Patients with complaints of dysphagia and poor esophageal motility
Conditions
Sponsors
KU Leuven - TARGID
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A minimum of 18 years old; 2. Ineffective Esophageal Motility (IEM), fragmented peristalsis or absent contractility, as determined on HRM in the last three months before inclusion in the study, using the Chicago classification v3.0 (1). IEM is defined as =50% of 5ml liquid swallows being weak or failed (DCI 5 cm length) in the 20-mmHg isobaric contour with DCI >450 mmHg·s·cm) and not ineffective, with a normal IRP4. Absent contractility is defined a 100% failed swallows (DCI =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed during PPI treatment in the 12 months prior to screening, or = grade B when endoscopy is performed off PPI treatment. 2. Systemic diseases, known to affect esophageal motility (i.e. systemic sclerosis). 3. Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed). 4. QT c>450 ms. 5. Myasthenia Gravis or Eaton Lambert Syndrome. 6. Use of medication which effect cholinergic function such as anticholinergics, tricyclic antidepressants, calcium channel blockers. 7. Concomitant promotility agents such as: prucalopride or domperidone. 8. Aminoglycoside antibiotics. 9. Corticosteroids. 10. A cardiac disorder effecting electrical conductivity of the heart OR uninvestigated chest pain OR uninvestigated shortness of breath OR uninvestigated syncope. 11. An ECG finding or a new conductive abnormality which has not been previously identified (i.e. heart block, LBBB). 12. Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator. 13. Major psychiatric disorder. 14. Pregnancy or breast-feeding. 15. History of poor compliance. 16. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. 17. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the symptomatic and manometric factors associated with the use of neostigmine in patients with complaints of dysphagia due to poor esophageal motility;Secondary Objective: •To investigate the effect of neostigmine on other esophageal contractility parameters (distal latency, integrated relaxation pressure in 4s, EGJ pressures, number and size of defect in the 30 mm Hg isobaric contour) as measured by HRiM •To investigate the effect of neostigmine on symptoms during HRiM •To investigate several pressure flow parameters (integrated manometry and impedance) after administration of neostigmine: pressure flow index, impedance ratio, distal ramp pressure, intra-bolus pressure, pressure at nadir impedance, time from nadir impedance to peak pressure, distension pressure compartmentalized transport, distension pressure emptying, distension pressure accommodation, contractile segment impedance ;Primary end point(s): Mean change of distal contractile integral (DCI, mm Hg*s*cm) between pre- and post-neostigmine for the liquid boluses of 5 ml.;Timepoint(s) of evaluation of this end point: DCI is measured at baseline (which is a standard of care HRM) and after a one time application of neostigmine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Bolus passage score A Likert score applied during all swallows: 1-Normal, 2-Slow passage of bolus, 3-Stepwise passage, 4-Partial Blockage, 5-Complete Blockage. a) Mean score for each type of swallow b) Percentage of swallows with a score =4, averaged for each type of swallow. High-resolution manometry a) Distal latency (s) b) Integrated relaxation pressure in 4 seconds (mm Hg) c) EGJ basal tone (mm Hg) d) EGJ residual pressure (mm Hg) e) Length of defect in the 30 mm Hg isobaric contour of the distal esophageal segment above proximal LES border (cm) Pressure Flow Analysis a) Pressure Flow Index (PFI) b) Impedance Ratio (IR) c) Distal ramp pressure (RP, mmHg/s) d) Intra-bolus pressure (IBP, mmHg) e) Pressure at nadir impedance (PNI, mmHg) f) Time from nadir impedance to peak pressure (TNIPP, s) g) Contractile segment impedance (CSI, Ohms) h) Distension pressure emptying (DPE, mmHg) i) Distension pressure compartmentalized transport (DPCT, mmHg) j) Distension pressure accommodation (DPA, mmHg) ;Timepoint(s) of evaluation of this end point: All parameters are measured at baseline (which is a standard of care HRM) and after a one time application of neostigmine. | — |
Countries
Belgium
Contacts
Public ContactAns Pauwels
KU Leuven - TARGID
Outcome results
None listed