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.
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 Type
OBSERVATIONAL
Enrollment
510
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
Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
Surgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy)
Other endoscopic procedures not involving EUS (enteral stenting, Enteroscopy-assisted ERCP)
IRCCS San Raffaele Scientific Institute
Milan, Italy
RECRUITINGClinical 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.
Time frame: 30 days
Adverse events
Any post-procedural complaint or complication requiring medical consultation or additional procedures, stratified according to American Society of Gastrointestinal Endoscopy Lexicon
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.