Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study

• Conditions: Therapeutic Endoscopic Ultrasound; Advanced Endoscopy; Therapeutic Endoscopy; Gastrointestinal Injury; Bile Duct Diseases; Gastro-Intestinal Disorder; Gastrointestinal Dysfunction; Interventional Endoscopy; Interventional Endoscopic Ultrasound; Gastrointestinal Disease
• Interventions: Procedure: Therapeutic Endoscopic Ultrasound

• Registration Number: NCT05051358
• Lead Sponsor: Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Brief 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.

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 Timeline

• Study Start: 2021-02-11
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26
• Primary Completion: 2023-12-10
• Study Completion: 2023-12-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects undergoing Therapeutic Endoscopic Ultrasound	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

Primary Outcome Measures

Name	Time	Method
Efficacy of Procedure	Upto 2 years	Technical and clinical success rates
Safety of procedure	Upto 2 years	Type, frequency and intensity of adverse events

Secondary Outcome Measures

Name	Time	Method
Cost Effectiveness	Upto 2 years	Total cost associated with procedures

Trial Locations

Locations (1)

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University; 🇺🇸 New Brunswick, New Jersey, United States