Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522633
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-30
Brief Title:
Esophageal Dysfunction Associated With Opioids Clinical Response and Manometric Findings After Opioid Discontinuation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Evaluation of Opioid Withdrawal in Patients With Suspected Opioid-induced Esophageal Dysfunction OIED
Status:
COMPLETED
Status Verified Date:
2024-10
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:
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 diagnosis of this condition is made through high-resolution manometry Following the discontinuation of opioid treatment most patients experience a clear symptomatic improvement
Hypothesis Opioids induce alterations in esophageal motility and esophageal sphincter function that revert after discontinuation of treatment
Outcome To demonstrate through high-resolution esophageal manometry that the manometric alterations described in patients with chronic opioid use are secondary to opioid consumption and disappear after discontinuing use
Methods In a group of patients with chronic opioid use and diagnosed with a major esophageal motor disorder through high-resolution esophageal manometry a new high-resolution manometry will be performed after discontinuing opioid treatment for at least 7 days to assess any changes compared to the previous manometry
The treating physician will be contacted to inform them about the manometry findings and to consider the possibility of discontinuing opioid treatment Patients will be informed about the association between opioids and esophageal motor disorders and the benefits of discontinuing the medication to evaluate the resolution of symptoms and the observed disorder
To avoid complications such as withdrawal syndrome or exacerbation of pain due to the reduction of analgesic medication an alternative medication protocol will be used according to the recommendations of the psychiatry team associated with functional digestive disorders
Relevance This project will determine whether the manometric alterations are primary or secondary to opioid treatment If it is confirmed that they are secondary to the treatment opioid treatment can be replaced with another analgesic treatment and esophageal symptoms will improve without the need for more aggressive therapies
Hypothesis Opioids induce alterations in esophageal motility and esophageal sphincter function that revert after discontinuation of treatment
Outcome To demonstrate through high-resolution esophageal manometry that the manometric alterations described in patients with chronic opioid use are secondary to opioid consumption and disappear after discontinuing use
Methods In a group of patients with chronic opioid use and diagnosed with a major esophageal motor disorder through high-resolution esophageal manometry a new high-resolution manometry will be performed after discontinuing opioid treatment for at least 7 days to assess any changes compared to the previous manometry
The treating physician will be contacted to inform them about the manometry findings and to consider the possibility of discontinuing opioid treatment Patients will be informed about the association between opioids and esophageal motor disorders and the benefits of discontinuing the medication to evaluate the resolution of symptoms and the observed disorder
To avoid complications such as withdrawal syndrome or exacerbation of pain due to the reduction of analgesic medication an alternative medication protocol will be used according to the recommendations of the psychiatry team associated with functional digestive disorders
Relevance This project will determine whether the manometric alterations are primary or secondary to opioid treatment If it is confirmed that they are secondary to the treatment opioid treatment can be replaced with another analgesic treatment and esophageal symptoms will improve without the need for more aggressive therapies
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 well-established their effects on the upper gastrointestinal tract are not fully understood despite patients reporting numerous symptoms such as dysphagia nausea or chest pain Recently a new entity known as opioid-induced esophageal dysfunction has been described defined as a motility disorder of the esophageal body or dysfunction of the sphincters in patients with chronic opioid use Within this entity the following motor disorders have been primarily observed outflow tract obstruction distal esophageal spasm type III achalasia and Jackhammer esophagus However more studies are needed to determine the prevalence of opioid-induced esophageal dysfunction in chronic opioid users as well as to understand if opioids can cause other esophageal motor disorders besides those described Although an association between chronic opioid use and an increase in the incidence of esophageal motor disorders has been demonstrated there are no prospective studies proving that discontinuation of opioid treatment results in the resolution of the esophageal motor disorder
Hypothesis During the performance of high-resolution esophageal manometries in our unit we have observed a higher prevalence of motor disorders in patients who consume opioids Our hypothesis based on the available literature is that most of these disorders can reverse upon discontinuation of opioid treatment without the need for more aggressive therapies To test this hypothesis a high-resolution manometry will be performed again after the patient has discontinued opioid treatment for at least 7 days
Outcomes
Primary Outcome Measure
Improvement in Esophageal Motility Description Evaluate the improvement in esophageal motility in chronic opioid users after discontinuation of opioids
Measurement Tool High-resolution esophageal manometry HREM Unit of Measure Manometric parameters eg integrated relaxation pressure IRP in mmHg
Secondary Outcome Measure
Improvement in Dysphagia Severity Description Assess the improvement in dysphagia severity in chronic opioid users after discontinuation of opioids
Measurement Tool Dysphagia Severity Score Unit of Measure Dysphagia score eg a numeric scale from 0 to 10
Description Evaluate in chronic opioid users with esophageal motor disorders the improvement in esophageal motility after discontinuation of opioids evaluated by high-resolution esophageal manometry
Secondary outcome
Determine if the symptoms that prompted the esophageal motility study disappear with the discontinuation of opioid treatment
Hypothesis During the performance of high-resolution esophageal manometries in our unit we have observed a higher prevalence of motor disorders in patients who consume opioids Our hypothesis based on the available literature is that most of these disorders can reverse upon discontinuation of opioid treatment without the need for more aggressive therapies To test this hypothesis a high-resolution manometry will be performed again after the patient has discontinued opioid treatment for at least 7 days
Outcomes
Primary Outcome Measure
Improvement in Esophageal Motility Description Evaluate the improvement in esophageal motility in chronic opioid users after discontinuation of opioids
Measurement Tool High-resolution esophageal manometry HREM Unit of Measure Manometric parameters eg integrated relaxation pressure IRP in mmHg
Secondary Outcome Measure
Improvement in Dysphagia Severity Description Assess the improvement in dysphagia severity in chronic opioid users after discontinuation of opioids
Measurement Tool Dysphagia Severity Score Unit of Measure Dysphagia score eg a numeric scale from 0 to 10
Description Evaluate in chronic opioid users with esophageal motor disorders the improvement in esophageal motility after discontinuation of opioids evaluated by high-resolution esophageal manometry
Secondary outcome
Determine if the symptoms that prompted the esophageal motility study disappear with the discontinuation of opioid treatment
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