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Front Oncol. 2023 Feb 23;13:1136834. doi: 10.3389/fonc.2023.1136834. eCollection 2023.

本文引用的文献

1
Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.《全球癌症统计数据 2020：全球 185 个国家和地区 36 种癌症的发病率和死亡率估计》。
CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
2
Japanese gastric cancer treatment guidelines 2018 (5th edition).《日本胃癌治疗指南2018（第5版）》
Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14.
3
Long-term oncological outcomes of laparoscopic versus open transhiatal resection for patients with Siewert type II adenocarcinoma of the esophagogastric junction.腹腔镜与开放经裂孔切除术治疗食管胃交界部Siewert II型腺癌患者的长期肿瘤学结局
Surg Endosc. 2021 Jan;35(1):340-348. doi: 10.1007/s00464-020-07406-w. Epub 2020 Feb 5.
4
Mapping of Lymph Node Metastasis From Esophagogastric Junction Tumors: A Prospective Nationwide Multicenter Study.胃食管结合部肿瘤淋巴结转移的定位：一项全国前瞻性多中心研究。
Ann Surg. 2021 Jul 1;274(1):120-127. doi: 10.1097/SLA.0000000000003499.
5
Clinical significance of esophageal invasion length for the prediction of mediastinal lymph node metastasis in Siewert type II adenocarcinoma: A retrospective single-institution study.食管浸润长度对Siewert II型腺癌纵隔淋巴结转移预测的临床意义：一项单机构回顾性研究。
Ann Gastroenterol Surg. 2018 Apr 10;2(3):187-196. doi: 10.1002/ags3.12069. eCollection 2018 May.
6
When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts.何时以及如何在随机临床试验中使用多重插补来处理缺失数据——附流程图的实用指南。
BMC Med Res Methodol. 2017 Dec 6;17(1):162. doi: 10.1186/s12874-017-0442-1.
7
Short-term outcomes after laparoscopic versus open transhiatal resection of Siewert type II adenocarcinoma of the esophagogastric junction.腹腔镜与开腹经食管裂孔入路手术治疗食管胃交界部 Siewert Ⅱ型腺癌的短期疗效比较。
Surg Endosc. 2018 Jan;32(1):383-390. doi: 10.1007/s00464-017-5687-6. Epub 2017 Jun 27.
8
Laparoscopic-assisted versus open total gastrectomy for Siewert type II and III esophagogastric junction carcinoma: a propensity score-matched case-control study.腹腔镜辅助与开腹全胃切除术治疗 Siewert Ⅱ型和Ⅲ型食管胃结合部腺癌的对比：一项倾向评分匹配的病例对照研究。
Surg Endosc. 2017 Sep;31(9):3495-3503. doi: 10.1007/s00464-016-5375-y. Epub 2016 Dec 15.
9
Changes of Esophagogastric Junctional Adenocarcinoma and Gastroesophageal Reflux Disease Among Surgical Patients During 1988-2012: A Single-institution, High-volume Experience in China.1988 - 2012年手术患者中食管胃交界腺癌和胃食管反流病的变化：中国一家高容量单机构经验
Ann Surg. 2016 Jan;263(1):88-95. doi: 10.1097/SLA.0000000000001148.
10
Ten-year follow-up results of a randomized clinical trial comparing left thoracoabdominal and abdominal transhiatal approaches to total gastrectomy for adenocarcinoma of the oesophagogastric junction or gastric cardia.一项随机临床试验的十年随访结果，该试验比较了左胸腹联合入路与经腹食管裂孔入路行食管胃交界部或贲门腺癌全胃切除术的疗效。
Br J Surg. 2015 Mar;102(4):341-8. doi: 10.1002/bjs.9764. Epub 2015 Jan 21.

腹腔镜与开放手术行胃食管交界部Siewert II/III型腺癌下纵隔淋巴结清扫术：一项探索性、观察性、前瞻性、IDEAL 2b期队列研究（CLASS-10研究）

Laparoscopic . 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).

作者信息

Li Shuangxi, Ying Xiangji, Shan Fei, Jia Yongning, Li Zhemin, Xue Kan, Miao Rulin, Wang Yinkui, Bu Zhaode, Su Xiangqian, Li Ziyu, Ji Jiafu

机构信息

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, Beijing 100142, China.

出版信息

Chin J Cancer Res. 2022 Aug 30;34(4):406-414. doi: 10.21147/j.issn.1000-9604.2022.04.08.

DOI:10.21147/j.issn.1000-9604.2022.04.08
PMID:36199536
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9468012/
Abstract

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).

摘要

目的

本研究旨在验证腹腔镜下纵隔下淋巴结清扫术治疗食管胃交界部（AEG）Siewert II/III型腺癌的可行性和疗效。

背景

将在理念、开发、探索、评估和长期随访（IDEAL）框架（2b期）下开展一项探索性、观察性、前瞻性队列研究。

参与者

本研究将招募1036例局部晚期AEG患者（Siewert II/III型，临床分期cT2-4aN0-3M0），其中518例将被分配至腹腔镜组或开放手术组。

干预措施

患者将接受纵隔下淋巴结清扫术及全胃或近端胃切除术。

主要和次要观察指标

主要终点是纵隔下淋巴结的获取数量，次要终点是手术安全性和预后，包括术中及术后与纵隔下淋巴结清扫术相关的发病率和死亡率、再入院率、R0切除率、3年局部复发率和3年总生存率。

结论

本研究将为AEG手术治疗策略的指导和发展提供数据。

试验注册号

本研究已在ClinicalTrials.gov注册（编号：NCT04443478）。