BMJ Open (Feb 2021)

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

  • Xun Li,
  • Bo Yang,
  • Hong Cao,
  • Tai Ren,
  • Yongsheng Li,
  • Yajun Geng,
  • Ziyu Shao,
  • Xiangsong Wu,
  • Xu-An Wang,
  • Wenguang Wu,
  • Yijun Shu,
  • Runfa Bao,
  • Ping Dong,
  • Xueyi Dang,
  • Changjun Liu,
  • Defei Hong,
  • Xuewen Zhang,
  • Junmin Xu,
  • Jianguang Jia,
  • Chaoliu Dai,
  • Jingyu Cao,
  • Feng Tao,
  • Zaiyang Zhang,
  • Huihan Jin,
  • Hongyu Cai,
  • Zhewei Fei,
  • Jianfeng Gu,
  • Xuedong Feng,
  • Linhui Zheng,
  • Chunfu Zhu,
  • Kunhua Wang,
  • Xiaoyong Li,
  • Chong Jin,
  • Yeben Qian,
  • Yunfu Cui,
  • Yuzhen Xu,
  • Yawei Hua,
  • Chuanlei Wang,
  • Qiyun Li,
  • Jiansheng Liu,
  • Mingzhang Li,
  • Yudong Qiu,
  • Buqiang Wu,
  • Jinfang Zheng,
  • Haihong Zhu,
  • Kejun Hua,
  • Maolin Yan,
  • Hong Zang,
  • Xiaoming Ma,
  • Jian Hong

DOI
https://doi.org/10.1136/bmjopen-2020-038634
Journal volume & issue
Vol. 11, no. 2

Abstract

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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.