Status:
COMPLETED
Esophageal Dysfunction Associated With Opioids: Clinical Response and Manometric Findings After Opioid Discontinuation
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Vall Hebron Insitut Recerca
Conditions:
Opioid Use
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Background: Opioid-induced esophageal dysfunction is characterized by altered motility of the esophageal body or impaired function of the esophageal sphincters secondary to chronic opioid use. The dia...
Detailed Description
Background and Current State of the Topic Chronic opioid consumption has been increasing significantly in recent years. While the side effects on the small intestine and colon are well-studied and wel...
Eligibility Criteria
Inclusion
- Patients with dysphagia on chronic treatment with opioids referred for study using high-resolution esophageal manometry in our motility laboratory
Exclusion
- Those patients who, due to comorbidities, cannot suspend opioid treatment,
- Patients who do not wish to participate,
- Patients who present any symptoms suggestive of withdrawal or who are not able to suspend opioid treatment due to increased pain or discomfort during the seven days prior to the study
- Patients who have received any definitive treatment for the previously diagnosed motor disorder. (pe. Heller myotomy)
- Patients with gastroesophageal junction surgeries (e.g. Nissen type fundoplication)
- Patients with major esophageal endoscopic procedures (e.g. peroral endoscopic myotomy POEM).
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06522633
Start Date
November 1 2020
End Date
August 31 2024
Last Update
October 9 2024
Active Locations (1)
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1
Hospital Clínic of Barcelona
Barcelona, Spain, 08036