<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/NCT03273920</url>
  </required_header>
  <id_info>
    <org_study_id>CRASS-01</org_study_id>
    <nct_id>NCT03273920</nct_id>
  </id_info>
  <brief_title>Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer</brief_title>
  <official_title>Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer: a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southwest Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xijing Hospital of Digestive Diseases</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanjing PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qingdao University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Medical University Union Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jilin Provincial Tumor Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lanzhou General Hospital of PLA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Southwest Hospital, China</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>
      This study is an investigator-initiated, randomized, controlled, parallel group, and&#xD;
      non-inferiority trial comparing robot-assisted gastrectomy with D2 nodal dissection for&#xD;
      locally advanced gastric cancer patients with laparoscopic procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the first case of laparoscopy-assisted distal gastrectomy was reported in 1994, the&#xD;
      number of patients undergoing the laparoscopic procedure has gradually increased. The latest&#xD;
      Japanese gastric cancer treatment guideline recommends laparoscopic gastrectomy (LG) as an&#xD;
      optional treatment for cStage I gastric cancer (GC). Based on the experience of early GC,&#xD;
      most experienced surgeons have applied the laparoscopic procedure in patients with locally&#xD;
      advanced gastric cancer (AGC). According to the results of large-scaled retrospective studies&#xD;
      and ongoing randomized controlled trials (RCTs), LG treating AGC can gain better short-term&#xD;
      outcomes and comparable long-term oncologic results.&#xD;
&#xD;
      To minimize the limitations of laparoscopic surgery, robot systems have been introduced to&#xD;
      treat GC providing technical advantages. Though the feasibility and safety of robotic&#xD;
      gastrectomy (RG) have been well accepted, the benefits of RG remain controversial. A recent&#xD;
      meta-analysis including eleven studies of 3503 patients demonstrated that RG indicated&#xD;
      potentially favorable outcomes in terms of blood loss compared with LG. Furthermore, it has&#xD;
      been confirmed that robotic system could provide an advantage over LG in the dissection of&#xD;
      the N2 area lymph nodes, especially around the splenic artery area. Our previous study&#xD;
      demonstrated that the RG had less intraoperative blood loss and more lymph nodes dissection&#xD;
      compared with the laparoscopic procedure. However, the only prospective study reported that&#xD;
      RG is not superior to LG in terms of perioperative surgical outcomes. Nevertheless, the&#xD;
      following subgroup analysis found that patients with GC undergoing D2 lymph node dissection&#xD;
      can benefit from less blood loss when a robotic surgery system is used. Take together, RG&#xD;
      with D2 nodal dissection may be superior laparoscopic surgery in terms of blood loss and&#xD;
      retrieved lymph nodes. However, lack of high-level evidence-based medical researches, we&#xD;
      can't drew a conclusion that patients with AGC may benefit from RG with D2 nodal dissection.&#xD;
&#xD;
      With regard to a new surgical approach, oncologic safety has attracted more attention.&#xD;
      Although some retrospective studies have demonstrated that RG with lymphadenectomy for GC had&#xD;
      non-inferior oncologic outcome relative to LG, there is no prospective RCT to evaluate the&#xD;
      long-term outcomes of RG. Therefore, the Chinese Robotic Gastrointestinal Surgery Study&#xD;
      (CRASS) Group launched a multicenter prospective RCT to verify the short-term and long-term&#xD;
      outcomes of RG in AGC. The primary objective of this study is to assess whether&#xD;
      robot-assisted distal gastrectomy is comparable to laparoscopic approach in terms of&#xD;
      long-term oncologic outcomes without compromising relapse-free survival. The secondary&#xD;
      research objectives are to compare robotic and laparoscopic approach in terms of morbidity,&#xD;
      mortality, quality of life, cost-effectiveness, and overall survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 25, 2017</start_date>
  <completion_date type="Anticipated">September 25, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 25, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-year relapse-free survival</measure>
    <time_frame>3 years</time_frame>
    <description>Relapse-free survival is defined as days from surgery to recurrence or death from any cause, and it is censored at the latest day when the patient is alive without any evidence of recurrence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>30 days</time_frame>
    <description>Early postoperative morbidity confined to events that occur within 30 days after surgery. The complications that occur after postoperative day 30 belong to late postoperative morbidity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Postoperative mortality is defined to death that occurs within 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year overall survival</measure>
    <time_frame>3 years</time_frame>
    <description>Overall survival is defined as days from surgery to death from any cause, and it is censored at the last day when the patient was alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year recurrence pattern</measure>
    <time_frame>3 years</time_frame>
    <description>Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative recovery course</measure>
    <time_frame>15 days</time_frame>
    <description>Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recovery course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory response</measure>
    <time_frame>7 days</time_frame>
    <description>The daily highest body temperature before discharge and the values of white blood cell count (10^9/L), hemoglobin (g/L), C-reactive protein (mg/L) and prealbumin (mg/L) from peripheral blood before operation and on postoperative day 1, 3, 5, 7 are recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune response</measure>
    <time_frame>7 days</time_frame>
    <description>The values of relevant immune cytokines from peripheral blood before operation and on postoperative day 1, 3, 5, 7 are recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1110</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Robotic gastrectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Robotic distal gastrectomy with D2 nodal dissection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic gastrectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic distal gastrectomy with D2 nodal dissection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robotic distal gastrectomy with D2 nodal dissection</intervention_name>
    <description>After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, robotic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.</description>
    <arm_group_label>Robotic gastrectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic distal gastrectomy with D2 nodal dissection</intervention_name>
    <description>After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.</description>
    <arm_group_label>Laparoscopic gastrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pathologically proven gastric adenocarcinoma.&#xD;
&#xD;
          2. Tumor located in the lower third of the stomach, and is possible to be curatively&#xD;
             resected by subtotal gastrectomy.&#xD;
&#xD;
          3. Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on&#xD;
             Cancer/Union for International Cancer Control 8th edition&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          5. American Society of Anesthesiology (ASA) score of class I to III&#xD;
&#xD;
          6. Patients who freely give informed consent to participate in the clinical study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous upper abdominal surgery (except laparoscopic cholecystectomy)&#xD;
&#xD;
          2. Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic&#xD;
             submucosal dissection)&#xD;
&#xD;
          3. Gastric cancer-related complications (complete obstruction or perforation)&#xD;
&#xD;
          4. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative&#xD;
             imaging&#xD;
&#xD;
          5. Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer&#xD;
&#xD;
          6. Patients diagnosed with other malignancy within 5 years&#xD;
&#xD;
          7. Severe mental disorder&#xD;
&#xD;
          8. Unstable angina or myocardial infarction within the past 6 months&#xD;
&#xD;
          9. Cerebrovascular accident within the past 6 months&#xD;
&#xD;
         10. Severe respiratory disease (FEV1&lt; 50%)&#xD;
&#xD;
         11. Continuous systemic steroid therapy within 1 month before the study&#xD;
&#xD;
         12. Pregnant or breast-feeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peiwu Yu, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Southwest Hospital, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peiwu Yu, M.D.</last_name>
    <phone>+86023-68754161</phone>
    <email>yupeiwu01@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA general hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Lin Chen, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xiangqian Su, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yu Pei Wu, M.D.</last_name>
      <phone>008602368754146</phone>
      <email>yupeiwu01@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Shi Yan, M.D.</last_name>
      <phone>008602368765267</phone>
      <email>shiyandoctor@sina.com</email>
    </contact_backup>
    <investigator>
      <last_name>Pei Wu Yu, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yan Shi, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Changmin Huang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lanzhou PLA General Hospital</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Hongbin Liu, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Zhiwei Zhou, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Kaixiong Tao, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Hongliang Yao, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nanjing General Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Zhiwei Jiang, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Taiyuan Li, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Longwei Cheng, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yanbing Zhou, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital of Digestive Dieases</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jipeng Li, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jiankun Hu, M.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <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>Zhao Y, Yu P, Hao Y, Qian F, Tang B, Shi Y, Luo H, Zhang Y. Comparison of outcomes for laparoscopically assisted and open radical distal gastrectomy with lymphadenectomy for advanced gastric cancer. Surg Endosc. 2011 Sep;25(9):2960-6. doi: 10.1007/s00464-011-1652-y. Epub 2011 Apr 22.</citation>
    <PMID>21512884</PMID>
  </reference>
  <reference>
    <citation>Hu Y, Ying M, Huang C, Wei H, Jiang Z, Peng X, Hu J, Du X, Wang B, Lin F, Xu J, Dong G, Mou T, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Oncologic outcomes of laparoscopy-assisted gastrectomy for advanced gastric cancer: a large-scale multicenter retrospective cohort study from China. Surg Endosc. 2014 Jul;28(7):2048-56. doi: 10.1007/s00464-014-3426-9. Epub 2014 Mar 21.</citation>
    <PMID>24651893</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>Inaki N, Etoh T, Ohyama T, Uchiyama K, Katada N, Koeda K, Yoshida K, Takagane A, Kojima K, Sakuramoto S, Shiraishi N, Kitano S. A Multi-institutional, Prospective, Phase II Feasibility Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (JLSSG0901). World J Surg. 2015 Nov;39(11):2734-41. doi: 10.1007/s00268-015-3160-z.</citation>
    <PMID>26170158</PMID>
  </reference>
  <reference>
    <citation>Hashizume M, Shimada M, Tomikawa M, Ikeda Y, Takahashi I, Abe R, Koga F, Gotoh N, Konishi K, Maehara S, Sugimachi K. Early experiences of endoscopic procedures in general surgery assisted by a computer-enhanced surgical system. Surg Endosc. 2002 Aug;16(8):1187-91. doi: 10.1007/s004640080154. Epub 2002 May 3.</citation>
    <PMID>11984681</PMID>
  </reference>
  <reference>
    <citation>Junfeng Z, Yan S, Bo T, Yingxue H, Dongzhu Z, Yongliang Z, Feng Q, Peiwu Y. Robotic gastrectomy versus laparoscopic gastrectomy for gastric cancer: comparison of surgical performance and short-term outcomes. Surg Endosc. 2014 Jun;28(6):1779-87. doi: 10.1007/s00464-013-3385-6. Epub 2014 Jan 3.</citation>
    <PMID>24385251</PMID>
  </reference>
  <reference>
    <citation>Nakauchi M, Suda K, Susumu S, Kadoya S, Inaba K, Ishida Y, Uyama I. Comparison of the long-term outcomes of robotic radical gastrectomy for gastric cancer and conventional laparoscopic approach: a single institutional retrospective cohort study. Surg Endosc. 2016 Dec;30(12):5444-5452. doi: 10.1007/s00464-016-4904-z. Epub 2016 Apr 29.</citation>
    <PMID>27129542</PMID>
  </reference>
  <reference>
    <citation>Obama K, Kim YM, Kang DR, Son T, Kim HI, Noh SH, Hyung WJ. Long-term oncologic outcomes of robotic gastrectomy for gastric cancer compared with laparoscopic gastrectomy. Gastric Cancer. 2018 Mar;21(2):285-295. doi: 10.1007/s10120-017-0740-7. Epub 2017 Jun 21.</citation>
    <PMID>28639136</PMID>
  </reference>
  <reference>
    <citation>Duan BS, Zhao J, Xie LF, Wang Y. Robotic Verse Laparoscopic Gastrectomy for Gastric Cancer: A Pooled Analysis of 11 Individual Studies. Surg Laparosc Endosc Percutan Tech. 2017 Jun;27(3):147-153. doi: 10.1097/SLE.0000000000000410.</citation>
    <PMID>28582378</PMID>
  </reference>
  <reference>
    <citation>Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, Ryu KW, Park JM, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Kim YN, Hyung WJ. Multicenter Prospective Comparative Study of Robotic Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma. Ann Surg. 2016 Jan;263(1):103-9. doi: 10.1097/SLA.0000000000001249.</citation>
    <PMID>26020107</PMID>
  </reference>
  <reference>
    <citation>Park JM, Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Hyung WJ, Ryu KW. Who may benefit from robotic gastrectomy?: A subgroup analysis of multicenter prospective comparative study data on robotic versus laparoscopic gastrectomy. Eur J Surg Oncol. 2016 Dec;42(12):1944-1949. doi: 10.1016/j.ejso.2016.07.012. Epub 2016 Jul 29.</citation>
    <PMID>27514719</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southwest Hospital, China</investigator_affiliation>
    <investigator_full_name>Yan Shi</investigator_full_name>
    <investigator_title>Deputy director</investigator_title>
  </responsible_party>
  <keyword>laparoscopy-assisted gastrectomy</keyword>
  <keyword>robot-assisted gastrectomy</keyword>
  <keyword>advanced gastric cancer</keyword>
  <keyword>D2 Lymphadenectomy</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>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/NCT03273920
org study id: CRASS-01
nct id: NCT03273920
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is an investigator-initiated, randomized, controlled, parallel group, and
      non-inferiority trial comparing robot-assisted gastrectomy with D2 nodal dissection for
      locally advanced gastric cancer patients with laparoscopic procedure.
Since the first case of laparoscopy-assisted distal gastrectomy was reported in 1994, the
      number of patients undergoing the laparoscopic procedure has gradually increased. The latest
      Japanese gastric cancer treatment guideline recommends laparoscopic gastrectomy (LG) as an
      optional treatment for cStage I gastric cancer (GC). Based on the experience of early GC,
      most experienced surgeons have applied the laparoscopic procedure in patients with locally
      advanced gastric cancer (AGC). According to the results of large-scaled retrospective studies
      and ongoing randomized controlled trials (RCTs), LG treating AGC can gain better short-term
      outcomes and comparable long-term oncologic results.

      To minimize the limitations of laparoscopic surgery, robot systems have been introduced to
      treat GC providing technical advantages. Though the feasibility and safety of robotic
      gastrectomy (RG) have been well accepted, the benefits of RG remain controversial. A recent
      meta-analysis including eleven studies of 3503 patients demonstrated that RG indicated
      potentially favorable outcomes in terms of blood loss compared with LG. Furthermore, it has
      been confirmed that robotic system could provide an advantage over LG in the dissection of
      the N2 area lymph nodes, especially around the splenic artery area. Our previous study
      demonstrated that the RG had less intraoperative blood loss and more lymph nodes dissection
      compared with the laparoscopic procedure. However, the only prospective study reported that
      RG is not superior to LG in terms of perioperative surgical outcomes. Nevertheless, the
      following subgroup analysis found that patients with GC undergoing D2 lymph node dissection
      can benefit from less blood loss when a robotic surgery system is used. Take together, RG
      with D2 nodal dissection may be superior laparoscopic surgery in terms of blood loss and
      retrieved lymph nodes. However, lack of high-level evidence-based medical researches, we
      can't drew a conclusion that patients with AGC may benefit from RG with D2 nodal dissection.

      With regard to a new surgical approach, oncologic safety has attracted more attention.
      Although some retrospective studies have demonstrated that RG with lymphadenectomy for GC had
      non-inferior oncologic outcome relative to LG, there is no prospective RCT to evaluate the
      long-term outcomes of RG. Therefore, the Chinese Robotic Gastrointestinal Surgery Study
      (CRASS) Group launched a multicenter prospective RCT to verify the short-term and long-term
      outcomes of RG in AGC. The primary objective of this study is to assess whether
      robot-assisted distal gastrectomy is comparable to laparoscopic approach in terms of
      long-term oncologic outcomes without compromising relapse-free survival. The secondary
      research objectives are to compare robotic and laparoscopic approach in terms of morbidity,
      mortality, quality of life, cost-effectiveness, and overall survival.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3-year relapse-free survival
time frame: 3 years
description: Relapse-free survival is defined as days from surgery to recurrence or death from any cause, and it is censored at the latest day when the patient is alive without any evidence of recurrence.
measure: Morbidity
time frame: 30 days
description: Early postoperative morbidity confined to events that occur within 30 days after surgery. The complications that occur after postoperative day 30 belong to late postoperative morbidity
measure: Mortality
time frame: 30 days
description: Postoperative mortality is defined to death that occurs within 30 days.
measure: 3-year overall survival
time frame: 3 years
description: Overall survival is defined as days from surgery to death from any cause, and it is censored at the last day when the patient was alive.
measure: 3-year recurrence pattern
time frame: 3 years
description: Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
measure: Postoperative recovery course
time frame: 15 days
description: Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recovery course.
measure: Inflammatory response
time frame: 7 days
description: The daily highest body temperature before discharge and the values of white blood cell count (10^9/L), hemoglobin (g/L), C-reactive protein (mg/L) and prealbumin (mg/L) from peripheral blood before operation and on postoperative day 1, 3, 5, 7 are recorded.
measure: Immune response
time frame: 7 days
description: The values of relevant immune cytokines from peripheral blood before operation and on postoperative day 1, 3, 5, 7 are recorded.
arm group label: Robotic gastrectomy
arm group type: Experimental
description: Robotic distal gastrectomy with D2 nodal dissection
arm group label: Laparoscopic gastrectomy
arm group type: Active Comparator
description: Laparoscopic distal gastrectomy with D2 nodal dissection
intervention type: Procedure
intervention name: Robotic distal gastrectomy with D2 nodal dissection
description: After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, robotic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
arm group label: Robotic gastrectomy
intervention type: Procedure
intervention name: Laparoscopic distal gastrectomy with D2 nodal dissection
description: After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
arm group label: Laparoscopic gastrectomy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Peiwu Yu, M.D.
role: Study Chair
affiliation: Southwest Hospital, China
last name: Peiwu Yu, M.D.
phone: +86023-68754161
email: yupeiwu01@sina.com
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
country: China
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.
PMID: 8180768
citation: Zhao Y, Yu P, Hao Y, Qian F, Tang B, Shi Y, Luo H, Zhang Y. Comparison of outcomes for laparoscopically assisted and open radical distal gastrectomy with lymphadenectomy for advanced gastric cancer. Surg Endosc. 2011 Sep;25(9):2960-6. doi: 10.1007/s00464-011-1652-y. Epub 2011 Apr 22.
PMID: 21512884
citation: Hu Y, Ying M, Huang C, Wei H, Jiang Z, Peng X, Hu J, Du X, Wang B, Lin F, Xu J, Dong G, Mou T, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Oncologic outcomes of laparoscopy-assisted gastrectomy for advanced gastric cancer: a large-scale multicenter retrospective cohort study from China. Surg Endosc. 2014 Jul;28(7):2048-56. doi: 10.1007/s00464-014-3426-9. Epub 2014 Mar 21.
PMID: 24651893
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.
PMID: 26903580
citation: Inaki N, Etoh T, Ohyama T, Uchiyama K, Katada N, Koeda K, Yoshida K, Takagane A, Kojima K, Sakuramoto S, Shiraishi N, Kitano S. A Multi-institutional, Prospective, Phase II Feasibility Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (JLSSG0901). World J Surg. 2015 Nov;39(11):2734-41. doi: 10.1007/s00268-015-3160-z.
PMID: 26170158
citation: Hashizume M, Shimada M, Tomikawa M, Ikeda Y, Takahashi I, Abe R, Koga F, Gotoh N, Konishi K, Maehara S, Sugimachi K. Early experiences of endoscopic procedures in general surgery assisted by a computer-enhanced surgical system. Surg Endosc. 2002 Aug;16(8):1187-91. doi: 10.1007/s004640080154. Epub 2002 May 3.
PMID: 11984681
citation: Junfeng Z, Yan S, Bo T, Yingxue H, Dongzhu Z, Yongliang Z, Feng Q, Peiwu Y. Robotic gastrectomy versus laparoscopic gastrectomy for gastric cancer: comparison of surgical performance and short-term outcomes. Surg Endosc. 2014 Jun;28(6):1779-87. doi: 10.1007/s00464-013-3385-6. Epub 2014 Jan 3.
PMID: 24385251
citation: Nakauchi M, Suda K, Susumu S, Kadoya S, Inaba K, Ishida Y, Uyama I. Comparison of the long-term outcomes of robotic radical gastrectomy for gastric cancer and conventional laparoscopic approach: a single institutional retrospective cohort study. Surg Endosc. 2016 Dec;30(12):5444-5452. doi: 10.1007/s00464-016-4904-z. Epub 2016 Apr 29.
PMID: 27129542
citation: Obama K, Kim YM, Kang DR, Son T, Kim HI, Noh SH, Hyung WJ. Long-term oncologic outcomes of robotic gastrectomy for gastric cancer compared with laparoscopic gastrectomy. Gastric Cancer. 2018 Mar;21(2):285-295. doi: 10.1007/s10120-017-0740-7. Epub 2017 Jun 21.
PMID: 28639136
citation: Duan BS, Zhao J, Xie LF, Wang Y. Robotic Verse Laparoscopic Gastrectomy for Gastric Cancer: A Pooled Analysis of 11 Individual Studies. Surg Laparosc Endosc Percutan Tech. 2017 Jun;27(3):147-153. doi: 10.1097/SLE.0000000000000410.
PMID: 28582378
citation: Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, Ryu KW, Park JM, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Kim YN, Hyung WJ. Multicenter Prospective Comparative Study of Robotic Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma. Ann Surg. 2016 Jan;263(1):103-9. doi: 10.1097/SLA.0000000000001249.
PMID: 26020107
citation: Park JM, Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Hyung WJ, Ryu KW. Who may benefit from robotic gastrectomy?: A subgroup analysis of multicenter prospective comparative study data on robotic versus laparoscopic gastrectomy. Eur J Surg Oncol. 2016 Dec;42(12):1944-1949. doi: 10.1016/j.ejso.2016.07.012. Epub 2016 Jul 29.
PMID: 27514719
responsible party type: Principal Investigator
investigator affiliation: Southwest Hospital, China
investigator full name: Yan Shi
investigator title: Deputy director
mesh term: Stomach Neoplasms
sharing ipd: No