Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588348
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Corticosteroid Effect on Achalasia Variant EGJOO
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Corticosteroid Effect on Achalasia Variant Esophagogastric Junction Outflow Obstruction
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
EGJOO is a disorder in which the muscles of the esophagus swallowing tube do not function in a coordinated fashion so that swallowed material does not pass easily into the stomach EGJOO often causes symptoms of swallowing difficulties and chest pain The cause of EGJOO and its optimal treatment are not clear The investigators research team suspects that EGJOO might be caused by an allergy that involves the esophagus and that treatment with medications called corticosteroids might improve function of the esophageal muscles The purpose of this study is to learn how corticosteroid therapy affects the muscles of the esophagus in patients suffering with EGJOO
Detailed Description:
Esophagogastric junction outflow obstruction EGJOO is an esophageal motility disorder with a heterogeneous etiology The optimal treatment for EGJOO is not known and proper management of the condition remains disputed Similar to patients with achalasia patients with EGJOO exhibit poor relaxation of the lower esophageal sphincter LES with swallowing Unlike patients with achalasia however those with EGJOO have some intact peristalsis in the esophageal body Achalasia treatments pneumatic dilation Heller myotomy per-oral endoscopic myotomy POEM attempt to destroy LES muscle contraction function with myotomy inflicted by balloon distention pneumatic dilation diathermic needle-knife POEM or scalpel Heller myotomy With POEM and Heller myotomy the incision extends into muscle of the esophageal body These same interventions have been used to treat EGJOO but an effective non-invasive therapy that does not involve muscle disruption would be preferable especially since EGJOO patients have evidence of esophageal body peristalsis that might be destroyed by achalasia myotomy techniques The investigators Center for Esophageal Diseases has recently described a possible allergic etiology for achalasia and EGJOO in a study in which the investigators found profound mast cell degranulation in the LES muscle in all of 13 patients with these disorders who were treated with Heller myotomy The investigators have also published reports outlining the investigators rationale for considering an allergic etiology for achalasia and EGJOO Now an extension of this work is to assess whether corticosteroid therapy which can improve allergic conditions can correct the esophageal dysfunction in EGJOO to the point that invasive and irreversible myotomy treatments might not be required The proposed study will enroll subjects with clinically significant EGJOO on the achalasia-variant spectrum and treat them with a 14-day course of oral systemic corticosteroid therapy The investigators aim to describe the symptomatic and manometric response to corticosteroid therapy and hypothesize that the investigators findings might establish that a subset of patients with EGJOO have a reversible form of esophageal muscle dysfunction Although long-term treatment with corticosteroids has unacceptable toxicity identification of a reversible form of EGJOO with a short course of steroid therapy would suggest a therapeutic role for other less toxic allergy-directed therapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None