Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study

Last updated: May 25, 2023
Sponsor: Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Overall Status: Active - Enrolling

Phase

N/A

Condition

Gastroenteritis

Ulcerative Colitis (Pediatric)

Pancreatitis

Treatment

Therapeutic Endoscopic Ultrasound

Clinical Study ID

NCT05051358
Pro2020002795
  • All Genders

Study Summary

The purpose of this retrospective chart-review registry study is to evaluate the safety profile, efficacy profile and cost-effectiveness of the various therapeutic endoscopic ultrasound (EUS) procedures (for benign and malignant gastrointestinal disorders).

  1. To assess the clinical and technical success rates of EUS-Guided interventions

  2. To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses.

  3. Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures forGastrointestinal indications

Exclusion

Exclusion Criteria:

  • Subjects not undergoing Interventional Therapeutic Endoscopic Ultrasound Proceduresfor Gastrointestinal indications

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: Therapeutic Endoscopic Ultrasound
Phase:
Study Start date:
February 11, 2021
Estimated Completion Date:
December 10, 2023

Study Description

Our tertiary-care institution performs clinically-indicated therapeutic Endoscopic Ultrasound (TEUS) guided interventions, including biliary and pancreatic drainage, for both malignant and benign gastrointestinal indications in more than 2000 patients annually.

Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders.

TEUS procedures are less invasive approach than surgery. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

They improve quality of life and extend survival duration.

Currently, there is limited multi-center data on therapeutic endoscopy clinical outcomes and standardized treatment algorithms in western populations. Due to continuing variations in therapeutic EUS procedures, as well as introduction of some TEUS procedure accessories; it is necessary to periodically evaluate the efficacy and safety of specific TEUS procedures and accessories for several indications to check for improved clinical outcomes.

Evaluation of these clinical details would help us compare them to conventional treatment modalities within our current facility and scope of practice; and consequently, help us identify safe and cost-effective treatment techniques, develop treatment algorithms and improve clinical management of patients at RWJMS and other tertiary-care centers.

Connect with a study center

  • Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

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