An observational study in Gastric Outlet Obstruction, Biliary Obstruction and Acute Pancreatic Fluid Collection, sponsored by Paolo Giorgio Arcidiacono, MD. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Paolo Giorgio Arcidiacono, MD · Observational
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.
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:
Each patient will be assigned to a procedure following standard clinical practice, in most instances following a routinely multidisciplinary discussion.
Patients eligible for the abovementioned clinical indications, but undergoing alternative procedures (e.g. other endoscopic procedures, surgical interventions or percutaneous interventions) will be enrolled in the registry as "controls" according to specific research questions.
The same variables will be collected, with the exception of technical variables related to the EUS-guided intervention.
38 studies on the registry are indexed under Gastric Outlet Obstruction; 14 are open to participants now.
Browse Gastric Outlet Obstruction studies →Paolo Giorgio Arcidiacono, MD is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients referred for any condition treatable by therapeutic EUS procedures, benign or malignant, as first intention or after failure of other procedures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients eligible for T-EUS procedures, but undergoing non-EUS based endoscopic procedures (e.g. ERCP or enteral stenting), surgical interventions or percutaneous interventions (e.g. Percutaneous Biliary Drainage)
Procedure: Percutaneous Procedures · Procedure: Surgical Interventions · Procedure: non-EUS-based endoscopic procedures
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 (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.
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
Technical success
Completion of the procedure through the correct positioning of the intended device in the target organ
Time frame: 1 day
Recurrence
A new onset or a worsening of the condition which was palliated through the procedure, after an initial clinical success
Time frame: 12 months
Started Dec 2020 (actual). Primary completion is estimated for Dec 2026, 72 months after the start.
How these figures are worked out, and which studies are left out of them.
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Paolo Giorgio Arcidiacono, MD