Prospective Registry Of Therapeutic EndoscopiC ulTrasound

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Percutaneous Procedures: Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)

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)

non-EUS-based endoscopic procedures: Other endoscopic procedures not involving EUS (ERCP with stenting; enteral stenting, Enteroscopy-assisted ERCP)

Study 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.

Eligibility

Primary outcome measure(s)

• Clinical Success — 30 days
  * EUS-guided collection drainage: Resolution or reduction of \> 50% of fluid collections * EUS-guided biliary drainage \[valid also for ERCP with stenting\]: Reduction of \>50% 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 \[valid also for enteral stenting\]: 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.

Trial sites (1)

Other trials for the same condition