Clinical trial NCT03626350: Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy
Official title: Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastrointestinal Neoplasia
Hirschsprung's Disease
Esophageal Obstruction
Gastroparesis
Spastic Esophageal Disorders
Zenker's Diverticulum
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective database/registry of patients undergoing submucosal endoscopic procedures will be formed. Women and minorities will be included as they are frequently found to have indications for which submucosal endoscopic procedures may be indicated.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Technical and clinical success in performing submucosal endoscopy
timeFrame: baseline to one year
measure: Adverse Events
timeFrame: baseline to one year
Secondary outcomes:
measure: Procedure time
timeFrame: During procedure
measure: Submucosal endoscopy technique and device used
timeFrame: During procedure
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
References: