The Food Obstruction in Oesophagus and Drugs Study: A Double Blinded Randomised Control Trial of Glucagon and Glyceryl Trinitrate Versus Placebo In Soft Food Bolus Impactions
Phase 3
- Conditions
- Soft food bolus impactionOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12616001055493
- Lead Sponsor
- Fiona Stanley Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
a.Patients with first presentation of soft food bolus impaction
b.Patients above or equal to 18 years old
c.Patients capable of furnishing informed consent
Exclusion Criteria
a.Known oesophageal malignancy or structural abnormalities
b.Previous presentation with soft food bolus oesophageal impaction
c.Known allergy or intolerance to glucagon or GTN
d.Extrinsic or intrinsic airway compromise
e.Oesophageal impaction with inedible or hard foods (e.g. bones, pills, nails)
f.Preload dependent cardiovascular physiology (e.g. severe aortic stenosis, hypotension)
g.Known insulinoma, pheochromocytoma or glucagonoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical resolution of impaction by 30 minutes post administration of drugs as defined by:<br>a.Ability to tolerate food and fluids without regurgitation<br>b.No regurgitation of secretions<br>c.Clinical gestalt of senior ED doctor<br>[30 minutes from administration of drug]
- Secondary Outcome Measures
Name Time Method Endoscopy rate which will be calculated by checking each participant's medical record for endoscopy records [48 hours post first presentation to the ED];Evidence of oesophageal pathology whether by direct visualisation on endoscopy or subsequent histopathological examination of biopsy specimens [3 months post first presentation to the ED]