EUS-directed Transenteric ERCP (EDEE) in Patients With Benign and Malignant Underlying Conditions and Inaccessible Papilla/Biliodigestive Anastomosis (BDA)
NCT ID: NCT07096895
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2020-02-01
2027-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EDEE
EDEE (EUS-directed transenteric ERCP)
Technical aspects of EUS-guided anastomosis and ERCP via LAMS (Lumen apposing metal stent)
Interventions
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EDEE (EUS-directed transenteric ERCP)
Technical aspects of EUS-guided anastomosis and ERCP via LAMS (Lumen apposing metal stent)
Eligibility Criteria
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Inclusion Criteria
* Indication for an EDEE
* Age \>18 years
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Evangelisches Krankenhaus Düsseldorf
OTHER
Responsible Party
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Torsten Beyna
PD Dr. med
Principal Investigators
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Torsten PD Dr. med Beyna
Role: PRINCIPAL_INVESTIGATOR
Evangelisches Krankenhaus Düsseldorf
Locations
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Evangelisches Krankenhaus Düsseldorf
Düsseldorf, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EDEE EVK Duesseldorf
Identifier Type: -
Identifier Source: org_study_id
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