Precise Treatment System of Biliary Malignancies Based on Special Disease Database

NCT03499782 — Unknown, 10000 participants, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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A Multi-center Study：Surgical Optimization and Prognosis Auxiliary System of Biliary Malignancies Based on Special Disease Database

Registry	NCT03499782
Status	Unknown
Study type	Observational
Enrollment	10000 (Estimated)
Sponsor	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other); collaborators: First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Dalian Medical University, Shanghai Zhongshan Hospital, Southwest Hospital, China, Tianjin Medical University Cancer Institute and Hospital, Sun Yat-sen University, Afﬁliated Hospital of North Sichuan Medical College, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Second Affiliated Hospital, Zhejiang University, School of Medicine, Eastern Hepatobiliary Surgery Hospital
Conditions	Cholangiocarcinoma, Gall Bladder Carcinoma, Biliary System Disorder
Dates	start 2018-05-25 (estimated), primary completion 2021-08-31 (estimated), completion 2021-12-31 (estimated), first posted 2018-04-17, last updated 2018-04-17
Locations	1 site in China

-Summary

Malignant tumors of biliary system lack standard treatment and precise prognosis assessment methods. This study including 12 hospitals, collecting clinical and follow-up data of patients with biliary malignant tumors including cholangiocarcinoma and gallbladder carcinoma in recent 10 years, aim to build a special disease database, then use Bayesian networks and importance theory to establish a mathematical model to assess treatment strategies and prognosis accurately. At the same time, data on biliary malignant tumors newly treated by multicenters from 2018 to 2020 will be included to validate, adjust and refine the models to guide clinical individualized precise treatment.

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+Outcome measures

Primary outcomes

Death from biliary tract carcinoma [Every three months, up to five years]: Death from cholangiocarcinoma or gallbladder carcinoma

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria：

* Clinical diagnosis of biliary malignancy including gallbladder carcinoma or cholangiocarcinoma verified by pathological results
* Must be able to undergo surgery
* Undergoing radical surgery for biliary malignancy (R0 or R1 resection)
* Not complicated with other malignancy
* No other treatments before and during surgery, such as radiotherapy and chemotherapy.

Exclusion Criteria:

* Non-primary gallbladder or cholangiocarcinoma
* With distant metastasis (M1 phase)
* Incomplete follow-up data
* Died within 30 days after surgery.

+Locations (1)

Facility	City	Country	Status
Zhaohui Tang	Shanghai, Shanghai Municipality	China	Recruiting

+Investigators

Zhimin Geng, MD,PhD, Study director, the first affiliated hospital of xi'an Jiaotong univerisity
Peng Gong, MD,PhD, Study director, the first affiliated hospital of Dalian medical univerisity
Yu He, MD,PhD, Study director, Southwest Hospital, China
Shengping Li, MD,PhD, Study director, Cancer Institute and Hospital Affiliated to Sun Yat-sen University
Yinghe Qiu, MD,PhD, Study director, Eastern Hepatobiliary Surgery Hospital
Zhi Dai, MD,PhD, Study director, Shanghai Zhongshan Hospital
Tianqiang Song, MD,PhD, Study director, Tianjin Medical University Cancer Institute and Hospital
Yudong Qiu, MD,PhD, Study director, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Jianying Lou, MD,PhD, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
Jingdong Li, MD,PdD, Study director, Affliated Hospital of North Sichuan Medical College
Wenlong Zhai, MD,PhD, Study director, The First Affiliated Hospital of Zhengzhou University