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NCT Number: NCT07096895

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

Safety and efficacy of EDEE (EUS-directed transenteric ERCP)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, 40217, Germany

Location status: Recruiting

Location contact

Carina Friesl

CONTACT

[email protected]

02119192171

Leonie Dr. med. Grossmann

SUB_INVESTIGATOR

Thomas Dr. med. Veiser

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age < 18 years

Treatment and study plan

EDEE (EUS-directed transenteric ERCP)

Procedure

Technical aspects of EUS-guided anastomosis and ERCP via LAMS (Lumen apposing metal stent)

Primary outcomes

  1. 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

  2. Safety of EDEE

    Time frame: during the procedure

    number and rate of patients, in whom a procedure related complication occured

Secondary outcomes

  1. Clinical success rate

    Time frame: at the day of last procedure

    absence of need for alternative drainage

  2. Technical aspects of gastro-enterostomy

    Time frame: during the procedure

    Evaluation of devices and potential pitfalls creating a gastroenterostomy

  3. Techinical aspect of ERCP via LAMS

    Time frame: during procedure

    Evaluation of devices and potential pitfalls performing ERCP via LAMS

  4. Requirement for reinterventions

    Time frame: during the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Carina Friesl

CONTACT

[email protected]

+49 211 919 2171

Leonie Dr. med. Grossmann

CONTACT

[email protected]

+49 211 919 1605

Sponsors and collaborators

Lead sponsor

Evangelisches Krankenhaus Düsseldorf

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

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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