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)

Study Overview

• Status: Recruiting
• Conditions: Malignant Gastric Outlet Obstruction; Altered Anatomy; Biliary Intervention; EUS Guided Enteroenteric Anastomosis; EDEE
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carina Friesl; Phone Number: +49 211 919 2171; Email: carina.friesl@evk-duesseldorf.de
• Study Contact Backup: Name: Leonie Dr. med. Grossmann; Phone Number: +49 211 919 1605; Email: Leonie.Grossmann@evk-duesseldorf.de

Study Locations

• Germany
  • Düsseldorf, Germany, 40217
    • Recruiting
    • Evangelisches Krankenhaus Düsseldorf
    • Contact: Carina Friesl; Phone Number: 02119192171; Email: carina.friesl@evk-duesseldorf.de
    • Sub-Investigator: Leonie Dr. med. Grossmann
    • Sub-Investigator: Thomas Dr. med. Veiser

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Age < 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EDEE	Procedure: EDEE (EUS-directed transenteric ERCP); Technical aspects of EUS-guided anastomosis and ERCP via LAMS (Lumen apposing metal stent)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	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	during the procedure
Safety of EDEE	number and rate of patients, in whom a procedure related complication occured	during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success rate	absence of need for alternative drainage	at the day of last procedure
Technical aspects of gastro-enterostomy	Evaluation of devices and potential pitfalls creating a gastroenterostomy	during the procedure
Techinical aspect of ERCP via LAMS	Evaluation of devices and potential pitfalls performing ERCP via LAMS	during procedure
Requirement for reinterventions		during the procedure

Collaborators and Investigators

• Sponsor: Evangelisches Krankenhaus Düsseldorf
• Investigators: Principal Investigator: Torsten PD Dr. med Beyna, Evangelisches Krankenhaus Düsseldorf

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 24, 2025
• First Submitted That Met QC Criteria: July 24, 2025
• First Posted (Actual): July 31, 2025

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: ERCP; EUS; anastomosis; altered anatomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastric Outlet Obstruction; Pyloric Stenosis
• Other Study ID Numbers: EDEE EVK Duesseldorf

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No