Prospective Registry Of Therapeutic EndoscopiC ulTrasound (PROTECT)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pancreatitis; Gastric Outlet Obstruction; Acute Cholecystitis; Biliary Obstruction; Acute Pancreatic Fluid Collection; Acute Pancreatitis With Infected Necrosis
• Intervention / Treatment: Procedure: Therapeutic EUS; Procedure: Percutaneous Procedures; Procedure: Surgical Interventions; Procedure: non-EUS-based endoscopic procedures

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.

• Study Type: Observational
• Enrollment (Estimated): 510

Contacts and Locations

• Study Contact: Name: Giuseppe Vanella, MD; Phone Number: +390226439574; Email: vanella.giuseppe@hsr.it

Study Locations

• Italy
  • Milan, Italy, 20132
    • Recruiting
    • IRCCS San Raffaele Scientific Institute
    • Contact: Giuseppe Vanella, MD; Phone Number: +390226439574; Email: vanella.giuseppe@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All consecutive patients referred for any condition treatable by therapeutic EUS procedures, benign or malignant, as first intention or after failure of other procedures.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Therapeutic EUS; 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; EUS-guided collection drainage (transgastric or transduodenal, performed by Lumen Apposing Metal Stents or double pigtail stents) and eventual endoscopic necrosectomy; 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).; EUS-guided gallbladder drainage via Lumen Apposing Metal Stents and eventual subsequent EUS-based cholecystolithotomy; EUS-guided gastro-jejunostomy through Lumen Apposing Metal Stents; EUS-directed ERCP in post-surgical anatomy (by gastro-gastrostomy or entero-enterostomy performed through Lumen Apposing Metal Stents); EUS-guided pancreatic duct drainage
Controls; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Completion of the procedure through the correct positioning of the intended device in the target organ	1 day
Recurrence	A new onset or a worsening of the condition which was palliated through the procedure, after an initial clinical success	12 months

Collaborators and Investigators

• Sponsor: Paolo Giorgio Arcidiacono, MD
• Investigators: Principal Investigator: Paolo Giorgio Arcidiacono, MD, FASGE, IRCCS San Raffaele Scientific Institute

Publications and helpful links

General 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.
• 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-2017-314341. Epub 2018 Feb 20.
• 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(1):e70024. doi: 10.1002/deo2.70024. eCollection 2025 Apr.
• 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.
• 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 of clinical presentations and therapeutic outcomes. Dig Liver Dis. 2026 Apr;58(4):493-502. doi: 10.1016/j.dld.2026.01.010. Epub 2026 Jan 22.
• 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. 2026 Jan 16:S0016-5107(26)00034-9. doi: 10.1016/j.gie.2026.01.007. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 21, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Endoscopy; Endoscopic ultrasound; Gallbladder Drainage; Biliary Drainage; Therapeutic EUS; Interventional EUS; Gastro-jejunostomy
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pancreatic Diseases; Biliary Tract Diseases; Gallbladder Diseases; Pathological Conditions, Signs and Symptoms; Cholecystitis; Pancreatitis; Pancreatitis, Chronic; Cholecystitis, Acute; Gastric Outlet Obstruction; Surgical Procedures, Operative
• Other Study ID Numbers: PROTECT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No