Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study (TEUS Registry)

Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gastrointestinal Dysfunction; Bile Duct Diseases; Gastrointestinal Cancer; Gastrointestinal Disease; Pancreatic Disease; Gastrointestinal Infection; Gastrointestinal Fistula; Gastro-Intestinal Disorder; Gastrointestinal Injury; Therapeutic Endoscopic Ultrasound; Advanced Endoscopy; Therapeutic Endoscopy; Interventional Endoscopy; Interventional Endoscopic Ultrasound
• Intervention / Treatment: Procedure: Therapeutic Endoscopic Ultrasound

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications

Description

Inclusion Criteria:

• Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications

Exclusion Criteria:

• Subjects not undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Subjects undergoing Therapeutic Endoscopic Ultrasound; Procedures that will be captured include: EUS- ERCP, Endoscopic Hepatology - EUS, EUS-Coils placement, EUS Glue injection, EUS-Fiducial placement, EUS-Neurolysis, EUS-Stent placement, EUS-alcohol injection, EUS-guided Ablation, EUS-guided anastomosis, EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage, EUS guided - Hemostasis, EUS guided- Therapy for cancer or premalignant lesion (Injection, neurolysis, fiducial, aspiration, RFA ), EUS - Fluid Collection, abscess or cavity drainage, EUS - Guided Ductal Drainage, EUS - Guided Anastomosis

Procedure: Therapeutic Endoscopic Ultrasound; Therapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Procedure	Technical and clinical success rates	Upto 2 years
Safety of procedure	Type, frequency and intensity of adverse events	Upto 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Effectiveness	Total cost associated with procedures	Upto 2 years

Collaborators and Investigators

• Sponsor: Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
• Investigators: Principal Investigator: Michel Kahaleh, MD, Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Estimated): December 10, 2023
• Study Completion (Estimated): December 10, 2023

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Pathological Conditions, Anatomical; Biliary Tract Diseases; Fistula; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Intestinal Diseases; Pancreatic Diseases; Bile Duct Diseases; Digestive System Fistula
• Other Study ID Numbers: Pro2020002795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be made available to other out-of-site researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No