Prospective Registry Of Therapeutic EndoscopiC ulTrasound (PROTECT)

Paolo Giorgio Arcidiacono, MD

Status: Enrolling

Conditions: Chronic Pancreatitis; Gastric Outlet Obstruction; Biliary Obstruction; Acute Pancreatic Fluid Collection; Acute Cholecystitis; Acute Pancreatitis With Infected Necrosis

Treatments: Procedure: non-EUS-based endoscopic procedures; Procedure: Therapeutic EUS; Procedure: Percutaneous Procedures; Procedure: Surgical Interventions

Study type: Observational

Funder types: Other

Identifiers

NCT04813055

178/INT/2020

Details and patient eligibility

About

This registry aims to analyze long-term outcomes of therapeutic EUS (T-EUS) procedures, as well as to describe clinical and technical variables potentially predicting clinical success or adverse events, for a better selection of ideal candidates.

Full description

This is an observational, prospective, single centre study. This registry aims to evaluate long-term clinical success of EUS-guided therapeutic interventions (T-EUS), as well as adverse events, and clinical and technical variables asociated with clinical success and adverse events.

For the purpose of this registry, the following procedures will be considered to be T-EUS procedures:

• EUS-guided collection drainage
• EUS-guided biliary drainage
• EUS-guided gallbladder drainage
• EUS-guided gastro-enterostomy
• EUS-directed ERCP
• EUS-guided pancreatic duct drainage

Each patient will be assigned to a procedure following standard clinical practice, in most instances following a routinely multidisciplinary discussion.

All patients eligible for the abovementioned clinical indications, but finally undergoing alternative procedures (e.g. surgical interventions, percutaneous interventions or other endoscopic procedures) will be proposed to be enrolled in the registry as "controls". The same variables will be collected, with the exception of technical variables related to the EUS-guided intervention.

Enrollment: 510 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease
• 18 years old or older
• able to provide an informed consent to inclusion.

Exclusion criteria

• age < 18 years
• inability or unwillingness to sign the informed consent form (ICF)
• contra-indication for endoscopy or use of fluoroscopy

Trial design

510 participants in 2 patient groups

Therapeutic EUS

Description:

Procedures involving Linear Echoendoscopes to create a communication between the gastrointestinal tract and a target organ (biliary tree, pancreatic duct, fluid collection, gallbladder, downstream gastrointestinal tract) through plastic or metal stents.

Treatment:

Procedure: Therapeutic EUS

Controls

Description:

Patients eligible for T-EUS procedures, but undergoing alternative surgical interventions, percutaneous interventions (e.g. Percutaneous Biliary Drainage) or non-EUS based endoscopic procedures (e.g. enteral stenting)

Treatment:

Procedure: Surgical Interventions

Procedure: Percutaneous Procedures

Procedure: non-EUS-based endoscopic procedures