IRCCS San Raffaele Scientific Institute
Milan, 20132, Italy
Location status: Recruiting
NCT Number: NCT04813055
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Milan, 20132, Italy
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 (ERCP with stenting; enteral stenting, Enteroscopy-assisted ERCP)
Time frame: 30 days
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
Time frame: 1 day
Completion of the procedure through the correct positioning of the intended device in the target organ
Time frame: 12 months
A new onset or a worsening of the condition which was palliated through the procedure, after an initial clinical success
Contact information is provided by the study sponsor or research team.
Paolo Giorgio Arcidiacono, MD
Other
Acronym: PROTECT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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