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NCT Number: NCT04813055

Prospective Registry Of Therapeutic EndoscopiC ulTrasound

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.

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Key information

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease
  • subject eligible to T-EUS procedures but undergoing other non-EUS based endoscopic procedures, percutaneous or surgical procedures
  • 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

Treatment and study plan

Therapeutic EUS

Procedure
  • EUS-guided collection drainage (transgastric or transduodenal, performed by Lumen Apposing Metal Stents or double pigtail stents) and eventual endoscopic necrosectomy
  • 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).
  • EUS-guided gallbladder drainage via Lumen Apposing Metal Stents and eventual subsequent EUS-based cholecystolithotomy
  • EUS-guided gastro-jejunostomy through Lumen Apposing Metal Stents
  • EUS-directed ERCP in post-surgical anatomy (by gastro-gastrostomy or entero-enterostomy performed through Lumen Apposing Metal Stents)
  • EUS-guided pancreatic duct drainage

Percutaneous Procedures

Procedure

Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)

Surgical Interventions

Procedure

Surgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy)

non-EUS-based endoscopic procedures

Procedure

Other endoscopic procedures not involving EUS (ERCP with stenting; enteral stenting, Enteroscopy-assisted ERCP)

Primary outcomes

  1. Clinical Success

    Time frame: 30 days

    • EUS-guided collection drainage: Resolution or reduction of > 50% of fluid collections
    • EUS-guided biliary drainage [valid also for ERCP with stenting]: Reduction of >50% 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 [valid also for enteral stenting]: 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.

Secondary outcomes

  1. 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

Other outcomes

  1. Technical success

    Time frame: 1 day

    Completion of the procedure through the correct positioning of the intended device in the target organ

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Vanella, MD

CONTACT

[email protected]

+390226439574

Sponsors and collaborators

Lead sponsor

Paolo Giorgio Arcidiacono, MD

Other

Registry information

Acronym: PROTECT

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2021
Registry last updated
Apr 13, 2026

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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