Biliary InterventionNCT07096895
EUS-directed Transenteric ERCP (EDEE) in Patients With Benign and Malignant Underlying Conditions and Inaccessible Papilla/Biliodigestive Anastomosis (BDA)
A study testing EDEE (EUS-directed transenteric ERCP) in people with Biliary Intervention and Altered Anatomy, run by Evangelisches Krankenhaus Düsseldorf at 1 site in Germany.
Trial summary
Safety and efficacy of EDEE (EUS-directed transenteric ERCP) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Intervention, Altered Anatomy, Malignant Gastric Outlet Obstruction
- What is being tested?
- EDEE (EUS-directed transenteric ERCP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2020to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- signed consent form
- Indication for an EDEE
- Age >18 years
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217
Carina Friesl, 02119192171, carina.friesl@evk-duesseldorf.de
Leonie Dr. med. Grossmann
About this study
Safety and efficacy of EDEE (EUS-directed transenteric ERCP)
Read the detailed description
Background and Study Objective Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard when biliary intervention is indicated. However, there are situations where conventional ERCP is no longer feasible - for example, in the presence of malignant gastric outlet obstruction.
Additionally, the number of patients with surgically altered anatomy due to benign or malignant underlying diseases is increasing. For this group of patients, enteroscopy-assisted ERCP can generally be considered. However, the success rate of this procedure varies depending on the anatomical situation and is only around 61.7%. Therefore, patients in whom the papilla or the biliodigestive anastomosis (BDA) cannot be reached either via conventional endoscopy or enteroscopy-assisted ERCP - yet require biliary intervention - present a particular clinical challenge.
Traditionally, the only option in such cases has often been percutaneous transhepatic drainage (PTBD). This approach frequently requires repeated procedures over several months and, in some cases, results in a permanent external drainage. In recent years, endoscopic ultrasound (EUS)-guided techniques have emerged as a promising treatment option for this patient population. These methods show a high technical success rate of approximately 90%, but are not suitable in cases requiring complex interventions (e.g., multiple strictures of the BDA) or when targeting the right biliary system.
An alternative approach involves a two-step procedure: first, an EUS-guided entero-enteric anastomosis is created using a lumen-apposing metal stent (LAMS); in a second step, ERCP is performed via the LAMS. This procedure is referred to in the literature as Endoscopic Ultrasound-Directed Transenteric ERCP (EDEE).
Since only a few systematic studies on this alternative procedure have been published so far, the objective of this retrospective study is to assess the technical and clinical success rates and evaluate the safety of EDEE.
- Conditions
- Biliary Intervention, Altered Anatomy, Malignant Gastric Outlet Obstruction, EUS Guided Enteroenteric Anastomosis, EDEE
- Being tested
- EDEE (EUS-directed transenteric ERCP)
- Keywords
- ERCP, altered anatomy, EUS, anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDEE (EUS-directed transenteric ERCP)Procedure or surgery
Technical aspects of EUS-guided anastomosis and ERCP via LAMS (Lumen apposing metal stent)
| Study group | Role | What they receive |
|---|---|---|
| EDEE | Experimental | Not described Receives: Procedure: EDEE (EUS-directed transenteric ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
number an rate of patients with successful creation of gastro-enterostomy followed by successfull ERCP via LAMS (lumen apposing metal stent) including all planned interventions
Measured: during the procedure
Safety of EDEE
number and rate of patients, in whom a procedure related complication occured
Measured: during the procedure
Secondary outcomes (4)
Clinical success rate
absence of need for alternative drainage
Measured: at the day of last procedure
Technical aspects of gastro-enterostomy
Evaluation of devices and potential pitfalls creating a gastroenterostomy
Measured: during the procedure
Techinical aspect of ERCP via LAMS
Evaluation of devices and potential pitfalls performing ERCP via LAMS
Measured: during procedure
Requirement for reinterventions
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Feb 2020
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary InterventionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangelisches Krankenhaus Düsseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torsten Beyna, Evangelisches Krankenhaus Düsseldorf
- Investigators
- Torsten PD Dr. med Beyna, Principal investigator, Evangelisches Krankenhaus Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096895
- Sponsor's protocol ID
- EDEE EVK Duesseldorf
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-directed Transenteric ERCP (EDEE) in Patients With Benign and Malignant Underlying Conditions and Inaccessible Papilla/Biliodigestive Anastomosis (BDA)
- ClinicalTrials.gov ID
- NCT07096895
- Acronym / sponsor ID
- EDEE EVK Duesseldorf
- Conditions
- Biliary Intervention, Altered Anatomy, Malignant Gastric Outlet Obstruction, EUS Guided Enteroenteric Anastomosis, EDEE
- Keywords
- ERCP, altered anatomy, EUS, anastomosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Evangelisches Krankenhaus DüsseldorfUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 31 Jul 2025 (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.
Safety and efficacy of EDEE (EUS-directed transenteric ERCP)
Detailed description
Background and Study Objective Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard when biliary intervention is indicated. However, there are situations where conventional ERCP is no longer feasible - for example, in the presence of malignant gastric outlet obstruction.
Additionally, the number of patients with surgically altered anatomy due to benign or malignant underlying diseases is increasing. For this group of patients, enteroscopy-assisted ERCP can generally be considered. However, the success rate of this procedure varies depending on the anatomical situation and is only around 61.7%. Therefore, patients in whom the papilla or the biliodigestive anastomosis (BDA) cannot be reached either via conventional endoscopy or enteroscopy-assisted ERCP - yet require biliary intervention - present a particular clinical challenge.
Traditionally, the only option in such cases has often been percutaneous transhepatic drainage (PTBD). This approach frequently requires repeated procedures over several months and, in some cases, results in a permanent external drainage. In recent years, endoscopic ultrasound (EUS)-guided techniques have emerged as a promising treatment option for this patient population. These methods show a high technical success rate of approximately 90%, but are not suitable in cases requiring complex interventions (e.g., multiple strictures of the BDA) or when targeting the right biliary system.
An alternative approach involves a two-step procedure: first, an EUS-guided entero-enteric anastomosis is created using a lumen-apposing metal stent (LAMS); in a second step, ERCP is performed via the LAMS. This procedure is referred to in the literature as Endoscopic Ultrasound-Directed Transenteric ERCP (EDEE).
Since only a few systematic studies on this alternative procedure have been published so far, the objective of this retrospective study is to assess the technical and clinical success rates and evaluate the safety of EDEE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EDEE | Experimental | Procedure: EDEE (EUS-directed transenteric ERCP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- signed consent form
- Indication for an EDEE
- Age >18 years
Key exclusion criteria (1 listed)
- Age < 18 years
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 |
|---|---|---|
| EDEE (EUS-directed transenteric ERCP)Technical aspects of EUS-guided anastomosis and ERCP via LAMS (Lumen apposing metal stent) | Procedure or surgery | EDEE |
Primary outcome
Technical success rate
Time frame: during the procedure
number an rate of patients with successful creation of gastro-enterostomy followed by successfull ERCP via LAMS (lumen apposing metal stent) including all planned interventions
Safety of EDEE
Time frame: during the procedure
number and rate of patients, in whom a procedure related complication occured
4 secondary outcomes
Clinical success rate
Time frame: at the day of last procedure
Technical aspects of gastro-enterostomy
Time frame: during the procedure
Techinical aspect of ERCP via LAMS
Time frame: during procedure
Requirement for reinterventions
Time frame: during the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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.
Torsten PD Dr. med Beyna principal investigator
Evangelisches Krankenhaus Düsseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDEE (EUS-directed transenteric ERCP) in people with Biliary Intervention and Altered Anatomy, run by Evangelisches Krankenhaus Düsseldorf 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 3 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carina Friesl (+49 211 919 2171, carina.friesl@evk-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: during the procedure). 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 31 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.