An Observer Blinded Comparison of MACE and Conventional Upper Gastrointestinal Endoscopy in Upper… (NCT02690376) | Clinical Trial Compass
CompletedNot Applicable
An Observer Blinded Comparison of MACE and Conventional Upper Gastrointestinal Endoscopy in Upper GI Bleeding
United Kingdom23 participantsStarted 2016-03
Plain-language summary
Gastroscopy (OGD) is a useful test for investigating a variety of suspected upper GI disorders. But it is uncomfortable for patients and incurs the risk of intubation and sedation, plus a large proportion of procedures reveal insignificant or no pathology. Capsule endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe, non-invasive and well-tolerated. The use of CE is traditionally restricted to the small bowel, although newer capsules to image the oesophagus and colon are currently in use. Previous capsules have failed to adequately image the stomach due to its' large volume and rugal folds. Recently a magnetic capsule and handheld magnet has been developed (Mirocam Navi, Intromedic Ltd, Seoul, Korea) to enable an element of manoeuvrability of the capsule. This is unnecessary in the small bowel where the capsule is propelled along its' tubular structure by peristalsis, but in the capacious stomach this may allow the capsule to be steered to examine all areas of the stomach. We have already conducted two feasibility studies in porcine models with promising results and a trial has already evaluated the equipment to steer the small bowel capsule through the stomach into the duodenum. An ongoing study is comparing the ability of this technique to examine the stomach against conventional OGD, in patients with recurrent iron deficiency anaemia. The next stop would be to compare the two modalities under other different conditions.
We wish to undertake a prospective single blind controlled trial comparing magnetically assisted capsule examination to conventional OGD in diagnosing upper gastrointestinal pathology in patients with gastrointestinal bleeding.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 years and over
* Patients presenting with haematemesis (fresh blood or coffee grounds) and/or malaena within the previous 48 hours, who require a gastroscopy as part of their diagnostic investigations
Exclusion Criteria:
* Patients under the age of 18 years or over the age of 80 years.
* Patients who have a suspected UGIB and haemodynamic instability, i.e. hypotension (systolic blood pressure \<100mmHg) and tachycardia (\>100 bpm), requiring urgent resuscitation
* Pre-endoscopy Rockall score \>4 (patients with a lower pre-endoscopy Rockall score but haemodynamically unstable will still be excluded)
* Active vomiting or haematemesis
* Patients with a permanent pacemaker, implantable cardioverter-defibrillator or REVEAL device
* Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators
* Patients with dysphagia, odynophagia or known swallowing disorder
* Patients with known Zenker's diverticulum
* Patients with suspected bowel obstruction or bowel perforation
* Patients with prior bowel obstruction
* Patients with gastroparesis or known gastric outlet obstruction
* Patients with known Crohn's disease
* Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure)
* Patients that are pregnant or lactating
* Patients with altered mental status that would limit their ability to swallow
* Patients with allergy to consci…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic yield of pathology of MACE compared to gastroscopy.
Timeframe: Baseline - one visit only
Trial details
NCT IDNCT02690376
SponsorSheffield Teaching Hospitals NHS Foundation Trust