NCT04813055

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Dec 2020Dec 2026

Study Start

First participant enrolled

December 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

6 years

First QC Date

March 21, 2021

Last Update Submit

April 10, 2026

Conditions

Gastric Outlet ObstructionAcute Pancreatitis With Infected NecrosisBiliary ObstructionAcute Pancreatic Fluid CollectionAcute CholecystitisChronic Pancreatitis

Keywords

Endoscopic ultrasoundTherapeutic EUSInterventional EUSBiliary DrainageGastro-jejunostomyGallbladder DrainageEndoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse events

    12 months

Other Outcomes (2)

  • Technical success

    1 day

  • Recurrence

    12 months

Study Arms (2)

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

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 ProceduresProcedure: Surgical InterventionsProcedure: non-EUS-based endoscopic procedures

Interventions

Surgical InterventionsPROCEDURE

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

Controls
Therapeutic EUSPROCEDURE

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

Therapeutic EUS
Percutaneous ProceduresPROCEDURE

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

Controls
non-EUS-based endoscopic proceduresPROCEDURE

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

Controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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
  • years old or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

RECRUITING

Related Publications (6)

  • 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: 32950747BACKGROUND

  • 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.

    PMID: 29463614BACKGROUND

  • 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: 41820242DERIVED

  • 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.

    PMID: 41577578DERIVED

  • 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.

    PMID: 41548724DERIVED

  • 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.

    PMID: 39377069DERIVED

MeSH Terms

Conditions

Gastric Outlet ObstructionCholecystitis, AcutePancreatitis, Chronic

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesCholecystitisGallbladder DiseasesBiliary Tract DiseasesPancreatitisPancreatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Paolo Giorgio Arcidiacono, MD, FASGE

    IRCCS San Raffaele Scientific Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Vanella, MD

CONTACT

+390226439574vanella.giuseppe@hsr.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 21, 2021

First Posted

March 24, 2021

Study Start

December 1, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

IT(1)