EUS-directed transenteric ERCP to reach an inaccessible papilla or biliodigestive anastomosis
EUS-directed Transenteric ERCP (EDEE) in Patients With Benign and Malignant Underlying Conditions and Inaccessible Papilla/Biliodigestive Anastomosis (BDA)
This will try EUS-directed transenteric ERCP to reach and treat blocked bile ducts in adults whose papilla or biliodigestive anastomosis cannot be reached by conventional endoscopy or enteroscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Evangelisches Krankenhaus Düsseldorf Academic / other |
| Locations | 1 site (Düsseldorf) |
| Trial ID | NCT07096895 on ClinicalTrials.gov |
What this trial studies
Patients with surgically altered anatomy or malignant gastric outlet obstruction can have an unreachable papilla or biliodigestive anastomosis, which makes conventional ERCP impossible and often leads to percutaneous drains. This interventional protocol uses endoscopic ultrasound to create a transenteric access route and then performs ERCP through that route (EDEE) as a single-session internal biliary approach. The main focus is on procedure safety and technical/clinical success in adults who consent and require biliary intervention when standard approaches fail. The study is being conducted at a single center in Düsseldorf and enrolls patients age 18 and older.
Who should consider this trial
Good fit: Adults (age >18) who need biliary intervention but whose papilla or biliodigestive anastomosis cannot be reached by conventional endoscopy or enteroscopy and who can give informed consent are ideal candidates.
Not a fit: Patients who can be treated with standard ERCP or enteroscopy-assisted ERCP, those with contraindications to EUS or endoscopy, or those requiring interventions not suitable via a transenteric route (for example certain right-sided biliary anatomies) may not benefit.
Why it matters
Potential benefit: If successful, EDEE could provide internal biliary drainage and treatments that avoid external drains and repeated percutaneous procedures, improving comfort and quality of life.
How similar studies have performed: Other EUS-guided biliary access techniques have reported high technical success rates (around 90%) but EDEE as a directed transenteric ERCP approach is less widely studied and remains somewhat novel for complex interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * signed consent form * Indication for an EDEE * Age \>18 years Exclusion Criteria: * Age \< 18 years
Where this trial is running
Düsseldorf
- Evangelisches Krankenhaus Düsseldorf — Düsseldorf, Germany (Recruiting)
Study contacts
- Principal investigator: Torsten PD Dr. med Beyna — Evangelisches Krankenhaus Düsseldorf
- Study coordinator: Carina Friesl
- Email: carina.friesl@evk-duesseldorf.de
- Phone: +49 211 919 2171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.