Health TrialsbyHealthPanel

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

ConditionsBiliary InterventionAltered AnatomyMalignant Gastric Outlet ObstructionEUS Guided Enteroenteric AnastomosisEDEE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEvangelisches Krankenhaus Düsseldorf

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

signed consent form

Indication for an EDEE

Age >18 years

Disqualifiers

Age < 18 years

Trial design

Design model

Single group

Treatments tested in this trial

  • EDEE (EUS-directed transenteric ERCP)

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: EDEEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
during the procedure
2

Safety of EDEE

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

Time frame
during the procedure

Secondary outcomes

1

Clinical success rate

absence of need for alternative drainage

Time frame
at the day of last procedure
2

Technical aspects of gastro-enterostomy

Evaluation of devices and potential pitfalls creating a gastroenterostomy

Time frame
during the procedure
3

Techinical aspect of ERCP via LAMS

Evaluation of devices and potential pitfalls performing ERCP via LAMS

Time frame
during procedure
4

Requirement for reinterventions

Time frame
during the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Evangelisches Krankenhaus Düsseldorf

Lead sponsor

Source ClinicalTrials.gov
Apply now