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Clinical Trial of Bile Etiology ,Proteomics and Metabonomics of Malignant Biliary Obstruction (MBO—IR)

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ClinicalTrials.gov Identifier: NCT01073514
Recruitment Status : Unknown
Verified February 2010 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
First Posted : February 23, 2010
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief 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.

Condition or disease
Malignant Biliary Obstruction

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

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Trial of Bile Etiology,Proteomics and Metabonomics of Malignant Biliary Obstruction
Study Start Date : December 2009
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016



Biospecimen Retention:   Samples With DNA
bile,blood and urine specimen


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Malignant obstructive jaundice (MBO)
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073514


Contacts
Contact: YU HAI PENG, MD 13352070835 JIERUKE@YAHOO.COM.CN

Locations
China, Tianjin
Tianjin Medical University Cancer Institude and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: YU HAIPENG, MD    13352070835    JIERUKE@YAHOO.COM.CN   
Principal Investigator: GUO ZHI, professor         
Sub-Investigator: YU Haipeng, MD         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Principal Investigator: YU HAI PENG, MD Tianjin Medical University Cancer Institute and Hospital
Study Chair: GUO ZHI, Professor Tianjin Medical University Cancer Institute and Hospital

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01073514     History of Changes
Other Study ID Numbers: TMU-CIH-IR-001
ChiCTR-ONC-00000752 ( Registry Identifier: Chinese Clinical Trial Register(http://www.chictr.org) )
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: February 2010

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Malignant biliary obstruction (MBO)