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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01073514
Other study ID # TMU-CIH-IR-001
Secondary ID ChiCTR-ONC-00000
Status Recruiting
Phase N/A
First received February 21, 2010
Last updated December 21, 2015
Start date December 2009
Est. completion date December 2016

Study information

Verified date February 2010
Source Tianjin Medical University Cancer Institute and Hospital
Contact YU HAI PENG, MD
Phone 13352070835
Email JIERUKE@YAHOO.COM.CN
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

To investigate bile culture and susceptibility test in patients with malignant biliary obstruction (MBO) or relation between bile, portal vein or vein culture and biliary infection. Also to get the information of bile metabonomics to find potential tumor marker .Culture of the organism is recognized as the "gold standard" for diagnosis of infection. Our research may be one of the first research on culture and susceptibility test in patients with MBO. The results of the trial research will be benefit to experiential therapy of MBO with biliary infection and diagnosis of MBO.


Description:

We will obtain bile sample for culture and susceptibility ,proteomics metabonomics test after PTBD. Also get the blood and urine samples.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Those with MBO who can receive Percutaneous Transhepatic Biliary Drainage(PTBD)

Exclusion Criteria:

- Those with MBO who cannot receive Percutaneous Transhepatic Biliary Drainage(PTBD)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Tianjin Medical University Cancer Institude and Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

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