Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

Active, not recruiting

• Conditions: Hirschsprung's Disease; Spastic Esophageal Disorders; Zenker's Diverticulum; Esophageal Obstruction; Gastroparesis; Gastrointestinal Neoplasia

• Registration Number: NCT03626350
• Lead Sponsor: University of Colorado, Denver

Brief Summary

To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker's diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung's Disease, and Gastrointestinal neoplasia.

The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria.

A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-12
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2025-06-12
• Study Completion: 2025-06-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Patients who will undergo submucosal endoscopy
2. Age >18 years

Exclusion Criteria

1. Age <18 years
2. Pregnancy
3. Coagulopathy (platelets less than 50, INR more than 1.8)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events	baseline to one year	as defined by published ASGE criteria
Technical and clinical success in performing submucosal endoscopy	baseline to one year	Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology.

Secondary Outcome Measures

Name	Time	Method
Procedure time	During procedure	Procedure time
Submucosal endoscopy technique and device used	During procedure	Submucosal endoscopy technique and device used

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States