中国胆囊癌登记研究方案：中国胆囊癌研究组（CRGGC）研究
Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study.
作者信息
Ren Tai, Li Yongsheng, Zhang Xi, Geng Yajun, Shao Ziyu, Li Maolan, Wu Xiangsong, Wang Xu-An, Liu Fatao, Wu Wenguang, Shu Yijun, Bao Runfa, Gong Wei, Dong Ping, Dang Xueyi, Liu Chang, Liu Changjun, Sun Bei, Liu Jun, Wang Lin, Hong Defei, Qin Renyi, Jiang Xiaoqing, Zhang Xuewen, Xu Junmin, Jia Jianguang, Yang Bo, Li Bing, Dai Chaoliu, Cao Jingyu, Cao Hong, Tao Feng, Zhang Zaiyang, Wang Yi, Jin Huihan, Cai Hongyu, Fei Zhewei, Gu Jianfeng, Han Wei, Feng Xuedong, Fang Lu, Zheng Linhui, Zhu Chunfu, Wang Kunhua, Zhang Xueli, Li Xiaoyong, Jin Chong, Qian Yeben, Cui Yunfu, Xu Yuzhen, Wang Xiang, Liu Houbao, Hua Yawei, Liu Chao, Hao Jihui, Wang Chuanlei, Li Qiyun, Li Xun, Liu Jiansheng, Li Mingzhang, Qiu Yudong, Wu Buqiang, Zheng Jinfang, Chen Xiaoliang, Zhu Haihong, Hua Kejun, Yan Maolin, Wang Peng, Zang Hong, Ma Xiaoming, Hong Jian, Liu Yingbin
机构信息
Department of General Surgery, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
Shanghai Key Laboratory of Biliary Tract Disease Research, Shanghai, China.
出版信息
BMJ Open. 2021 Feb 16;11(2):e038634. doi: 10.1136/bmjopen-2020-038634.
INTRODUCTION
Gallbladder cancer (GBC), the sixth most common gastrointestinal tract cancer, poses a significant disease burden in China. However, no national representative data are available on the clinical characteristics, treatment and prognosis of GBC in the Chinese population.
METHODS AND ANALYSIS
The Chinese Research Group of Gallbladder Cancer (CRGGC) study is a multicentre retrospective registry cohort study. Clinically diagnosed patient with GBC will be identified from 1 January 2008 to December, 2019, by reviewing the electronic medical records from 76 tertiary and secondary hospitals across 28 provinces in China. Patients with pathological and radiological diagnoses of malignancy, including cancer in situ, from the gallbladder and cystic duct are eligible, according to the National Comprehensive Cancer Network 2019 guidelines. Patients will be excluded if GBC is the secondary diagnosis in the discharge summary. The demographic characteristics, medical history, physical examination results, surgery information, pathological data, laboratory examination results and radiology reports will be collected in a standardised case report form. By May 2021, approximately 6000 patient with GBC will be included. The clinical follow-up data will be updated until 5 years after the last admission for GBC of each patient. The study aimed (1) to depict the clinical characteristics, including demographics, pathology, treatment and prognosis of patient with GBC in China; (2) to evaluate the adherence to clinical guidelines of GBC and (3) to improve clinical practice for diagnosing and treating GBC and provide references for policy-makers.
ETHICS AND DISSEMINATION
The protocol of the CRGGC has been approved by the Committee for Ethics of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (SHEC-C-2019-085). All results of this study will be published in peer-reviewed journals and presented at relevant conferences.
TRIAL REGISTRATION NUMBER
NCT04140552, Pre-results.
引言
胆囊癌（GBC）是第六大常见的胃肠道癌症，在中国造成了重大的疾病负担。然而，目前尚无关于中国人群中胆囊癌的临床特征、治疗和预后的全国代表性数据。
方法与分析
中国胆囊癌研究组（CRGGC）研究是一项多中心回顾性注册队列研究。通过查阅中国28个省份76家三级和二级医院的电子病历，从2008年1月1日至2019年12月，识别临床诊断为胆囊癌的患者。根据2019年美国国立综合癌症网络指南，病理和影像学诊断为恶性肿瘤（包括原位癌）的胆囊和胆囊管患者符合条件。如果胆囊癌是出院小结中的次要诊断，则将患者排除。将通过标准化病例报告表收集人口统计学特征、病史、体格检查结果、手术信息、病理数据、实验室检查结果和放射学报告。到2021年5月，预计将纳入约6000例胆囊癌患者。临床随访数据将更新至每位患者最后一次因胆囊癌入院后5年。该研究旨在：（1）描述中国胆囊癌患者的临床特征，包括人口统计学、病理学、治疗和预后；（2）评估对胆囊癌临床指南的遵循情况；（3）改善胆囊癌的诊断和治疗临床实践，并为政策制定者提供参考。
伦理与传播
CRGGC的方案已获得上海交通大学医学院新华医院伦理委员会（SHEC-C-2019-085）的批准。本研究的所有结果将发表在同行评审期刊上，并在相关会议上展示。
试验注册号
NCT04140552，预结果。
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