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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic EUS | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success |
| 30 days |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients referred for any condition treatable by therapeutic EUS procedures, benign or malignant, as first intention or after failure of other procedures.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Vanella, MD | Contact | +390226439574 | vanella.giuseppe@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Giorgio Arcidiacono, MD, FASGE | IRCCS San Raffaele Scientific Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Scientific Institute | Recruiting | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32950747 | Background | 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. | |
| 29463614 | Background |
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|
| Percutaneous Procedures | Procedure | Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree) |
|
| Surgical Interventions | Procedure | Surgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy) |
|
| non-EUS-based endoscopic procedures | Procedure | Other endoscopic procedures not involving EUS (ERCP with stenting; enteral stenting, Enteroscopy-assisted ERCP) |
|
| 12 months |
| 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. |
| 41820242 | Derived | 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. |
| 41577578 | Derived | 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. |
| 41548724 | Derived | 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. |
| 39377069 | Derived | 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. |
| ID | Term |
|---|---|
| D017219 | Gastric Outlet Obstruction |
| D041881 | Cholecystitis, Acute |
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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