ClinicalTrials.gg
Status unknownNCT03499782Updated Apr 17, 2018

Precise Treatment System of Biliary Malignancies Based on Special Disease Database

An observational study in Cholangiocarcinoma, Gall Bladder Carcinoma and Biliary System Disorder, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-17.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cholangiocarcinoma
  • Gall Bladder Carcinoma
  • Biliary System Disorder

Keywords

  • Prognosis
  • Surgery options
  • Bayesian networks
03

In context

Cholangiocarcinoma

824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 196 across 161 observational studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients Diagnosed with Gallbladder carcinoma or cholangiocarcinoma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of biliary 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

Exclusion Criteria:

  • Non-primary gallbladder or cholangiocarcinoma
  • With distant (M1 phase)
  • Incomplete follow-up data
  • Died within 30 days after surgery.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Death from biliary tract carcinoma

    Death from cholangiocarcinoma or gallbladder carcinoma

    Time frame: Every three months, up to five years

07

Study locations

1 of 1 sites recruiting
  • Zhaohui Tang
    Shanghai, Shanghai 200092, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2018; primary completion for Aug 2021, 39 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 8, 2018
First posted
Apr 17, 2018
StartEst.
May 25, 2018
Primary completionEst.
Aug 31, 2021
CompletionEst.
Dec 31, 2021
Last update
Apr 17, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03499782
Responsible party
Zhaohui Tang (Professor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Apr 17, 2018
Start date
May 25, 2018 (estimated)
Primary completion
Aug 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Apr 17, 2018

Study contacts

Zhaohui Tang, MD,PhD
Contact
tangzhaohui@yahoo.com
+86 13601789458
Miaoyan Wei, MD,PhD
Contact
doctor_vmy@163.com
+86 18516574578
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, School of Medicine, Zhejiang University
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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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