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. 2021 Feb 16;11(2):e038634.
doi: 10.1136/bmjopen-2020-038634.

Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study

Tai Ren  1   2 , Yongsheng Li  2   3 , Xi Zhang  4 , Yajun Geng  1   2 , Ziyu Shao  1   2 , Maolan Li  1   2 , Xiangsong Wu  1   2 , Xu-An Wang  2   3 , Fatao Liu  2 , Wenguang Wu  2   3 , Yijun Shu  1   2 , Runfa Bao  1   2 , Wei Gong  1   2 , Ping Dong  1   2 , Xueyi Dang  5 , Chang Liu  6 , Changjun Liu  7 , Bei Sun  8 , Jun Liu  9 , Lin Wang  10 , Defei Hong  11 , Renyi Qin  12 , Xiaoqing Jiang  13 , Xuewen Zhang  14 , Junmin Xu  15 , Jianguang Jia  16 , Bo Yang  17 , Bing Li  18 , Chaoliu Dai  19 , Jingyu Cao  20 , Hong Cao  21 , Feng Tao  22 , Zaiyang Zhang  23 , Yi Wang  24 , Huihan Jin  25 , Hongyu Cai  26 , Zhewei Fei  27 , Jianfeng Gu  28 , Wei Han  29 , Xuedong Feng  30 , Lu Fang  31 , Linhui Zheng  32 , Chunfu Zhu  33 , Kunhua Wang  34 , Xueli Zhang  35 , Xiaoyong Li  36 , Chong Jin  37 , Yeben Qian  38 , Yunfu Cui  39 , Yuzhen Xu  40 , Xiang Wang  41 , Houbao Liu  42 , Yawei Hua  43 , Chao Liu  44 , Jihui Hao  45 , Chuanlei Wang  46 , Qiyun Li  47 , Xun Li  48 , Jiansheng Liu  49 , Mingzhang Li  50 , Yudong Qiu  51 , Buqiang Wu  52 , Jinfang Zheng  53 , Xiaoliang Chen  54 , Haihong Zhu  55 , Kejun Hua  56 , Maolin Yan  57 , Peng Wang  58 , Hong Zang  59 , Xiaoming Ma  60 , Jian Hong  61 , Yingbin Liu  62   3
Affiliations

Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study

Tai Ren et al. BMJ Open. .

Abstract

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.

Keywords: hepatobiliary disease; oncology; surgery.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Workflow of data collection and quality control in CRGGC. CRGGC, Chinese Research Group of Gallbladder Cancer; GBC, gallbladder cancer.
See this image and copyright information in PMC

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