Clinical trial NCT03499782: Precise Treatment System of Biliary Malignancies Based on Special Disease Database
Official title: A Multi-center Study：Surgical Optimization and Prognosis Auxiliary System of Biliary Malignancies Based on Special Disease Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholangiocarcinoma
Gall Bladder Carcinoma
Biliary System Disorder
Keywords: Prognosis
Surgery options
Bayesian networks
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital Xi'an Jiaotong University
name: The First Affiliated Hospital of Zhengzhou University
name: The First Affiliated Hospital of Dalian Medical University
name: Shanghai Zhongshan Hospital
name: Southwest Hospital, China
name: Tianjin Medical University Cancer Institute and Hospital
name: Sun Yat-sen University
name: Afﬁliated Hospital of North Sichuan Medical College
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Eastern Hepatobiliary Surgery Hospital
First posted: 2018-04-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Diagnosed with Gallbladder carcinoma or cholangiocarcinoma

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Death from biliary tract carcinoma
timeFrame: Every three months, up to five years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhaohui Tang
state: Shanghai
Study officials:
affiliation: the first affiliated hospital of xi'an Jiaotong univerisity
name: Zhimin Geng, MD,PhD
role: STUDY_DIRECTOR
affiliation: the first affiliated hospital of Dalian medical univerisity
name: Peng Gong, MD,PhD
role: STUDY_DIRECTOR
affiliation: Southwest Hospital, China
name: Yu He, MD,PhD
role: STUDY_DIRECTOR
affiliation: Cancer Institute and Hospital Affiliated to Sun Yat-sen University
name: Shengping Li, MD,PhD
role: STUDY_DIRECTOR
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Yinghe Qiu, MD,PhD
role: STUDY_DIRECTOR
affiliation: Shanghai Zhongshan Hospital
name: Zhi Dai, MD,PhD
role: STUDY_DIRECTOR
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Tianqiang Song, MD,PhD
role: STUDY_DIRECTOR
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Yudong Qiu, MD,PhD
role: STUDY_DIRECTOR
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jianying Lou, MD,PhD
role: STUDY_DIRECTOR
affiliation: Affliated Hospital of North Sichuan Medical College
name: Jingdong Li, MD,PdD
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Wenlong Zhai, MD,PhD
role: STUDY_DIRECTOR
References: