Prospective Registry Of Therapeutic EndoscopiC ulTrasound

Recruiting

• Conditions: Acute Cholecystitis; Biliary Obstruction; Acute Pancreatitis With Infected Necrosis; Gastric Outlet Obstruction; Acute Pancreatic Fluid Collection; Chronic Pancreatitis
• Interventions: Procedure: Percutaneous Procedures; Procedure: Therapeutic EUS; Procedure: Surgical Interventions; Procedure: non-EUS-based endoscopic procedures

• Registration Number: NCT04813055
• Lead Sponsor: Paolo Giorgio Arcidiacono, MD

Brief 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.

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.

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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-03-21
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 510

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Percutaneous Procedures	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)
Controls	non-EUS-based endoscopic procedures	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)
Therapeutic EUS	Therapeutic EUS	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.
Controls	Surgical Interventions	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)

Primary Outcome Measures

Name	Time	Method
Clinical Success	30 days	* EUS-guided collection drainage: Resolution or reduction of \> 50% of fluid collections; * EUS-guided biliary drainage: Reduction of \>25% of bilirubin OR management of choledocholithiasis OR resolution of cholangitis; * EUS-guided gallbladder drainage: Improvement of clinical symptoms or relief of inflammatory signs/symptoms related to cholecystitis; * EUS-guided gastro-jejunostomy: Resumption of oral intake (Gastric Outlet Obstruction Scoring System \>/= 2 id est at least semisolid food); * EUS-directed ERCP: Possibility to perform ERCP; * EUS-guided pancreatic duct drainage: Relief of abdominal pain and reduction of analgesic drug requirement during follow-up OR reduction in the rate of recurrent pancreatitis.

Secondary Outcome Measures

Name	Time	Method
Adverse events	12 months	Any post-procedural complaint or complication requiring medical consultation or additional procedures, stratified according to American Society of Gastrointestinal Endoscopy Lexicon

Trial Locations

Locations (1)

IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Italy