NCT04813055

Prospective Registry Of Therapeutic EndoscopiC ulTrasound

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 510 (estimated)
• Sponsor: Paolo Giorgio Arcidiacono, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. The study also includes standard alternatives to T-EUS procedures for outcomes comparison.

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

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Therapeutic EUS	1. EUS-guided collection drainage (transgastric or transduodenal, performed by Lumen Apposing Metal Stents or double pigtail stents) and eventual endoscopic necrosectomy 2. EUS-guided biliary drainage (either of the extrahepatic or intrahepatic biliary tree / transduodenal or transgastric / either as access for subsequent rendez-vous or transpapillary stenting OR for transparietal stenting by metal or plastic stents). 3. EUS-guided gallbladder drainage via Lumen Apposing Metal Stents and eventual subsequent EUS-based cholecystolithotomy 4. EUS-guided gastro-jejunostomy through Lumen Apposing Metal Stents 5. EUS-directed ERCP in post-surgical anatomy (by gastro-gastrostomy or entero-enterostomy performed through Lumen Apposing Metal Stents) 6. EUS-guided pancreatic duct drainage
PROCEDURE	Percutaneous Procedures	Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
PROCEDURE	Surgical Interventions	Surgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy)
PROCEDURE	non-EUS-based endoscopic procedures	Other endoscopic procedures not involving EUS (ERCP with stenting; enteral stenting, Enteroscopy-assisted ERCP)

Timeline

• Start date: 2020-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-31
• First posted: 2021-03-24
• Last updated: 2026-04-13

Locations

1 site across 1 country: Italy