xml: <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/NCT06029621</url>
    </required_header>
    <id_info>
      <org_study_id>STAR006</org_study_id>
      <nct_id>NCT06029621</nct_id>
    </id_info>
    <brief_title>Robot-assisted vs VATS for Thymoma</brief_title>
    <official_title>Comparison of Short-term and Longterm Outcomes Between Robot-assisted Thoracoscopy and Television-assisted Thoracoscopy Surgery Forthymoma : a Multicenter, Prospective, Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Pulmonary Hospital, Shanghai, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Pulmonary Hospital, Shanghai, China</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>
        The aim of this study is to explore the advantages of robot-assisted thymectomy in long-term&#xD;
        survival benefits and short-term clinical efficacy compared with video-assisted thoracoscopic&#xD;
        thymectomy based on a multi-center, prospective, randomized controlled clinical trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Video-assisted thoracoscopic surgery ( VATS ) is widely used in thoracic surgery and has&#xD;
        gradually replaced traditional thoracotomy in thymoma. As a new type of VATS, the long-term&#xD;
        oncological results of robot-assisted thoracoscopic surgery in thymoma have not been&#xD;
        verified. Therefore, we designed a multicenter, prospective, randomized controlled clinical&#xD;
        trial to determine whether RATS thymectomy is as effective as VATS thymectomy in terms of&#xD;
        short-term and long-term outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">September 19, 2030</completion_date>
    <primary_completion_date type="Anticipated">September 19, 2030</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>RATS versus VATS</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>no masking</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>5-year overall survival (OS)</measure>
      <time_frame>5 year after surgery</time_frame>
      <description>OS at 5 year after surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain score</measure>
      <time_frame>at 1 year after surgery</time_frame>
      <description>Pain was assessed using a pain scale on the first day, 1 month, 6 months and 1 year after surgery. Pain was evaluated using the visual analogue scale (VAS) and the numerical rating scale (NRS), with higher scores indicating greater pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>quality of life (QOL) at 1 year by EORTC QLQ-C30</measure>
      <time_frame>at 1 year after surgery</time_frame>
      <description>Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Organization for the Treatment and Research of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>quality of life (QOL) at 1 year by EQ-5D</measure>
      <time_frame>at 1 year after surgery</time_frame>
      <description>Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Five Dimensional Health Scale (EQ-5D).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>R0 rate</measure>
      <time_frame>postoperative in-hospital stay up to 30 days</time_frame>
      <description>R0 radical rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>operative time</measure>
      <time_frame>Intraoperative</time_frame>
      <description>the time of operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>blood loss</measure>
      <time_frame>Intraoperative</time_frame>
      <description>blood loss in the operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>conversion rate</measure>
      <time_frame>Intraoperative</time_frame>
      <description>the rate of conversion to open surgery in the operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of hospital stay (LOS)</measure>
      <time_frame>postoperative in-hospital stay up to 30 days</time_frame>
      <description>length of stay in hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Catheterization days</measure>
      <time_frame>postoperative in-hospital stay up to 30 days</time_frame>
      <description>The interval days from the completion of catheter insertion to the removal of the thoracic tube</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of drainage</measure>
      <time_frame>postoperative in-hospital stay up to 30 days</time_frame>
      <description>Volume of drainage from the completion of catheter insertion to the removal of the thoracic tube</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative complications</measure>
      <time_frame>postoperative in-hospital stay up to 30 days</time_frame>
      <description>mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>30-day mortality</measure>
      <time_frame>postoperative in-hospital stay up to 30 days</time_frame>
      <description>30-day mortality after surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>30-day readmission rate after surgery</measure>
      <time_frame>postoperative in-hospital stay up to 30 days</time_frame>
      <description>Rate of readmission due to postoperative complications</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5-year disease-free survival (DFS)</measure>
      <time_frame>5 year after surgery</time_frame>
      <description>DFS at 5 year after surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor recurrence rate</measure>
      <time_frame>5 year after surgery</time_frame>
      <description>The rate of recurrence of thymoma in patients after surgery</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">304</enrollment>
    <condition>Thymoma</condition>
    <arm_group>
      <arm_group_label>RATS for Thymectomy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The operator of the surgical incision and the route of entry were determined, and the endoscope and surgical instruments were inserted through the operating hole. The phrenic nerve and diaphragm began to gradually separate upward while avoiding nerve damage. Subsequently, the innominate vein was dissected to observe the branches of the thymus vessels and clamped with a 5 mm Hem-o-Lok clamp. Continue to dissect the left side of the thymus until near the phrenic nerve. After the thymus was removed entirely, it was placed in a bag and removed through an incision. After the operation, a 28 Fr chest tube was placed through the incision to the chest top. An 18 G central venous catheter was placed at the level of the posterior axillary line to the posterior costophrenic angle, and about 10 cm was inserted.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>VATS for Thymectomy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The main operation principles and procedures of the operation are basically similar to those of the RATS and are completed under video-assisted thoracoscopic surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>RATS for Thymectomy</intervention_name>
      <description>a minimally invasive surgical type for Thymoma: RATS</description>
      <arm_group_label>RATS for Thymectomy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>VATS for Thymectomy</intervention_name>
      <description>a minimally invasive surgical type for Thymoma: VATS</description>
      <arm_group_label>VATS for Thymectomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ) The age of the subjects on the day of signing the informed consent was ≥ 18 years&#xD;
               old and &lt; 75 years old, regardless of gender ;&#xD;
  &#xD;
            2. ) Chest thin-layer CT and MR showed anterior mediastinal space-occupying lesions,&#xD;
               combined with relevant hematological indicators, the patient was clinically diagnosed&#xD;
               as a thymic epithelial tumor with or without myasthenia gravis ( MG ) symptoms.&#xD;
  &#xD;
            3. ) need to accept thymectomy surgery ;&#xD;
  &#xD;
            4. ) Clinical stage I to IIIA ( AJCC-UICC TNM staging system ) ;&#xD;
  &#xD;
            5. ) The maximum diameter of the lesion &lt; 5cm ;&#xD;
  &#xD;
            6. ) physical condition score 0 or 1 ( Eastern Cooperative Oncology Group ECOG scoring&#xD;
               system ) ;&#xD;
  &#xD;
            7. ) Have not received any anti-thymoma therapy before, including but not limited to&#xD;
               systemic chemotherapy, radiotherapy, etc. ;&#xD;
  &#xD;
            8. ) Preoperative major organ function meets the following criteria : Bone marrow&#xD;
               function: hemoglobin ≥ 10.0 g / dL ( no blood transfusion within 28 days before&#xD;
               hemoglobin examination ), absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥&#xD;
               100 × 109 / L ( no transfusion of apheresis platelets or IL-11 treatment within 14&#xD;
               days before platelet count examination ) ; coagulation function : INR and PT &lt; 1.5 ×&#xD;
               ULN, APTT ≤ 1.5 × ULN ; liver function: transaminase ( ALT and AST ) ≤ 2.5 × ULN;&#xD;
               total bilirubin ≤ 1.5 × ULN ( Gilbert's syndrome or liver metastasis subjects total&#xD;
               bilirubin ≤ 2.5 × ULN ) ; renal function: serum creatinine clearance rate ≥ 60 mL/min&#xD;
               ( calculated according to the Cockcroft-Gault formula ) ;&#xD;
  &#xD;
            9. ) voluntarily participated in and were able to undergo robot-assisted or thoracoscopic&#xD;
               thymectomy, and complied with the study follow-up plan.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. ) Patients with myasthenia gravis crisis ;&#xD;
  &#xD;
            2. ) had undergone mediastinal surgery or cardiac surgery ;&#xD;
  &#xD;
            3. ) body mass index ( BMI ) ≥ 30 ;&#xD;
  &#xD;
            4. ) Patients with severe liver and kidney dysfunction ( ALT and/or AST more than three&#xD;
               times the upper limit of normal, Cr more than the upper limit of normal ) ;&#xD;
  &#xD;
            5. ) combined with severe chronic lung diseases such as COPD, asthma, or interstitial&#xD;
               lung disease ;&#xD;
  &#xD;
            6. ) suffering from uncontrolled heart, kidney, gastrointestinal, and infectious diseases&#xD;
               and other complications ;&#xD;
  &#xD;
            7. ) patients with other malignant tumors or hematological diseases ;&#xD;
  &#xD;
            8. ) combined with chronic pain or preoperative use of opioid analgesics ;&#xD;
  &#xD;
            9. ) patients with thoracic deformity or combined with pectus carinatum and pectus&#xD;
               excavatum ;&#xD;
  &#xD;
           10. ) have mental disorders, such as anxiety disorders ;&#xD;
  &#xD;
           11. ) pregnant and/or lactating women ;&#xD;
  &#xD;
           12. ) is currently participating in other interventional clinical studies.&#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>Deping Zhao, MD,PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Pulmonary Hospital, School of Medicine, Tongji University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Juemin Yu</last_name>
      <phone>+8615927548511</phone>
      <email>yujm96@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Deping Zhao, MD,PhD</last_name>
      <phone>+8613701816883</phone>
      <email>zdp1992@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shanghai Pulmonary Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital Zhejiang University School of Medicine</name>
        <address>
          <city>Zhejiang</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Junqiang Fan</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai Pulmonary Hospital, Shanghai, China</investigator_affiliation>
      <investigator_full_name>Deping Zhao</investigator_full_name>
      <investigator_title>Administrative Director of Thoracic Surgery Department</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thymoma</mesh_term>
      <mesh_term>Thymus Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029621
  org study id: STAR006
  nct id: NCT06029621
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to explore the advantages of robot-assisted thymectomy in long-term
        survival benefits and short-term clinical efficacy compared with video-assisted thoracoscopic
        thymectomy based on a multi-center, prospective, randomized controlled clinical trial.
  Video-assisted thoracoscopic surgery ( VATS ) is widely used in thoracic surgery and has
        gradually replaced traditional thoracotomy in thymoma. As a new type of VATS, the long-term
        oncological results of robot-assisted thoracoscopic surgery in thymoma have not been
        verified. Therefore, we designed a multicenter, prospective, randomized controlled clinical
        trial to determine whether RATS thymectomy is as effective as VATS thymectomy in terms of
        short-term and long-term outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: RATS versus VATS
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: no masking
  measure: 5-year overall survival (OS)
  time frame: 5 year after surgery
  description: OS at 5 year after surgery
  measure: Pain score
  time frame: at 1 year after surgery
  description: Pain was assessed using a pain scale on the first day, 1 month, 6 months and 1 year after surgery. Pain was evaluated using the visual analogue scale (VAS) and the numerical rating scale (NRS), with higher scores indicating greater pain
  measure: quality of life (QOL) at 1 year by EORTC QLQ-C30
  time frame: at 1 year after surgery
  description: Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Organization for the Treatment and Research of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0
  measure: quality of life (QOL) at 1 year by EQ-5D
  time frame: at 1 year after surgery
  description: Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Five Dimensional Health Scale (EQ-5D).
  measure: R0 rate
  time frame: postoperative in-hospital stay up to 30 days
  description: R0 radical rate
  measure: operative time
  time frame: Intraoperative
  description: the time of operation
  measure: blood loss
  time frame: Intraoperative
  description: blood loss in the operation
  measure: conversion rate
  time frame: Intraoperative
  description: the rate of conversion to open surgery in the operation
  measure: length of hospital stay (LOS)
  time frame: postoperative in-hospital stay up to 30 days
  description: length of stay in hospitalization
  measure: Catheterization days
  time frame: postoperative in-hospital stay up to 30 days
  description: The interval days from the completion of catheter insertion to the removal of the thoracic tube
  measure: Volume of drainage
  time frame: postoperative in-hospital stay up to 30 days
  description: Volume of drainage from the completion of catheter insertion to the removal of the thoracic tube
  measure: postoperative complications
  time frame: postoperative in-hospital stay up to 30 days
  description: mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
  measure: 30-day mortality
  time frame: postoperative in-hospital stay up to 30 days
  description: 30-day mortality after surgery
  measure: 30-day readmission rate after surgery
  time frame: postoperative in-hospital stay up to 30 days
  description: Rate of readmission due to postoperative complications
  measure: 5-year disease-free survival (DFS)
  time frame: 5 year after surgery
  description: DFS at 5 year after surgery
  measure: Tumor recurrence rate
  time frame: 5 year after surgery
  description: The rate of recurrence of thymoma in patients after surgery
  arm group label: RATS for Thymectomy
  arm group type: Experimental
  description: The operator of the surgical incision and the route of entry were determined, and the endoscope and surgical instruments were inserted through the operating hole. The phrenic nerve and diaphragm began to gradually separate upward while avoiding nerve damage. Subsequently, the innominate vein was dissected to observe the branches of the thymus vessels and clamped with a 5 mm Hem-o-Lok clamp. Continue to dissect the left side of the thymus until near the phrenic nerve. After the thymus was removed entirely, it was placed in a bag and removed through an incision. After the operation, a 28 Fr chest tube was placed through the incision to the chest top. An 18 G central venous catheter was placed at the level of the posterior axillary line to the posterior costophrenic angle, and about 10 cm was inserted.
  arm group label: VATS for Thymectomy
  arm group type: Active Comparator
  description: The main operation principles and procedures of the operation are basically similar to those of the RATS and are completed under video-assisted thoracoscopic surgery.
  intervention type: Procedure
  intervention name: RATS for Thymectomy
  description: a minimally invasive surgical type for Thymoma: RATS
  arm group label: RATS for Thymectomy
  intervention type: Procedure
  intervention name: VATS for Thymectomy
  description: a minimally invasive surgical type for Thymoma: VATS
  arm group label: VATS for Thymectomy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Deping Zhao, MD,PhD
  role: Principal Investigator
  affiliation: Shanghai Pulmonary Hospital, School of Medicine, Tongji University
  last name: Juemin Yu
  phone: +8615927548511
  email: yujm96@163.com
  last name: Deping Zhao, MD,PhD
  phone: +8613701816883
  email: zdp1992@163.com
  facility: 
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai Pulmonary Hospital, Shanghai, China
  investigator full name: Deping Zhao
  investigator title: Administrative Director of Thoracic Surgery Department
  mesh term: Thymoma
  mesh term: Thymus Neoplasms
  sharing ipd: No