RecruitingACTRN12616000636459

Early Capsule Endoscopy in Acute Upper Gastrointestinal Bleeding.

A prospective randomised control trial of Early Capsule Endoscopy in patients with Acute Upper Gastrointestinal Bleeding.


Sponsor

QLD Health

Enrollment

60 participants

Start Date

May 1, 2017

Study Type

Interventional

Conditions

Summary

All patients with upper gastrointestinal bleeding (UGIB) undergo a gastroscopy urgently. However, in a significant proportion of these patients a source is not identified. Small bowel bleeding is highly likely to be the source in a large number of these patients. This may be identified by capsule endoscopy. Proximal colonic bleeding is also likely in patients with melaena and is identifiable by colonoscopy. As per current standard practice, patients will undergo a colonoscopy frequently or a capsule endoscopy (CE) less often, in an attempt to find the cause of bleeding. Capsule endoscopy is noninvasive, better tolerated and preferred by patients as bowel prep and anaesthesia are not required. However,it is uncertain who will benefit most by having a capsule endoscopy as the second test. The focus of our study is to look at the subgroup of patients who will benefit most by having early Capsule Endoscopy in this context. The study aims to compare two groups of patients, one having capsule endoscopy VS the other having colonoscopy as the second test following a negative gastroscopy to determine differences in ability to detect bleeding source and therefore change patient outcome. All patients with UGIB with a negative gastroscopy will be considered for the study. This is a prospective randomised control trial. Primary endpoint measured will be identification of the source of bleeding. Secondary endpoints measured will be reduced blood transfusions, reduced length of stay, reduced number of investigations and reduced hospital admissions.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is studying what happens when patients are admitted to hospital with upper gastrointestinal bleeding (vomiting blood or passing black, tarry stools) but a standard stomach camera test (gastroscopy) does not find the source of the bleeding. Researchers want to find out if a swallowable camera capsule (capsule endoscopy) is better than a colonoscopy at finding where the bleeding is coming from. The study aims to reduce unnecessary tests, blood transfusions, and hospital stays. You may be eligible if: - You are 18 years or older - You have been admitted to hospital with vomiting blood or passing black tarry stools - Your gastroscopy (stomach camera) did not find the source of the bleeding - You are male or female You may NOT be eligible if: - You are under 18 years of age - You are pregnant Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This research involves procedures and clinical care which are performed as standard practice currently. Patients with a negative gastroscopy will be randomised to either the control group and receive

This research involves procedures and clinical care which are performed as standard practice currently. Patients with a negative gastroscopy will be randomised to either the control group and receive a Colonoscopy, or the intervention group and receive a Capsule Endoscopy as their second investigation. Those patients randomised to the Capsule Endoscopy group will be orally administered a single disposable endoscopy capsule which will pass through the gastrointestinal tract taking continuous images that will be sent to a data receiver, This data will be downloaed and interpreted by a trained gastroenterologist. This will all be completed during athe same inpatient hospital admission.


Locations(1)

Gold Coast Hospital - Southport

QLD, Australia

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ACTRN12616000636459