Malignant Biliary ObstructionMBO-IRNCT01073514
Clinical Trial of Bile Etiology ,Proteomics and Metabonomics of Malignant Biliary Obstruction
An observational study of Malignant Biliary Obstruction, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Biliary Obstruction
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Malignant obstructive jaundice (MBO)
Who may be able to join
- Those with MBO who can receive Percutaneous Transhepatic Biliary Drainage(PTBD)
Who cannot join
- Those with MBO who cannot receive Percutaneous Transhepatic Biliary Drainage(PTBD)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institude and Hospital
Tianjin, Tianjin Municipality, 300060
YU HAIPENG, MD, 13352070835, JIERUKE@YAHOO.COM.CN
GUO ZHI, professor
About this study
Official title: Clinical Trial of Bile Etiology,Proteomics and Metabonomics of Malignant Biliary Obstruction
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.
Read the detailed description
We will obtain bile sample for culture and susceptibility ,proteomics metabonomics test after PTBD. Also get the blood and urine samples.
- Conditions
- Malignant Biliary Obstruction
- Keywords
- Malignant biliary obstruction (MBO)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YU HAI PENG, MD, Principal investigator, Tianjin Medical University Cancer Institute and HospitalGUO ZHI, Professor, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073514
- Sponsor's protocol ID
- TMU-CIH-IR-001
- Other IDs
- ChiCTR-ONC-00000752
- Acronym
- MBO-IR
- Status last verified
- Feb 2010
- First submitted
- 21 Feb 2010
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Bile Etiology,Proteomics and Metabonomics of Malignant Biliary Obstruction
- ClinicalTrials.gov ID
- NCT01073514
- Acronym / sponsor ID
- MBO-IR / TMU-CIH-IR-001
- Conditions
- Malignant Biliary Obstruction
- Keywords
- Malignant biliary obstruction (MBO)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will obtain bile sample for culture and susceptibility ,proteomics metabonomics test after PTBD. Also get the blood and urine samples.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Malignant obstructive jaundice (MBO)
Key inclusion criteria (1 listed)
- Those with MBO who can receive Percutaneous Transhepatic Biliary Drainage(PTBD)
Key exclusion criteria (1 listed)
- Those with MBO who cannot receive Percutaneous Transhepatic Biliary Drainage(PTBD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YU HAI PENG, MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
GUO ZHI, Professor study chair
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Biliary Obstruction, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YU HAI PENG, MD (13352070835, JIERUKE@YAHOO.COM.CN), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015.