CholangiographyDBE ERCNCT00454129
ERC Via Double-Balloon-Enteroscopy in Patients With Biliodigestive Anastomosis
A study testing cholangiography via double-balloon enteroscopy and MR cholangiography in people with Cholangiography, run by Heidelberg University at 1 site in Germany.
Trial summary
In patients with biliodigestive anastomosis direct cholangiography (ERC) is due to changed anatomy commonly not possible. The aim of the study is to test the feasibility to perform direct cholangiography in these patients via double-balloon enteroscopy and to compare it to MR cholangiography. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholangiography
- What is being tested?
- cholangiography via double-balloon enteroscopy and MR cholangiography
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Mar 2007to not given
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biliodigestive anastomosis; and
- Suspicion of biliary disorder
Who cannot join
- Exclusion criteria of double-balloon enteroscopy and MR-cholangiography
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medical University of Heidelberg, Department of Gastroenterology
Heidelberg, 69120
Jens Encke, Prof.
About this study
In patients with biliodigestive anastomosis direct cholangiography (ERC) is due to changed anatomy commonly not possible. The aim of the study is to test the feasibility to perform direct cholangiography in these patients via double-balloon enteroscopy and to compare it to MR cholangiography.
- Conditions
- Cholangiography
- Being tested
- cholangiography via double-balloon enteroscopy, MR cholangiography
- Keywords
- Feasibilty of cholangiography via double-balloon enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholangiography via double-balloon enteroscopyProcedure or surgery
MR cholangiographyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiographyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Jens Encke, Prof., Principal investigator, Medical University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454129
- Sponsor's protocol ID
- DBE ERC
- Acronym
- DBE ERC
- Status last verified
- Mar 2007
- First submitted
- 29 Mar 2007
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERC Via Double-Balloon-Enteroscopy in Patients With Biliodigestive Anastomosis
- ClinicalTrials.gov ID
- NCT00454129
- Acronym / sponsor ID
- DBE ERC / DBE ERC
- Conditions
- Cholangiography
- Keywords
- Feasibilty of cholangiography via double-balloon enteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Mar 2007
- First posted
- 30 Mar 2007 (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 patients with biliodigestive anastomosis direct cholangiography (ERC) is due to changed anatomy commonly not possible. The aim of the study is to test the feasibility to perform direct cholangiography in these patients via double-balloon enteroscopy and to compare it to MR cholangiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Biliodigestive anastomosis; and
- Suspicion of biliary disorder
Key exclusion criteria (1 listed)
- Exclusion criteria of double-balloon enteroscopy and MR-cholangiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholangiography via double-balloon enteroscopy | Procedure or surgery | – |
| MR cholangiography | Procedure or surgery | – |
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 28 Jan 2013.
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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.
Jens Encke, Prof. principal investigator
Medical University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholangiography via double-balloon enteroscopy and MR cholangiography in people with Cholangiography, run by Heidelberg University 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 2 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 28 Jan 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Encke, Prof. (+49-6221-568611, jens_encke@med.uni-heidelberg.de), 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 28 Jan 2013.