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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2010 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01073514
First received: February 21, 2010
Last updated: July 31, 2014
Last verified: February 2010
  Purpose

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
Malignant Biliary Obstruction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Trial of Bile Etiology,Proteomics and Metabonomics of Malignant Biliary Obstruction

Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Biospecimen Retention:   Samples With DNA

bile,blood and urine specimen


Estimated Enrollment: 300
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 21, 2010
Last Updated: July 31, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014