Prospective Registry Of Therapeutic EndoscopiC ulTrasound

Conditions

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

Keywords

Endoscopic ultrasound, Therapeutic EUS, Interventional EUS, Biliary Drainage, Gastro-jejunostomy, Gallbladder Drainage, Endoscopy

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. The study also includes standard alternatives to T-EUS procedures for outcomes comparison.

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. 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.

Vanella G, Frigo F, Leone R, Rossi G, Zaccari P, Stasio RC, Archibugi L, Petrone MC, Tacelli M, Palumbo D, Guazzarotti G, Bronswijk M, van Wanrooij RLJ, Guarneri G, Tamburrino D, Preatoni P, Ratti F, Catena M, Van der Merwe S, Falconi M, Capurso G, De Cobelli F, Arcidiacono PG.

2026-01-22

10.1016/j.dld.2026.01.010

Long-term Outcomes of EUS-guided Gastroenterostomy (LONG-RANGE study): a prospective cohort study tracking symptom recurrence, reintervention timelines and stent modifications over time.

Vanella G, Frigo F, Perelli F, Barà R, Leone R, Stasio RC, Maisonneuve P, Partelli S, Aleotti F, Orsi G, Macchini M, Balzano G, Reni M, Falconi M, Capurso G, Arcidiacono PG.

2026-01-16

10.1016/j.gie.2026.01.007

Predicting the need for step-up after EUS-guided drainage of peripancreatic fluid collections, including Quadrant-Necrosis-Infection score validation: a prospective cohort study.

Vanella G, Leone R, Frigo F, Rossi G, Zaccari P, Palumbo D, Guazzarotti G, Aleotti F, Pecorelli N, Preatoni P, Aldrighetti L, Falconi M, Capurso G, De Cobelli F, Arcidiacono PG.

2025-01-203 citations

10.1016/j.gie.2025.01.019

Endoscopic ultrasound‐guided choledochoduodenostomy versus hepaticogastrostomy combined with gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): A prospective comparative study

Giuseppe Vanella, Roberto Leone, Francesco Frigo, Michiel Bronswijk, Roy L.J. van Wanrooij et al. (15 authors)

DEN Open2024-10-0612 citations

10.1002/deo2.70024

EUS-guided gastroenterostomy for management of malignant gastric outlet obstruction: a prospective cohort study with matched comparison with enteral stenting.

Vanella G, Dell'Anna G, Capurso G, Maisonneuve P, Bronswijk M, Crippa S, Tamburrino D, Macchini M, Orsi G, Casadei-Gardini A, Aldrighetti L, Reni M, Falconi M, van der Merwe S, Arcidiacono PG.

2023-04-2354 citations

10.1016/j.gie.2023.04.2072

Interventions

PROCEDURETherapeutic 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

PROCEDUREPercutaneous Procedures

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

PROCEDURESurgical Interventions

Surgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy)

PROCEDUREnon-EUS-based endoscopic procedures

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* 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.

Exclusion criteria

* age \< 18 years * inability or unwillingness to sign the informed consent form (ICF) * contra-indication for endoscopy or use of fluoroscopy

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

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

Countries

Italy

Contacts

CONTACTGiuseppe Vanella, MD

vanella.giuseppe@hsr.it+390226439574

PRINCIPAL_INVESTIGATORPaolo Giorgio Arcidiacono, MD, FASGE

IRCCS San Raffaele Scientific Institute

Outcome results

None listed