Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217, Germany
Location status: Recruiting
Location contact
Carina Friesl
CONTACT
Leonie Dr. med. Grossmann
SUB_INVESTIGATOR
Thomas Dr. med. Veiser
SUB_INVESTIGATOR
NCT Number: NCT07096895
Safety and efficacy of EDEE (EUS-directed transenteric ERCP)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Düsseldorf, 40217, Germany
Location status: Recruiting
Carina Friesl
CONTACT
Leonie Dr. med. Grossmann
SUB_INVESTIGATOR
Thomas Dr. med. Veiser
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Technical aspects of EUS-guided anastomosis and ERCP via LAMS (Lumen apposing metal stent)
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
Time frame: during the procedure
number and rate of patients, in whom a procedure related complication occured
Time frame: at the day of last procedure
absence of need for alternative drainage
Time frame: during the procedure
Evaluation of devices and potential pitfalls creating a gastroenterostomy
Time frame: during procedure
Evaluation of devices and potential pitfalls performing ERCP via LAMS
Time frame: during the procedure
Contact information is provided by the study sponsor or research team.
Carina Friesl
CONTACT
Leonie Dr. med. Grossmann
CONTACT
Evangelisches Krankenhaus Düsseldorf
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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