<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/NCT04443478</url>
  </required_header>
  <id_info>
    <org_study_id>CLASS-10</org_study_id>
    <nct_id>NCT04443478</nct_id>
  </id_info>
  <brief_title>Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Esophagogastric Junction Cancer</brief_title>
  <official_title>Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Siewert Type II/III Adenocarcinoma of Esophagogastric Junction: an Exploratory, Prospective, Observational, IDEAL Stage 2, Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changzhi People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Medical University Union Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xijing hospital of air force Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Qingdao University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Qinghai University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Xiamen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanxi Province Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Hospital of China Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Mediastinal lymph node dissection has been adopted as standard treatment for adenocarcinoma&#xD;
      of esophagogastric junction(AEJ). This multi-center, exploratory, prospective, cohort study&#xD;
      aims at provide standard technical details of laparoscopic mediastinal lymph node dissection,&#xD;
      and explore the potential clinical effects, gather key information for following study&#xD;
      regarding sample size calculation, primary outcome and feasibility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Lower mediastinal lymph node dissection has been adopted as standard by&#xD;
      treatment guideline for adenocarcinoma of esophagogastric junction(AEJ), but the effect of&#xD;
      laparoscopic mediastinal lymph node dissection remains unknown. The aim of this study is to&#xD;
      provide standard technical details of laparoscopic mediastinal lymph node dissection, and&#xD;
      explore the potential clinical effects, gather key information for following study regarding&#xD;
      sample size calculation, primary outcome and feasibility. This study report intervention&#xD;
      development, governance procedures and selection and reporting of outcomes to optimize&#xD;
      methods for using the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL)&#xD;
      framework for surgical innovation that informs evidence-based practice.&#xD;
&#xD;
      Methods and analysis: This is an IDEAL stage II, prospective, parallel control, open label,&#xD;
      multi-center and exploratory study. The inclusion criteria is Siewert II/ III, AEJ,&#xD;
      cT2-4aN0-3M0(AJCC-8th Gastric Cancer TNM stage manual), decide to receive radical&#xD;
      gastrectomy, without preoperative anti-neoplastic therapy. The individual included in the&#xD;
      study is performed the radical total or proximal gastrectomy plus the lower mediastinal&#xD;
      lymphadenectomy via either laparoscopic (trial arm) or open (control arm) TH approach. The&#xD;
      surgical approach is determined by the investigator in each center before the operation and&#xD;
      recorded in the electronic case report forms (CRF).&#xD;
&#xD;
      The primary outcome is the number of lower mediastinal lymph nodes retrieved. Secondary&#xD;
      outcome include complication, surgery length, postoperative death, R0 resection rate, etc.&#xD;
      Expected sample size is 518 in each group, thus has 80% power to detect a difference of 0.17&#xD;
      in the average number of lower mediastinal lymph node dissected in between two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>The number of lower mediastinal lymph nodes retrieved</measure>
    <time_frame>immediately after the pathology report issued</time_frame>
    <description>The number of lower mediastinal lymph nodes retrieved</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of complication during Lower Mediastinal Lymphadenectomy</measure>
    <time_frame>immediately after the surgery</time_frame>
    <description>Complication during Lower Mediastinal Lymphadenectomy &amp; anastomosis, including damage of pericardium, esophagus, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of postoperative complication after Lower Mediastinal Lymphadenectomy</measure>
    <time_frame>Day 30 after surgery</time_frame>
    <description>Postoperative complication after Lower Mediastinal Lymphadenectomy, including leakage, bleeding, etc, complication related with Lower Mediastinal Lymphadenectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time length of Lower Mediastinal Lymphadenectomy</measure>
    <time_frame>immediately after the surgery</time_frame>
    <description>Time length of Lower Mediastinal Lymphadenectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Postoperative complication</measure>
    <time_frame>Day 30 after surgery</time_frame>
    <description>Any complication within 30d after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of postoperative death</measure>
    <time_frame>Day 30 after surgery</time_frame>
    <description>death within 30 days after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of unscheduled reoperation</measure>
    <time_frame>Day 30 after surgery</time_frame>
    <description>reoperation within 30 days after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of unscheduled readmission</measure>
    <time_frame>Day 30 after surgery</time_frame>
    <description>unscheduled readmission within 30 days after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>immediately after the pathology report issued</time_frame>
    <description>R0 resection rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proximal margin length</measure>
    <time_frame>30minutes after removal of tumor</time_frame>
    <description>from proximal tumor margin to proximal margin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local recurrence of lower mediastinal area in 3 years</measure>
    <time_frame>Year 3 after surgery</time_frame>
    <description>Local recurrence of lower mediastinal area in 3 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of cancer specific death in 3 years</measure>
    <time_frame>Year 3 after surgery</time_frame>
    <description>Rate of cancer specific death in 3 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence free survival in 3 years</measure>
    <time_frame>Year 3 after surgery</time_frame>
    <description>Recurrence free survival in 3 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival in 3 years</measure>
    <time_frame>Year 3 after surgery</time_frame>
    <description>Overall survival in 3 years</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality evaluation index of Lower Mediastinal Lymphadenectomy</measure>
    <time_frame>through study completion, an average of 3 years</time_frame>
    <description>surgical characteristics that are directly related to the safety outcome of surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Learning curve of Lower Mediastinal Lymphadenectomy</measure>
    <time_frame>through study completion, an average of 3 years</time_frame>
    <description>refers to the number of surgical cases corresponding to the transition point</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment tendency of surgeons and patients</measure>
    <time_frame>through study completion, an average of 3 years</time_frame>
    <description>the proportion of persons willing to receive treatment in randomization</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients that can be screened and successfully recruited</measure>
    <time_frame>through study completion, an average of 3 years</time_frame>
    <description>The number of patients that can be screened, excluded, successfully recruited, intervented, and followed up throughout each phase of the study.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1036</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Laparoscopic Surgery</arm_group_label>
    <description>Lower Mediastinal Lymphadenectomy should be finished via laparoscopic method.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open Surgery</arm_group_label>
    <description>Lower Mediastinal Lymphadenectomy should be finished via open method.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical gastrectomy with dissection of lower mediastinal lymph node</intervention_name>
    <description>Radical gastrectomy for gastric cancer should be consistent with Japanese gastric cancer treatment guideline.</description>
    <arm_group_label>Laparoscopic Surgery</arm_group_label>
    <arm_group_label>Open Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pathologically Confirmed esophageal gastric adenocarcinoma, clinical stage cT2-4aN3M0(AJCC&#xD;
        - 8th gastric cancer tumor TNM staging), Siewert Ⅱ/Ⅲ, receive surgical treatment without&#xD;
        preoperative treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-80 years old;&#xD;
&#xD;
          -  Karnofsky score ≥70%;Or ECOG score ≤2;&#xD;
&#xD;
          -  Preoperative pathological biopsy confirmed adenocarcinoma.&#xD;
&#xD;
          -  According to gastroscopy, abdominal CT or upper gastrointestinal angiography, the&#xD;
             tumor site conforms to the definition of esophageal and gastric junction&#xD;
             adenocarcinoma in the &quot;Chinese expert consensus&quot;, that is, the tumor center is within&#xD;
             5cm above and below the esophagogastric anatomical junction and crosses or touches the&#xD;
             esophagogastric junction;&#xD;
&#xD;
          -  Length of esophageal invasion ≤2cm;&#xD;
&#xD;
          -  By abdominal contrast-enhanced CT/MRI, the clinical stage was CT2-4aN0-3M0 (according&#xD;
             to AJCC-8th TNM tumor stage);&#xD;
&#xD;
          -  Subject's blood routine and biochemical indicators meet the following standards:&#xD;
             hemoglobin ≥80g/L; Absolute count of neutrophils (ANC) ≥1.5×109/L; Platelet&#xD;
             ≥75×109/L;ALT and AST≤2.5 times the normal upper limit; ALP≤2.5 times the normal upper&#xD;
             limit; Serum total bilirubin ≤1.5 times the normal upper limit; Serum creatinine ≤ the&#xD;
             normal upper limit; Serum albumin ≥30g/L;&#xD;
&#xD;
          -  Obtain written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any anti-cancerous treatment received prior to surgery.&#xD;
&#xD;
          -  Multiple malignant lesions in the stomach.&#xD;
&#xD;
          -  Suspicious lymph node metastasis in the middle and/or upper mediastinum.&#xD;
&#xD;
          -  Surgical history in the upper abdomen (laparoscopic cholecystectomy excluded).&#xD;
&#xD;
          -  Pregnant or breastfeeding women.&#xD;
&#xD;
          -  Uncontrolled epilepsy, central nervous system disease or mental disorder.&#xD;
&#xD;
          -  The Bulky N2 status.&#xD;
&#xD;
          -  The emergency surgery.&#xD;
&#xD;
          -  Severe heart disease.&#xD;
&#xD;
          -  History of cerebral infarction or cerebral hemorrhage within 6 months.&#xD;
&#xD;
          -  Organ transplant recipients who need immunosuppressive therapies.&#xD;
&#xD;
          -  Other malignancy diagnosed within 5 years (cured dermoid caner and cervical cancer&#xD;
             excluded).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fei Shan, MD</last_name>
      <phone>010-88196598</phone>
      <email>shanfei@hsc.pku.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Zhemin Li, MD</last_name>
      <phone>010-88196598</phone>
      <email>tagzhemin@outlook.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.</citation>
    <PMID>30207593</PMID>
  </reference>
  <reference>
    <citation>Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8. Erratum In: Surg Laparosc Endosc. 2013 Oct;23(5):480.</citation>
    <PMID>8180768</PMID>
  </reference>
  <reference>
    <citation>Markar SR, Dabakuyo-Yonli TS, Piessen G. Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer. Reply. N Engl J Med. 2019 Apr 25;380(17):e28. doi: 10.1056/NEJMc1901650. No abstract available.</citation>
    <PMID>31018084</PMID>
  </reference>
  <reference>
    <citation>Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346.</citation>
    <PMID>26352529</PMID>
  </reference>
  <reference>
    <citation>Hu Y, Huang C, Sun Y, Su X, Cao H, Hu J, Xue Y, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Chen P, Liu H, Zheng C, Liu F, Yu J, Li Z, Zhao G, Chen X, Wang K, Li P, Xing J, Li G. Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Apr 20;34(12):1350-7. doi: 10.1200/JCO.2015.63.7215. Epub 2016 Feb 22.</citation>
    <PMID>26903580</PMID>
  </reference>
  <reference>
    <citation>Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359.</citation>
    <PMID>31135850</PMID>
  </reference>
  <reference>
    <citation>Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.</citation>
    <PMID>32060757</PMID>
  </reference>
  <reference>
    <citation>Kurokawa Y, Takeuchi H, Doki Y, Mine S, Terashima M, Yasuda T, Yoshida K, Daiko H, Sakuramoto S, Yoshikawa T, Kunisaki C, Seto Y, Tamura S, Shimokawa T, Sano T, Kitagawa Y. Mapping of Lymph Node Metastasis From Esophagogastric Junction Tumors: A Prospective Nationwide Multicenter Study. Ann Surg. 2021 Jul 1;274(1):120-127. doi: 10.1097/SLA.0000000000003499.</citation>
    <PMID>31404008</PMID>
  </reference>
  <reference>
    <citation>Sugita S, Kinoshita T, Kaito A, Watanabe M, Sunagawa H. Short-term outcomes after laparoscopic versus open transhiatal resection of Siewert type II adenocarcinoma of the esophagogastric junction. Surg Endosc. 2018 Jan;32(1):383-390. doi: 10.1007/s00464-017-5687-6. Epub 2017 Jun 27.</citation>
    <PMID>28656339</PMID>
  </reference>
  <reference>
    <citation>Sugita S, Kinoshita T, Kuwata T, Tokunaga M, Kaito A, Watanabe M, Tonouchi A, Sato R, Nagino M. Long-term oncological outcomes of laparoscopic versus open transhiatal resection for patients with Siewert type II adenocarcinoma of the esophagogastric junction. Surg Endosc. 2021 Jan;35(1):340-348. doi: 10.1007/s00464-020-07406-w. Epub 2020 Feb 5.</citation>
    <PMID>32025923</PMID>
  </reference>
  <reference>
    <citation>Huang CM, Lv CB, Lin JX, Chen QY, Zheng CH, Li P, Xie JW, Wang JB, Lu J, Cao LL, Lin M, Tu RH. Laparoscopic-assisted versus open total gastrectomy for Siewert type II and III esophagogastric junction carcinoma: a propensity score-matched case-control study. Surg Endosc. 2017 Sep;31(9):3495-3503. doi: 10.1007/s00464-016-5375-y. Epub 2016 Dec 15.</citation>
    <PMID>27981384</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>November 21, 2021</last_update_submitted>
  <last_update_submitted_qc>November 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Jiafu Ji</investigator_full_name>
    <investigator_title>President of Beijing Cancer Hospital</investigator_title>
  </responsible_party>
  <keyword>esophagogastric junction</keyword>
  <keyword>lower mediastinal lymphadenectomy</keyword>
  <keyword>laparoscopic gastrectomy</keyword>
  <keyword>IDEAL framework</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data will be shared after the publication of the results.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After the publication.</ipd_time_frame>
  </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/NCT04443478
org study id: CLASS-10
nct id: NCT04443478
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Mediastinal lymph node dissection has been adopted as standard treatment for adenocarcinoma
      of esophagogastric junction(AEJ). This multi-center, exploratory, prospective, cohort study
      aims at provide standard technical details of laparoscopic mediastinal lymph node dissection,
      and explore the potential clinical effects, gather key information for following study
      regarding sample size calculation, primary outcome and feasibility.
Introduction: Lower mediastinal lymph node dissection has been adopted as standard by
      treatment guideline for adenocarcinoma of esophagogastric junction(AEJ), but the effect of
      laparoscopic mediastinal lymph node dissection remains unknown. The aim of this study is to
      provide standard technical details of laparoscopic mediastinal lymph node dissection, and
      explore the potential clinical effects, gather key information for following study regarding
      sample size calculation, primary outcome and feasibility. This study report intervention
      development, governance procedures and selection and reporting of outcomes to optimize
      methods for using the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL)
      framework for surgical innovation that informs evidence-based practice.

      Methods and analysis: This is an IDEAL stage II, prospective, parallel control, open label,
      multi-center and exploratory study. The inclusion criteria is Siewert II/ III, AEJ,
      cT2-4aN0-3M0(AJCC-8th Gastric Cancer TNM stage manual), decide to receive radical
      gastrectomy, without preoperative anti-neoplastic therapy. The individual included in the
      study is performed the radical total or proximal gastrectomy plus the lower mediastinal
      lymphadenectomy via either laparoscopic (trial arm) or open (control arm) TH approach. The
      surgical approach is determined by the investigator in each center before the operation and
      recorded in the electronic case report forms (CRF).

      The primary outcome is the number of lower mediastinal lymph nodes retrieved. Secondary
      outcome include complication, surgery length, postoperative death, R0 resection rate, etc.
      Expected sample size is 518 in each group, thus has 80% power to detect a difference of 0.17
      in the average number of lower mediastinal lymph node dissected in between two groups.
observational model: Cohort
time perspective: Prospective
measure: The number of lower mediastinal lymph nodes retrieved
time frame: immediately after the pathology report issued
description: The number of lower mediastinal lymph nodes retrieved
measure: Rate of complication during Lower Mediastinal Lymphadenectomy
time frame: immediately after the surgery
description: Complication during Lower Mediastinal Lymphadenectomy & anastomosis, including damage of pericardium, esophagus, etc.
measure: Rate of postoperative complication after Lower Mediastinal Lymphadenectomy
time frame: Day 30 after surgery
description: Postoperative complication after Lower Mediastinal Lymphadenectomy, including leakage, bleeding, etc, complication related with Lower Mediastinal Lymphadenectomy
measure: Time length of Lower Mediastinal Lymphadenectomy
time frame: immediately after the surgery
description: Time length of Lower Mediastinal Lymphadenectomy
measure: Rate of Postoperative complication
time frame: Day 30 after surgery
description: Any complication within 30d after surgery
measure: Rate of postoperative death
time frame: Day 30 after surgery
description: death within 30 days after surgery
measure: Rate of unscheduled reoperation
time frame: Day 30 after surgery
description: reoperation within 30 days after surgery
measure: Rate of unscheduled readmission
time frame: Day 30 after surgery
description: unscheduled readmission within 30 days after surgery
measure: R0 resection rate
time frame: immediately after the pathology report issued
description: R0 resection rate
measure: Proximal margin length
time frame: 30minutes after removal of tumor
description: from proximal tumor margin to proximal margin
measure: Local recurrence of lower mediastinal area in 3 years
time frame: Year 3 after surgery
description: Local recurrence of lower mediastinal area in 3 years
measure: Rate of cancer specific death in 3 years
time frame: Year 3 after surgery
description: Rate of cancer specific death in 3 years
measure: Recurrence free survival in 3 years
time frame: Year 3 after surgery
description: Recurrence free survival in 3 years
measure: Overall survival in 3 years
time frame: Year 3 after surgery
description: Overall survival in 3 years
measure: Quality evaluation index of Lower Mediastinal Lymphadenectomy
time frame: through study completion, an average of 3 years
description: surgical characteristics that are directly related to the safety outcome of surgery
measure: Learning curve of Lower Mediastinal Lymphadenectomy
time frame: through study completion, an average of 3 years
description: refers to the number of surgical cases corresponding to the transition point
measure: Treatment tendency of surgeons and patients
time frame: through study completion, an average of 3 years
description: the proportion of persons willing to receive treatment in randomization
measure: Number of patients that can be screened and successfully recruited
time frame: through study completion, an average of 3 years
description: The number of patients that can be screened, excluded, successfully recruited, intervented, and followed up throughout each phase of the study.
arm group label: Laparoscopic Surgery
description: Lower Mediastinal Lymphadenectomy should be finished via laparoscopic method.
arm group label: Open Surgery
description: Lower Mediastinal Lymphadenectomy should be finished via open method.
intervention type: Procedure
intervention name: Radical gastrectomy with dissection of lower mediastinal lymph node
description: Radical gastrectomy for gastric cancer should be consistent with Japanese gastric cancer treatment guideline.
arm group label: Laparoscopic Surgery
arm group label: Open Surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
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PMID: 26352529
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PMID: 31135850
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PMID: 32060757
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PMID: 27981384
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Jiafu Ji
investigator title: President of Beijing Cancer Hospital
mesh term: Stomach Neoplasms
sharing ipd: Yes
ipd description: De-identified data will be shared after the publication of the results.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After the publication.