Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study

Launched by UNIVERSITY OF CALGARY · Aug 8, 2017

Keywords

ClinConnect Summary

As part of the standard clinical evaluation of our department, all patients presenting to the Calgary Gut Motility Centre with dysphagia routinely undergo a thorough clinical assessment including history taking and physical examination. Depending on their presentation, further evaluation may include upper endoscopy, barium swallow, esophageal manometry, and pH testing.

Patients meeting inclusion and exclusion criteria will receive prucalopride for 5 days total, with 2mg on day 1, then 4mg on days 2 to 5. On day 5 of the intervention, patients will undergo esophageal manometry. Patients wil...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Symptom of dysphagia
• • Esophageal findings consistent with ineffective esophageal motility (IEM), defined as per the Chicago Classification as ≥50% ineffective swallows. Ineffective swallows include both failed swallows, defined by an average distal contractile integral (DCI) \<100mmHg\*cm\*sec, and weak swallows, defined by an average DCI \>100 but \<450mmHg\*cm\*sec
• • Normal endoscopy
• • If female of childbearing potential, a negative urine pregnancy test administered 1 day prior to taking the study medication (prucalopride)
• • Able to provide informed consent
• Exclusion Criteria:
• • Clinical evidence (on history, physical exam, or investigations) of significant cardiovascular, respiratory, gastrointestinal, hepatic, hematological, renal, neurological, or psychiatric comorbidities that may interfere with the objectives of the study and/or pose safety concerns, including pregnancy and breastfeeding
• • History of cardiovascular disorder including myocardial infarction, life-threatening arrhythmias, pacemaker or defibrillator
• • Estimated GFR \<30, documented within 6 months preceding study entry
• • Blood electrolytes (Na, K, CL) measured within past 6 months outside of normal reference ranges
• • Uncontrolled gastroesophageal reflux disease on pH testing (DeMeester score \>14.7)
• • Established esophageal motility disorder, including but not limited to achalasia, spastic disorders, Esophagogastric junction (EGJ) outflow obstruction, and absent contractility
• • History of gastrointestinal surgery, including hiatal hernia repair and/or fundoplication, or any major surgery in the 3 months preceding study entry
• • Use of narcotics or prokinetic treatments that cannot be stopped prior to study entry
• • Use of laxatives that cannot be stopped prior to study entry
• • Use of tricyclic antidepressants at a dose of \>25 mg daily (stable doses of SSRIs/ SNRIs are permitted)
• • Use of macrolide antibiotics (non-macrolide antibiotics are permitted)
• • Participation in clinical trial with prokinetic treatment in the 30 days preceding study entry