Altered Anatomy, Biliary Intervention, EDEE, EUS Guided Enteroenteric Anastomosis, Malignant Gastric Outlet Obstruction
Conditions
Keywords
ERCP, altered anatomy, EUS, anastomosis
Brief summary
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.
Interventions
PROCEDUREEDEE (EUS-directed transenteric ERCP)
Technical aspects of EUS-guided anastomosis and ERCP via LAMS (Lumen apposing metal stent)
Sponsors
Evangelisches Krankenhaus Düsseldorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* signed consent form * Indication for an EDEE * Age \>18 years
Exclusion criteria
* Age \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | 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 | during the procedure | number and rate of patients, in whom a procedure related complication occured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success rate | at the day of last procedure | absence of need for alternative drainage |
| Technical aspects of gastro-enterostomy | during the procedure | Evaluation of devices and potential pitfalls creating a gastroenterostomy |
| Techinical aspect of ERCP via LAMS | during procedure | Evaluation of devices and potential pitfalls performing ERCP via LAMS |
| Requirement for reinterventions | during the procedure | — |
Countries
Germany
Contacts
Primary ContactCarina Friesl
Backup ContactLeonie Dr. med. Grossmann
Outcome results
None listed