Protocol for expanded indications of endoscopic submucosal dissection for early gastric cancer in China: a multicenter,
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Protocol for expanded indications of endoscopic submucosal dissection for early gastric cancer in China: a multicenter, ambispective, observational, open-cohort study Zhi Zheng1,2,3,4†, Jie Yin1,2,3,4†, Ziyu Li5, Yingjiang Ye6, Bo Wei7, Xin Wang8, Yantao Tian9, Mengyi Li1,2,3,4, Qian Zhang3,5, Na Zeng3,10, Rui Xu3,11, Guangyong Chen3,7, Jie Zhang12, Peng Li3,4,13, Jun Cai1,2,3,4, Hongwei Yao1,2,3,4, Jun Zhang1,2,3,4* , Zhongtao Zhang1,2,3,4 and Shutian Zhang3,4,13
Abstract Background: The main treatment methods for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications for ESD remains unestablished. In China, evidence-based medicine for the expanding indications of ESD and accurate diagnostic staging for EGC patients are lacking. Thus, clinical studies involving Chinese patients with EGC are necessary to select appropriate treatment options and promote China’s expanded indications for ESD and diagnostic staging scheme. Methods: This is a multicenter, ambispective, observational, open-cohort study that is expected to enroll 554 patients with EGC. The study was launched in May 2018 and is scheduled to end in March 2022. All enrolled patients should meet the inclusion criteria. Case report forms and electronic data capture systems are used to obtain clinical data, which includes demographic information, results of perioperative blood- and auxiliary examinations, surgical information, results of postoperative pathology, and the outcomes of postoperative recovery and follow-up. Patients are followed up every 6 months after surgery for a minimum of 5 years. The primary endpoint is the rate of lymph node metastasis (LNM), whereas the secondary endpoints include the following: consistency, sensitivity, and specificity of the results of preoperative examinations and postoperative pathology; cutoff values for LNM; logistic regression model of expanded indications for ESD; and incidence of postoperative complications within the 30-day and 5-year relapse-free survival rates. (Continued on next page)
* Correspondence: [email protected] † Zhi Zheng and Jie Yin contributed equally to this work. 1 Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing 100050, China 2 Beijing Key Laboratory of Cancer Invasion and Metastasis Research, Beijing, China Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons li
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