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.
subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease
subject eligible to T-EUS procedures but undergoing other non-EUS based endoscopic procedures, percutaneous or surgical procedures
18 years old or older
able to provide an informed consent to inclusion.
age < 18 years
inability or unwillingness to sign the informed consent form (ICF)
contra-indication for endoscopy or use of fluoroscopy
All consecutive patients referred for any condition treatable by therapeutic EUS procedures, benign or malignant, as first intention or after failure of other procedures.
Case-control
Prospective
Therapeutic EUS
Procedure/Surgery1. 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
Procedure/SurgeryProcedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
Surgical Interventions
Procedure/SurgerySurgical 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
Procedure/SurgeryOther endoscopic procedures not involving EUS (ERCP with stenting; enteral stenting, Enteroscopy-assisted ERCP)
Clinical Success
* 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.
Adverse events
Any post-procedural complaint or complication requiring medical consultation or additional procedures, stratified according to American Society of Gastrointestinal Endoscopy Lexicon
Technical success
Completion of the procedure through the correct positioning of the intended device in the target organ
Recurrence
A new onset or a worsening of the condition which was palliated through the procedure, after an initial clinical success
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Paolo Giorgio Arcidiacono, MD
Lead sponsor
IRCCS San Raffaele
Sponsor institution
