- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04813055
Prospective Registry Of Therapeutic EndoscopiC ulTrasound (PROTECT)
Study Overview
Status
Conditions
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.
All patients eligible for the abovementioned clinical indications, but finally undergoing alternative procedures (e.g. surgical interventions, percutaneous interventions or other endoscopic procedures) will be proposed to be enrolled in the registry as "controls". The same variables will be collected, with the exception of technical variables related to the EUS-guided intervention.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Giuseppe Vanella, MD
- Phone Number: +390226439574
- Email: vanella.giuseppe@hsr.it
Study Locations
-
-
-
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
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease
- 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?
Design Details
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.
|
|
Controls
Patients eligible for T-EUS procedures, but undergoing alternative surgical interventions, percutaneous interventions (e.g.
Percutaneous Biliary Drainage) or non-EUS based endoscopic procedures (e.g.
enteral stenting)
|
Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
Surgical interventions to obtain a drainage (e.g.
surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy)
Other endoscopic procedures not involving EUS (enteral stenting, Enteroscopy-assisted ERCP)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Success
Time Frame: 30 days
|
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 12 months
|
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
Time Frame: 1 day
|
Completion of the procedure through the correct positioning of the intended device in the target organ
|
1 day
|
Recurrence
Time Frame: 12 months
|
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
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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease Attributes
- Gastrointestinal Diseases
- Stomach Diseases
- Gallbladder Diseases
- Biliary Tract Diseases
- Pancreatic Diseases
- Chronic Disease
- Cholecystitis
- Cholecystitis, Acute
- Necrosis
- Pancreatitis
- Pancreatitis, Chronic
- Pyloric Stenosis
- Gastric Outlet Obstruction
Other Study ID Numbers
- 178/INT/2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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