Prospective Registry Of Therapeutic EndoscopiC ulTrasound

Study Overview
=================
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.

Official Title
-----------------
Prospective Registry Of Therapeutic EndoscopiC ulTrasound

Conditions
-----------------
Gastric Outlet Obstruction, Biliary Obstruction, Acute Pancreatic Fluid Collection, Acute Pancreatitis With Infected Necrosis, Acute Cholecystitis, Chronic Pancreatitis

Intervention / Treatment
-----------------
* Procedure: Therapeutic EUS
* Procedure: Percutaneous Procedures
* Procedure: Surgical Interventions
* Procedure: non-EUS-based endoscopic procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Therapeutic EUS<br>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. | Procedure: Therapeutic EUS<br>* EUS-guided collection drainage (transgastric or transduodenal, performed by Lumen Apposing Metal Stents or double pigtail stents) and eventual endoscopic necrosectomy 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). EUS-guided gallbladder drainage via Lumen Apposing Metal Stents and eventual subsequent EUS-based cholecystolithotomy EUS-guided gastro-jejunostomy through Lumen Apposing Metal Stents EUS-directed ERCP in post-surgical anatomy (by gastro-gastrostomy or entero-enterostomy performed through Lumen Apposing Metal Stents) EUS-guided pancreatic duct drainage<br>|
| Controls<br>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) | Procedure: Percutaneous Procedures<br>* Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)<br>Procedure: Surgical Interventions<br>* Surgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy)<br>Procedure: non-EUS-based endoscopic procedures<br>* Other endoscopic procedures not involving EUS (enteral stenting, Enteroscopy-assisted ERCP)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Any post-procedural complaint or complication requiring medical consultation or additional procedures, stratified according to American Society of Gastrointestinal Endoscopy Lexicon | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic ultrasound, Therapeutic EUS, Interventional EUS, Biliary Drainage, Gastro-jejunostomy, Gallbladder Drainage, Endoscopy