Prospective Registry Of Therapeutic EndoscopiC ulTrasound

Overview

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.

Interventions

• Procedure 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 eventua
• Procedure Percutaneous Procedures
  Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
• Procedure 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)
• Procedure non-EUS-based endoscopic procedures
  Other endoscopic procedures not involving EUS (ERCP with stenting; enteral stenting, Enteroscopy-assisted ERCP)

Primary outcome measures

• Clinical Success [Time frame: 30 days]

Secondary outcome measures (1)

• Adverse events [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-control

Study locations

Italy · 1 center

• IRCCS San Raffaele Scientific Institute — Milan

Publications

• DeWitt JM, Arain M, Chang KJ, Sharaiha R, Komanduri S, Muthusamy VR, Hwang JH; AGA Center for GI Innovation and Technology. Interventional Endoscopic Ultrasound: Current Status and Future Directions. Clin Gastroenterol Hepatol. 2021 Jan;19(1):24-40. doi: 10.1016/j.cgh.2020.09.029. Epub 2020 Sep 18. PMID 32950747
• Teoh AYB, Dhir V, Kida M, Yasuda I, Jin ZD, Seo DW, Almadi M, Ang TL, Hara K, Hilmi I, Itoi T, Lakhtakia S, Matsuda K, Pausawasdi N, Puri R, Tang RS, Wang HP, Yang AM, Hawes R, Varadarajulu S, Yasuda K, Ho LKY. Consensus guidelines on the optimal management in interventional EUS procedures: results from the Asian EUS group RAND/UCLA expert panel. Gut. 2018 Jul;67(7):1209-1228. doi: 10.1136/gutjnl- PMID 29463614
• Vanella G, Frigo F, Perelli F, Bara R, Maisonneuve P, Archibugi L, Tacelli M, Lauri G, Bellafante D, Bina N, Nunziata R, Biamonte P, Ponz De Leon Pisani R, Capurso G, Arcidiacono PG. The Learning Curve of Junior Endoscopists in EUS-Guided Gastroenterostomy With the Wireless Simplified Technique: A Prospective Study. United European Gastroenterol J. 2026 Mar;14(2):e70170. doi: 10.1002/ueg2.70170. PMID 41820242
• 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. EUS-guided drainage of Post-Surgical versus Post-Pancreatitis collections (the RESPELL study): A prospective comparison o PMID 41577578
• Vanella G, Frigo F, Perelli F, Bara 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. Long-term Outcomes of endoscopic ultrasound-guided Gastroenterostomy (LONG-RANGE study): a prospective cohort study tracking symptom recurrence, reintervention timelines and stent modifications over time. Gastrointest Endosc. PMID 41548724
• Vanella G, Leone R, Frigo F, Bronswijk M, van Wanrooij RLJ, Tamburrino D, Orsi G, Belfiori G, Macchini M, Reni M, Aldrighetti L, Falconi M, Capurso G, van der Merwe S, Arcidiacono PG. Endoscopic ultrasound-guided choledochoduodenostomy versus hepaticogastrostomy combined with gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): A prospective comparative study. DEN Open. 2024 Oct 6;5( PMID 39377069

Identifiers

NCT: NCT04813055 · PROTECT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗