Prospective Registry Of Therapeutic EndoscopiC ulTrasound — PROTECT  

Chronic Pancreatitis Clinical Trial

Official title: Prospective Registry Of Therapeutic EndoscopiC ulTrasound

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Cholecystitis
• Acute Pancreatic Fluid Collection
• Acute Pancreatitis With Infected Necrosis
• Biliary Obstruction
• Cholecystitis
• Cholecystitis, Acute
• Chronic Pancreatitis
• Gastric Outlet Obstruction
• Necrosis
• Pancreatitis
• Pancreatitis, Chronic
• Pyloric Stenosis

• NCT number: NCT04813055
• Study type: Observational [Patient Registry]
• Source: IRCCS San Raffaele
• Contact: Giuseppe Vanella, MD
• Phone: +390226439574
• Email: vanella.giuseppe@hsr.it
• Status: Recruiting
• Start date: December 1, 2020
• Completion date: December 1, 2025