Upper Gastrointestinal Capsule Endoscopy as a Tool for the Triage of Haematemasis and Melaena

An open labelled, single arm and single blinded study of the diagnostic utility of capsule endoscopy over standard endoscopy for the diagnosis of upper gastrointestinal haemorrhage.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000867291

Enrollment

100

Registered

2009-10-06

Start date

2009-10-01

Completion date

2011-10-01

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Capsule endoscopy has the potential to be used as a fast and minimally invasive tool for the triage of patients presenting to hospital with bleeding from the upper gastrointestinal tract. This study aims to determine the utility of capsule endoscopy in this setting by comparing its success in finding a diagnosis for the bleeding when compared to findings made at gastroscopy.

Interventions

Study participants will swallow a capsule endoscope specifically designed to view the oesophagus and upper gastrointestinal tract. Images are transmitted wirelessly to a data recorder worn by the patient. The procedure is expected to take 2 hours. The capsule passes naturally through the bowel and is usually excreted in a bowel motion after 24 to 48 hours. All patients will have a gastroscopy which is current standard treatment. Gastroscopy takes 15 minutes to perform. This will occur at least

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All male and female patients 18 years or older admitted to the Alfred Hospital with symptoms and signs of upper gastrointestinal haemorrhage AND the patient requires an urgent gastroscopy (within 24hrs) for standard of care.

Exclusion criteria

Any significant condition that would make capsule endoscopy inappropriate including unstable medical conditions, the need for urgent surgery or immediate gastroscopy; Known or suspected obstructions or strictures in the gastrointestinal tract, including Crohn’s disease, significant prior abdominal surgery (excluding appendicectomy or cholecystectomy) or abdominal/ pelvic radiotherapy; Clinically significant dysphagia or a swallowing disorder; Excessive non-steroidal anti-inflammatory drug use; Known or suspected pregnancy or breast feeding; Inability to follow instructions; The need for magnetic resonance imaging within a week of capsule ingestion; The patient cannot give informed consent.

Outcome results