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Not Yet Recruiting NCT07930143

EndoFLIP-Guided Initial Management of Esophagogastric Junction Outflow Obstruction

Conditions: Esophagogastric Junction Outflow Obstruction

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 115
Sponsor: Hospital Clinic of Barcelona

Location: Hospital Clínic de Barcelona Barcelona Barcelona

Summary

Esophagogastric junction outflow obstruction (EGJOO) can make it difficult for food to pass from the esophagus into the stomach. Some people improve without a procedure to treat the obstruction, while others have persistent swallowing difficulties and may need further treatment. The O-FLIP study tests whether measurements taken during an endoscopy with a tool called EndoFLIP can help doctors choose an initial treatment for adults with EGJOO. The main outcome is improvement in swallowing symptoms three months after initial management. The study will also track how long improvement lasts and how many participants need further treatment over one year.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older. * Written study-specific informed consent. * Clinically relevant dysphagia, defined as a Brief Esophageal Dysphagia Questionnaire (BEDQ) score of at least 8. * High-resolution manometry findings consistent with esophagogastric junction outflow obstruction (EGJOO) according to Chicago Classification version 4.0: elevated median integrated relaxation pressure in both the supine and upright positions, evidence of peristalsis, and intrabolus pressure greater than 20 mmHg in at least 20% of supine swallows, without meeting criteria for achalasia. Premature or hypercontractile contractions are permitted when peristalsis is present and criteria for type III achalasia are not met. Exclusion Criteria: * Prior surgery or treatment directed at the esophagogastric junction, including botulinum toxin injection, pneumatic dilation, peroral endoscopic myotomy (POEM), Heller myotomy, or fundoplication. * Current opioid use unless opioids can be discontinued for at least 1 week before enrollment. * Hiatal hernia larger than 3 cm, peptic stricture, esophageal rings, esophagogastric malignancy, or any other mechanical cause of dysphagia. This includes a mechanical cause detected during the index endoscopy before EndoFLIP. * Eosinophilic esophagitis. * Systemic or infectious disease that significantly affects esophageal motility, such as systemic sclerosis or Chagas disease. * Inability to complete the planned clinical follow-up.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07930143). StuddyBuddy aggregates publicly available trial information.