GI Tract DisordersNCT02855151
EUS for Gastrointestinal Disorders: a Registry
An observational study of GI Tract Disorders and Pancreatic Disorders, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GI Tract Disorders, Pancreatic Disorders, EUS
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Dec 2022
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients submitted to diagnostic or therapeutic EUS
Who may be able to join
- All patients submitted to EUS,
- Informed consent.
Who cannot join
- Age less than 18 y
- Patient who did not give the consent to the processing of personal data.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, 20089
Alessandro Repici, MD, +39282247493, alessandro.repici@humanitas.it
Alessandro Repici, MD
About this study
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.
- Conditions
- GI Tract Disorders, Pancreatic Disorders, EUS
- Keywords
- EUS
- Medical subject headings
- Pancreatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events
Documentation of adverse events.
Measured: 2 days
Secondary outcomes (3)
Diagnostic yied of elastography during EUS
sensitivity and specificity of EUS with elastography
Measured: 0 Day
Diagnostic yied of Contrast-Enhanced Endoscopic Ultrasonography
sensitivity and specificity contrast medium
Measured: 0 Day
Tissue acquisition during EUS
sensitivity and specificity of tissue acquisition
Measured: 0 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GI Tract DisordersStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Repici, MD, Principal investigator, Humanitas UniversitySilvia Carrara, MD, Study director, Humanitas Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855151
- Sponsor's protocol ID
- 1497
- Status last verified
- Jun 2020
- First submitted
- 18 Jul 2016
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36990125Carrara 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.
PubMed 29329992
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS for Gastrointestinal Disorders: a Registry
- ClinicalTrials.gov ID
- NCT02855151
- Acronym / sponsor ID
- 1497
- Conditions
- GI Tract Disorders, Pancreatic Disorders, EUS
- Keywords
- EUS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients submitted to diagnostic or therapeutic EUS
Key inclusion criteria (2 listed)
- All patients submitted to EUS,
- Informed consent.
Key exclusion criteria (2 listed)
- Age less than 18 y
- Patient who did not give the consent to the processing of personal data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with treatment-related adverse events
Time frame: 2 days
Documentation of adverse events.
3 secondary outcomes
Diagnostic yied of elastography during EUS
Time frame: 0 Day
Diagnostic yied of Contrast-Enhanced Endoscopic Ultrasonography
Time frame: 0 Day
Tissue acquisition during EUS
Time frame: 0 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Derived from this study: PubMed 36990125Carrara 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.
- Derived from this study: PubMed 29329992Carrara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Repici, MD principal investigator
Humanitas University
Silvia Carrara, MD study director
Humanitas Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GI Tract Disorders and Pancreatic Disorders, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Carrara, MD (+390282247288, silvia.carrara@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02855151, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.