Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy



Status:Enrolling by invitation
Conditions:Gastrointestinal, Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 89
Updated:8/18/2018
Start Date:June 12, 2018
End Date:June 12, 2025

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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.


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)
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