The aim of this project is to identify if EndoFLIP can categorize and change the diagnosis in patients with EGJOO and if categorization with EndoFLIP can predict the response to treatment with botulinum toxin at 12 weeks post procedure. Our hypothesis is that there will be greater symptom resolution in the treatment versus control in the abnormal DI category. In addition, we hypothesize there will be less symptom resolution in the control group with an abnormal DI as compared to those with a normal DI who also receive no treatment.
Esophagogastric Outflow Obstruction (EGJOO) is a newer diagnosis in which some patients' symptoms resolve spontaneously or with conservative treatment, while others require treatment with botulinum toxin injected into the lower esophageal sphincter. Currently, there is no way to distinguish these two groups of patients upon diagnosis. EndoFLIP (endolumenal functional lumen imaging probe) is a new technology that can measure the distensibility index (DI) of the lower esophageal sphincter. Data has suggested that normal and abnormal DI measurements can categorize these patients and guide treatment course (1). Our study looks to confirm this finding. 1\. Elsbernd et al. Clinical characteristics and treatment response of esophagogastric junction outflow obstruction. Gastroenterology 2019;156(6):S-1017.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant).
Symptom Resolution
The primary endpoint is the proportion of patients with complete symptom resolution at 12 weeks (Eckardt score \< 3) post procedure in each group.
Time frame: 12 weeks.
Percent change in symptom score
The secondary endpoint is the percent change in symptom score at 12 weeks in each group.
Time frame: 12 weeks.
Mean symptom scores
The secondary endpoint is the change in mean symptom score in each group at 12 weeks.
Time frame: 12 weeks.
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