Shuangxi Li, Xiangji Ying, Fei Shan, Yongning Jia, Zhemin Li, Kan Xue, Rulin Miao, Yinkui Wang, Zhaode Bu, Xiangqian Su, Ziyu Li, Jiafu Ji
{"title":"腹腔镜与开放式下纵隔淋巴结切除术治疗食管胃交界Siewert II/III型腺癌:一项探索性、观察性、前瞻性、IDEAL 2b期队列研究(CLASS-10研究)。","authors":"Shuangxi Li, Xiangji Ying, Fei Shan, Yongning Jia, Zhemin Li, Kan Xue, Rulin Miao, Yinkui Wang, Zhaode Bu, Xiangqian Su, Ziyu Li, Jiafu Ji","doi":"10.21147/j.issn.1000-9604.2022.04.08","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This study aims to verify the feasibility and efficacy of laparoscopic lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction (AEG).</p><p><strong>Setting: </strong>An exploratory, observational, prospective, cohort study will be carried out under the Idea, Development, Exploration, Assessment and Long-term Follow-up (IDEAL) framework (stage 2b).</p><p><strong>Participants: </strong>The study will recruit 1,036 patients with cases of locally advanced AEG (Siewert type II/III, clinical stage cT2-4aN0-3M0), and 518 will be assigned to either the laparoscopy group or the open group.</p><p><strong>Interventions: </strong>Patients will receive lower mediastinal lymphadenectomy along with either total or proximal gastrectomy.</p><p><strong>Primary and secondary outcome measures: </strong>The primary endpoint is the number of lower mediastinal lymph nodes retrieved, and the secondary endpoints are the surgical safety and prognosis, including intraoperative and postoperative lower-mediastinal-lymphadenectomy-related morbidity and mortality, rate of rehospitalization, R0 resection rate, 3-year local recurrence rate, and 3-year overall survival.</p><p><strong>Conclusions: </strong>The study will provide data for the guidance and development of surgical treatment strategies for AEG.</p><p><strong>Trial registration number: </strong>The study has been registered in ClinicalTrials.gov (No. NCT04443478).</p>","PeriodicalId":9830,"journal":{"name":"Chinese journal of cancer research = Chung-kuo yen cheng yen chiu","volume":"34 4","pages":"406-414"},"PeriodicalIF":0.0000,"publicationDate":"2022-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9468012/pdf/cjcr-34-4-406.pdf","citationCount":"1","resultStr":"{\"title\":\"Laparoscopic <i>vs</i>. open lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction: An exploratory, observational, prospective, IDEAL stage 2b cohort study (CLASS-10 study).\",\"authors\":\"Shuangxi Li, Xiangji Ying, Fei Shan, Yongning Jia, Zhemin Li, Kan Xue, Rulin Miao, Yinkui Wang, Zhaode Bu, Xiangqian Su, Ziyu Li, Jiafu Ji\",\"doi\":\"10.21147/j.issn.1000-9604.2022.04.08\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This study aims to verify the feasibility and efficacy of laparoscopic lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction (AEG).</p><p><strong>Setting: </strong>An exploratory, observational, prospective, cohort study will be carried out under the Idea, Development, Exploration, Assessment and Long-term Follow-up (IDEAL) framework (stage 2b).</p><p><strong>Participants: </strong>The study will recruit 1,036 patients with cases of locally advanced AEG (Siewert type II/III, clinical stage cT2-4aN0-3M0), and 518 will be assigned to either the laparoscopy group or the open group.</p><p><strong>Interventions: </strong>Patients will receive lower mediastinal lymphadenectomy along with either total or proximal gastrectomy.</p><p><strong>Primary and secondary outcome measures: </strong>The primary endpoint is the number of lower mediastinal lymph nodes retrieved, and the secondary endpoints are the surgical safety and prognosis, including intraoperative and postoperative lower-mediastinal-lymphadenectomy-related morbidity and mortality, rate of rehospitalization, R0 resection rate, 3-year local recurrence rate, and 3-year overall survival.</p><p><strong>Conclusions: </strong>The study will provide data for the guidance and development of surgical treatment strategies for AEG.</p><p><strong>Trial registration number: </strong>The study has been registered in ClinicalTrials.gov (No. NCT04443478).</p>\",\"PeriodicalId\":9830,\"journal\":{\"name\":\"Chinese journal of cancer research = Chung-kuo yen cheng yen chiu\",\"volume\":\"34 4\",\"pages\":\"406-414\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-08-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9468012/pdf/cjcr-34-4-406.pdf\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Chinese journal of cancer research = Chung-kuo yen cheng yen 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Laparoscopic vs. open lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction: An exploratory, observational, prospective, IDEAL stage 2b cohort study (CLASS-10 study).
Objective: This study aims to verify the feasibility and efficacy of laparoscopic lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction (AEG).
Setting: An exploratory, observational, prospective, cohort study will be carried out under the Idea, Development, Exploration, Assessment and Long-term Follow-up (IDEAL) framework (stage 2b).
Participants: The study will recruit 1,036 patients with cases of locally advanced AEG (Siewert type II/III, clinical stage cT2-4aN0-3M0), and 518 will be assigned to either the laparoscopy group or the open group.
Interventions: Patients will receive lower mediastinal lymphadenectomy along with either total or proximal gastrectomy.
Primary and secondary outcome measures: The primary endpoint is the number of lower mediastinal lymph nodes retrieved, and the secondary endpoints are the surgical safety and prognosis, including intraoperative and postoperative lower-mediastinal-lymphadenectomy-related morbidity and mortality, rate of rehospitalization, R0 resection rate, 3-year local recurrence rate, and 3-year overall survival.
Conclusions: The study will provide data for the guidance and development of surgical treatment strategies for AEG.
Trial registration number: The study has been registered in ClinicalTrials.gov (No. NCT04443478).
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