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

Tai Ren, Yongsheng Li, Xi Zhang, Yajun Geng, Ziyu Shao, Maolan Li, Xiangsong Wu, Xu-An Wang, Fatao Liu, Wenguang Wu, Yijun Shu, Runfa Bao, Wei Gong, Ping Dong, Xueyi Dang, Chang Liu, Changjun Liu, Bei Sun, Jun Liu, Lin Wang, Defei Hong, Renyi Qin, Xiaoqing Jiang, Xuewen Zhang, Junmin Xu, Jianguang Jia, Bo Yang, Bing Li, Chaoliu Dai, Jingyu Cao, Hong Cao, Feng Tao, Zaiyang Zhang, Yi Wang, Huihan Jin, Hongyu Cai, Zhewei Fei, Jianfeng Gu, Wei Han, Xuedong Feng, Lu Fang, Linhui Zheng, Chunfu Zhu, Kunhua Wang, Xueli Zhang, Xiaoyong Li, Chong Jin, Yeben Qian, Yunfu Cui, Yuzhen Xu, Xiang Wang, Houbao Liu, Yawei Hua, Chao Liu, Jihui Hao, Chuanlei Wang, Qiyun Li, Xun Li, Jiansheng Liu, Mingzhang Li, Yudong Qiu, Buqiang Wu, Jinfang Zheng, Xiaoliang Chen, Haihong Zhu, Kejun Hua, Maolin Yan, Peng Wang, Hong Zang, Xiaoming Ma, Jian Hong, Yingbin Liu, Tai Ren, Yongsheng Li, Xi Zhang, Yajun Geng, Ziyu Shao, Maolan Li, Xiangsong Wu, Xu-An Wang, Fatao Liu, Wenguang Wu, Yijun Shu, Runfa Bao, Wei Gong, Ping Dong, Xueyi Dang, Chang Liu, Changjun Liu, Bei Sun, Jun Liu, Lin Wang, Defei Hong, Renyi Qin, Xiaoqing Jiang, Xuewen Zhang, Junmin Xu, Jianguang Jia, Bo Yang, Bing Li, Chaoliu Dai, Jingyu Cao, Hong Cao, Feng Tao, Zaiyang Zhang, Yi Wang, Huihan Jin, Hongyu Cai, Zhewei Fei, Jianfeng Gu, Wei Han, Xuedong Feng, Lu Fang, Linhui Zheng, Chunfu Zhu, Kunhua Wang, Xueli Zhang, Xiaoyong Li, Chong Jin, Yeben Qian, Yunfu Cui, Yuzhen Xu, Xiang Wang, Houbao Liu, Yawei Hua, Chao Liu, Jihui Hao, Chuanlei Wang, Qiyun Li, Xun Li, Jiansheng Liu, Mingzhang Li, Yudong Qiu, Buqiang Wu, Jinfang Zheng, Xiaoliang Chen, Haihong Zhu, Kejun Hua, Maolin Yan, Peng Wang, Hong Zang, Xiaoming Ma, Jian Hong, Yingbin Liu

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.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Workflow of data collection and quality control in CRGGC. CRGGC, Chinese Research Group of Gallbladder Cancer; GBC, gallbladder cancer.

References

    1. Hundal R, Shaffer EA. Gallbladder cancer: epidemiology and outcome. Clin Epidemiol 2014;6:99–109. 10.2147/CLEP.S37357
    1. Misra S, Chaturvedi A, Misra NC, et al. . Carcinoma of the gallbladder. Lancet Oncol 2003;4:167–76. 10.1016/S1470-2045(03)01021-0
    1. Li M, Zhang Z, Li X, et al. . Whole-Exome and targeted gene sequencing of gallbladder carcinoma identifies recurrent mutations in the ErbB pathway. Nat Genet 2014;46:872–6. 10.1038/ng.3030
    1. Lindnér P, Holmberg E, Hafström L. Gallbladder cancer - no improvement in survival over time in a Swedish population. Acta Oncol 2018;57:1482–9. 10.1080/0284186X.2018.1478124
    1. Surveillance, epidemiology, and end results (SEER) program () research data (1973-2016), National cancer Institute, DCCPS, surveillance research program, released April 2019, based on the may 2019 submission.
    1. Creasy JM, Goldman DA, Gonen M, et al. . Evolution of surgical management of gallbladder carcinoma and impact on outcome: results from two decades at a single-institution. HPB 2019;21:1541–51. 10.1016/j.hpb.2019.03.370
    1. NCCN clinical practice guidelines in oncology: hepatobiliary cancers, version 4. 2019: national comprehensive cancer network, 2019. Available: [Accessed 2020-02-13].
    1. American Joint Committee on Cancer Ajcc cancer staging manual. 8th Edition, 2017.
    1. Shindoh J, de Aretxabala X, Aloia TA, et al. . Tumor location is a strong predictor of tumor progression and survival in T2 gallbladder cancer: an international multicenter study. Ann Surg 2015;261:733–9. 10.1097/SLA.0000000000000728
    1. Amini N, Kim Y, Wilson A, et al. . Prognostic implications of lymph node status for patients with gallbladder cancer: a multi-institutional study. Ann Surg Oncol 2016;23:3016–23. 10.1245/s10434-016-5243-y
    1. Ito H, Ito K, D'Angelica M, et al. . Accurate staging for gallbladder cancer: implications for surgical therapy and pathological assessment. Ann Surg 2011;254:320–5. 10.1097/SLA.0b013e31822238d8
    1. Tuo J, Zhang M, Zheng R. [Report of incidence and mortality of gallbladder cancer in China, 2014]. Chin J Oncol 2018;40:894–9.
    1. Bray F, Ferlay J, Soerjomataram I, et al. . Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68:394–424. 10.3322/caac.21492
    1. Vo E, Curley SA, Chai CY, et al. . National failure of surgical staging for T1b gallbladder cancer. Ann Surg Oncol 2019;26:604–10. 10.1245/s10434-018-7064-7
    1. American College of Surgeons Facility oncology registry data system. 3rd ed Chicago, IL, 2002.
    1. Collaborative Stage Work Group of the American Joint Committee on Cancer Collaborative stage data collection system user documentation and coding instructions. version 02.04. Chicago, IL: American Joint Committee on Cancer, 2012.
    1. Zou S, Zhang L. [Clinical epidemiologic characteristics of carcinoma of gallbladder in China]. Chinese Journal of Practical Surgery 2000;20:43–6.
    1. Shen H, Song H, Wang L. [Clinical feature of gallbladder cancer in Northwestern China: a report of 2379 cases from 17 institutions]. Chinese Journal of Surgery 2015;53:747–51.
    1. Hsing AW, Gao YT, Devesa SS, et al. . Rising incidence of biliary tract cancers in Shanghai, China. Int J Cancer 1998;75:368–70. 10.1002/(SICI)1097-0215(19980130)75:3<368::AID-IJC7>;2-0
    1. Bao P-P, Zheng Y, Wu C-X, et al. . Cancer incidence in urban Shanghai, 1973-2010: an updated trend and age-period-cohort effects. BMC Cancer 2016;16:284. 10.1186/s12885-016-2313-2
    1. Brierley JD, Gospodarowicz MK, Wittekind C. Tnm classification of malignant tumours. 8th ed Wiley, 2018.
    1. Kishi Y, Shimada K, Hata S, et al. . Definition of T3/4 and regional lymph nodes in gallbladder cancer: which is more valid, the UICC or the Japanese staging system? Ann Surg Oncol 2012;19:3567–73. 10.1245/s10434-012-2599-5
    1. World Health Organization International classification of diseases for oncology (ICD-O) – 3rd edition, 1st revision. 3rd ed. ed. Geneva, 2013.
    1. Hata T, Motoi F, Ishida M, et al. . Effect of hospital volume on surgical outcomes after pancreaticoduodenectomy: a systematic review and meta-analysis. Ann Surg 2016;263:664–72. 10.1097/SLA.0000000000001437
    1. Chinese Society of Biliary Surgery. [Guidelines for the diagnosis and treatment of gallbladder carcinoma (2015 edition)]. Chin J Dig Surg 2015;14:881–90.
    1. Bergquist JR, Shah HN, Habermann EB, et al. . Adjuvant systemic therapy after resection of node positive gallbladder cancer: time for a well-designed trial? (results of a US-national retrospective cohort study). Int J Surg 2018;52:171–9. 10.1016/j.ijsu.2018.02.052

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