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

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 Oesophageal Impactions

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001055493

Acronym

FOODS

Enrollment

Registered

2016-08-08

Start date

2018-03-01

Completion date

2021-07-01

Last updated

2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The project aims to determine if the two commonly used drug regimens for soft food impactions in the oesophagus are better than placebo for passage of the obstructing bolus. Retrospective data from small and poorly-designed studies have led to the recommendations for the trial of glucagon, glyceryl trinitrate (GTN) or a combination of both in soft food bolus impactions as first line management prior to endoscopy. Retrospective data from a recent audit carried out at Freemantle has demonstrated that the rate of clinical resolution was not appreciably different between patients treated with drugs and patients not treated with drugs and that a strategy of proceeding straight to endoscopy might be preferable In order to definitively answer the question, we propose to prospectively assign patients to either a drug regimen of a) glucagon and GTN or b) placebo and observe the outcomes after 30 minutes after which the pharmacological properties of the drugs excludes a drug effect.

Interventions

Glucagon 2mg intravenous + Glyceryl trinitrate 600mg orally administered simultaneously as a single administration No strategy to monitor adherence is necessary as drugs will be administered by trained nursing staff.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results