate the two kinds of Localization.Measure the distance from methylene blue localization anchor point to the stereoscopic localization anchor point .
measure: The success rate of wedge resection
time frame: 3 day
description: To evaluate the accuracy rate of localization
measure: Postoperative adverse event incidence rate
time frame: 1 months
description: To evaluate the incidence rate of pneumothorax or perilesional hemorrhage in participants
arm group label: Stereoscopic Versus Methylene Blue
arm group type: Experimental
description: In the same participant,we perform both Stereoscopic and Methylene Blue localization。Then，compare the distance between the methylene blue's anchor point and the location of lesion,stereoscopic Localization's anchor point and the location of lesion,methylene blue's anchor point and stereoscopic Localization's anchor point.
Post Hoc Multiple Comparisons
intervention type: Procedure
intervention name: Preoperative Stereoscopic Localization
description: 1.Confirm the nodule's location and measure the distance between the nodule and anatomic landmarks from the CT scan. 2.According to the results of the first step，confirm the needle puncture site of the chest wall. 3.After general anesthesia and Patient positioning are completed, the needle is then inserted via the needle puncture site .
arm group label: Stereoscopic Versus Methylene Blue
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wen-Zhao Zhong, Ph.D
role: Principal Investigator
affiliation: Guangdong Provincial People's Hospital
last name: Wen-Zhao Zhong, Ph.D
phone: 18820792959
email: 18820792959@163.com
citation: Kleedehn M, Kim DH, Lee FT, Lubner MG, Robbins JB, Ziemlewicz TJ, Hinshaw JL. Preoperative Pulmonary Nodule Localization: A Comparison of Methylene Blue and Hookwire Techniques. AJR Am J Roentgenol. 2016 Dec;207(6):1334-1339. doi: 10.2214/AJR.16.16272. Epub 2016 Sep 22.
PMID: 27657546
citation: Wicky S, Mayor B, Schnyder P. Methylene blue localizations of pulmonary nodules under CT-guidance: a new procedure used before thoracoscopic resections. Int Surg. 1997 Jan-Mar;82(1):15-7.
PMID: 9189791
citation: Wicky S, Mayor B, Cuttat JF, Schnyder P. CT-guided localizations of pulmonary nodules with methylene blue injections for thoracoscopic resections. Chest. 1994 Nov;106(5):1326-8. doi: 10.1378/chest.106.5.1326.
PMID: 7956378
responsible party type: Principal Investigator
investigator affiliation: Guangdong Provincial People's Hospital
investigator full name: Wen-zhao ZHONG
investigator title: Deputy director of Guangdong lung cancer institute
sharing ipd: No