Precise Treatment System of Biliary Malignancies Based on Special Disease Database

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03499782
• Other study ID #: XHEC-JDYXY-2018-002
• Status: Recruiting
• First received: April 8, 2018
• Last updated: April 13, 2018
• Start date: May 25, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Zhaohui Tang, MD,PhD
• Phone: +86 13601789458
• Email: tangzhaohui[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary System Disorder
• Cholangiocarcinoma
• Gall Bladder Carcinoma
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
China	Zhaohui Tang	Shanghai	Shanghai

Sponsors (12)

Lead Sponsor

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Af?liated Hospital of North Sichuan Medical College, Eastern Hepatobiliary Surgery Hospital, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Zhongshan Hospital, Southwest Hospital, China, Sun Yat-sen University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Zhengzhou University, Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from biliary tract carcinoma	Death from cholangiocarcinoma or gallbladder carcinoma	Every three months, up to five years