NCT02855151

Brief Summary

The aim of the EUS registry is to record information about Endoscopic Ultrasound (EUS) on the management of gastrointestinal disease. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS). Design is retrospective and prospective registry study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

9.9 years

First QC Date

July 18, 2016

Last Update Submit

June 15, 2020

Conditions

Keywords

EUS

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related adverse events

    Documentation of adverse events.

    2 days

Secondary Outcomes (3)

  • Diagnostic yied of elastography during EUS

    0 Day

  • Diagnostic yied of Contrast-Enhanced Endoscopic Ultrasonography

    0 Day

  • Tissue acquisition during EUS

    0 Days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients submitted to diagnostic or therapeutic EUS

You may qualify if:

  • All patients submitted to EUS,
  • Informed consent.

You may not qualify if:

  • Age less than 18 y
  • Patient who did not give the consent to the processing of personal data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

Related Publications (2)

  • Carrara S, Rahal D, Khalaf K, Rizkala T, Koleth G, Bonifacio C, Andreozzi M, Mangiavillano B, Auriemma F, Bossi P, Balzarotti M, Facciorusso A, Staiano T, Maldi E, Spadaccini M, Colombo M, Fugazza A, Maselli R, Hassan C, Repici A. Diagnostic accuracy and safety of EUS-guided end-cutting fine-needle biopsy needles for tissue sampling of abdominal and mediastinal lymphadenopathies: a prospective multicenter series. Gastrointest Endosc. 2023 Aug;98(2):191-198. doi: 10.1016/j.gie.2023.03.018. Epub 2023 Mar 27.

  • Carrara S, Di Leo M, Grizzi F, Correale L, Rahal D, Anderloni A, Auriemma F, Fugazza A, Preatoni P, Maselli R, Hassan C, Finati E, Mangiavillano B, Repici A. EUS elastography (strain ratio) and fractal-based quantitative analysis for the diagnosis of solid pancreatic lesions. Gastrointest Endosc. 2018 Jun;87(6):1464-1473. doi: 10.1016/j.gie.2017.12.031. Epub 2018 Jan 9.

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Alessandro Repici, MD

    Humanitas University

    PRINCIPAL INVESTIGATOR
  • Silvia Carrara, MD

    Humanitas Cancer Center

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

August 4, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations