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

Not Applicable

Recruiting

• Conditions: Biliary Intervention; Altered Anatomy; Malignant Gastric Outlet Obstruction; EUS Guided Enteroenteric Anastomosis; EDEE

• Registration Number: NCT07096895
• Lead Sponsor: Evangelisches Krankenhaus Düsseldorf

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.

Study Timeline

• Study Start: 2020-02-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• Age < 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical success rate	at the day of last procedure	absence of need for alternative drainage
Requirement for reinterventions	during the procedure
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

Trial Locations

Locations (1)

Evangelisches Krankenhaus Düsseldorf; 🇩🇪 Düsseldorf, Germany