NCT07096895

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2020Jan 2027

Study Start

First participant enrolled

February 1, 2020

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

6.9 years

First QC Date

July 24, 2025

Last Update Submit

July 24, 2025

Conditions

Biliary InterventionAltered AnatomyMalignant Gastric Outlet ObstructionEUS Guided Enteroenteric AnastomosisEDEE

Keywords

ERCPaltered anatomyEUSanastomosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Clinical success rate

    at the day of last procedure

  • Technical aspects of gastro-enterostomy

    during the procedure

  • Techinical aspect of ERCP via LAMS

    during procedure

  • Requirement for reinterventions

    during the procedure

Study Arms (1)

EDEE

EXPERIMENTAL
Procedure: EDEE (EUS-directed transenteric ERCP)

Interventions

EDEE (EUS-directed transenteric ERCP)PROCEDURE

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

EDEE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, 40217, Germany

RECRUITING

Study Officials

  • Torsten PD Dr. med Beyna

    Evangelisches Krankenhaus Düsseldorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina Friesl

CONTACT

+49 211 919 2171carina.friesl@evk-duesseldorf.de

Leonie Dr. med. Grossmann

CONTACT

+49 211 919 1605Leonie.Grossmann@evk-duesseldorf.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med

Study Record Dates

First Submitted

July 24, 2025

First Posted

July 31, 2025

Study Start

February 1, 2020

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)