Cholangiopancreatography, Endoscopic RetrogradeNCT06310460
Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation
An observational study of Cholangiopancreatography, Endoscopic Retrograde, run by Kliniken Ludwigsburg-Bietigheim gGmbH.
Trial summary
To evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiopancreatography, Endoscopic Retrograde
- What is being tested?
- Papillectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 28 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing ERCP with intented bile duct cannulation
Who may be able to join
- Difficult cannulation of bile duct
Who cannot join
- post-surgical upper GI anatomy
- previous endoscopic retrograde cholangiopancreaticography or percutaneous transhepatic cholangiography
- papilla within a diverticulum
- coagulation disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Monocentric Cohort Study to Evluate Pre-cut Papillectomy in Patients With Difficult Biliary Cannulation During Endoscopic Retrograde Cholangiopancreaticography
To evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation.
- Being tested
- Papillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PapillectomyProcedure or surgery
Papillectomy prior to bile duct cannulation during ERCP
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of treatment success
Rate of successful cannulation of the bile duct after PreCut-papillectomy
Measured: During endoscopy
Adverse event rate
Rate of adverse events, as classifed by ASGE classification
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiopancreatography, Endoscopic RetrogradeStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310460
- Sponsor's protocol ID
- PCP
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monocentric Cohort Study to Evluate Pre-cut Papillectomy in Patients With Difficult Biliary Cannulation During Endoscopic Retrograde Cholangiopancreaticography
- ClinicalTrials.gov ID
- NCT06310460
- Acronym / sponsor ID
- PCP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbHUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- 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 evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing ERCP with intented bile duct cannulation
Key inclusion criteria (1 listed)
- Difficult cannulation of bile duct
Key exclusion criteria (4 listed)
- post-surgical upper GI anatomy
- previous endoscopic retrograde cholangiopancreaticography or percutaneous transhepatic cholangiography
- papilla within a diverticulum
- coagulation disorder
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 |
|---|---|---|
| PapillectomyPapillectomy prior to bile duct cannulation during ERCP | Procedure or surgery | – |
Primary outcome
Rate of treatment success
Time frame: During endoscopy
Rate of successful cannulation of the bile duct after PreCut-papillectomy
Adverse event rate
Time frame: Up to 30 days
Rate of adverse events, as classifed by ASGE classification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiopancreatography, Endoscopic Retrograde, run by Kliniken Ludwigsburg-Bietigheim gGmbH.
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 4 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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Andreas Wannhoff, Dr. (+49-7141-67204, Andreas.Wannhoff@rkh-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of treatment success (time frame: During endoscopy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 15 Mar 2024.