Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study

Gastrointestinal Cancer Clinical Trial

— TEUS Registry  

Official title:

Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05051358
• Other study ID #: Pro2020002795
• Status: Enrolling by invitation
• Start date: February 11, 2021
• Est. completion date: December 10, 2023

Study information

• Verified date: May 2023
• Source: Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Diseases
• Digestive System Diseases
• Digestive System Fistula
• Fistula
• Gastro-Intestinal Disorder
• Gastrointestinal Cancer
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gastrointestinal Dysfunction
• Gastrointestinal Fistula
• Gastrointestinal Infection
• Gastrointestinal Injury
• Gastrointestinal Neoplasms
• Intestinal Diseases
• Pancreatic Disease
• Pancreatic Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Procedure	Technical and clinical success rates	Upto 2 years
Primary	Safety of procedure	Type, frequency and intensity of adverse events	Upto 2 years
Secondary	Cost Effectiveness	Total cost associated with procedures	Upto 2 years