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Recruiting NCT07096895

EUS-directed Transenteric ERCP (EDEE) in Patients With Benign and Malignant Underlying Conditions and Inaccessible Papilla/Biliodigestive Anastomosis (BDA)

No phase Interventional Biliary Intervention Altered Anatomy Malignant Gastric Outlet Obstruction EUS Guided Enteroenteric Anastomosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EDEE (EUS-directed transenteric ERCP).
Who it may be relevant to
Registry conditions: Biliary Intervention, Altered Anatomy, Malignant Gastric Outlet Obstruction, EUS Guided Enteroenteric Anastomosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Procedure EDEE (EUS-directed transenteric ERCP)
    Technical aspects of EUS-guided anastomosis and ERCP via LAMS (Lumen apposing metal stent)

Primary outcome measures

  • Technical success rate [Time frame: during the procedure]
  • Safety of EDEE [Time frame: during the procedure]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • signed consent form
  • Indication for an EDEE
  • Age >18 years

Exclusion criteria

  • Age < 18 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Evangelisches Krankenhaus Düsseldorf — Düsseldorf

Identifiers

NCT: NCT07096895 · EDEE EVK Duesseldorf

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗