Prospective Registry Of Therapeutic EndoscopiC ulTrasound (PROTECT)

February 22, 2024 updated by: Paolo Giorgio Arcidiacono, MD
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.

Study Overview

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

Observational

Enrollment (Estimated)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Milan, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele Scientific Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
  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
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
  • EUS-guided collection drainage: Resolution or reduction of > 50% of fluid collections
  • EUS-guided biliary drainage: Reduction of >25% 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: 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 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paolo Giorgio Arcidiacono, MD, FASGE, IRCCS San Raffaele Scientific Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 21, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

September 1, 2023

More Information

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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