Bile Duct Stricture Not Treatable by ERCNCT00942630
Value of Percutaneous Cholangioscopy After Placement of a Percutaneous Transhepatic Biliary Drainage
An observational study of Bile Duct Stricture Not Treatable by ERC, run by Hannover Medical School at 1 site in Germany.
Trial summary
In a prospective study the investigators perform repeated cholangioscopies in all patients that received percutaneous transhepatic biliary drainage (PTBD) for a variety of malignant and benign diseases. Endoscopic findings and their correlation with clinical features will be recorded prospectively. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Bile Duct Stricture Not Treatable by ERC
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Apr 2011
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients receiving a PTBD
Who may be able to join
- PTBD with at least 14 French in diameter
Who cannot join
- missing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Cholangioscopy After Placement of a Percutaneous Transhepatic Biliary Drainage (PTBD) - a Prospective Study on Endoscopic Findings and Clinical Impact
In a prospective study the investigators perform repeated cholangioscopies in all patients that received percutaneous transhepatic biliary drainage (PTBD) for a variety of malignant and benign diseases. Endoscopic findings and their correlation with clinical features will be recorded prospectively. The impact on clinical decision will be evaluated.
- Conditions
- Bile Duct Stricture Not Treatable by ERC
- Keywords
- percutaneous, transhepatic, biliary, drainage, cholangioscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct Stricture Not Treatable by ERCStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias J. Weismueller, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942630
- Sponsor's protocol ID
- MHH-ENDO-0709
- Status last verified
- Oct 2011
- First submitted
- 20 Jul 2009
- Last updated
- 10 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Cholangioscopy After Placement of a Percutaneous Transhepatic Biliary Drainage (PTBD) - a Prospective Study on Endoscopic Findings and Clinical Impact
- ClinicalTrials.gov ID
- NCT00942630
- Acronym / sponsor ID
- MHH-ENDO-0709
- Conditions
- Bile Duct Stricture Not Treatable by ERC
- Keywords
- percutaneous, transhepatic, biliary, drainage, cholangioscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 21 Jul 2009 (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.
In a prospective study the investigators perform repeated cholangioscopies in all patients that received percutaneous transhepatic biliary drainage (PTBD) for a variety of malignant and benign diseases. Endoscopic findings and their correlation with clinical features will be recorded prospectively. The impact on clinical decision will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receiving a PTBD
Key inclusion criteria (1 listed)
- PTBD with at least 14 French in diameter
Key exclusion criteria (1 listed)
- missing informed consent
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2011.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bile Duct Stricture Not Treatable by ERC, run by Hannover Medical School at 1 site in Germany.
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: finished, as of the sponsor's last update on 10 Oct 2011. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 10 Oct 2011.