CompletedNot Applicable

Navicam as a Triage Tool in the Management of Patients With Acute Upper Gastrointestinal Bleeding

China, Hong Kong100 participantsStarted 2020-04-21

Plain-language summary

Acute upper gastrointestinal bleeding(AUGIB) is a common emergency. The NaviCam (ANKON) is a miniaturised wireless endoscope in a single use capsule. It can be remotely controlled with the patient in a magnetic console.. In patients with AUGIB, NaviCam has been compared to conventional esophago-gastro-duodenoscopy (EGD) in their diagnostic yields. NaviCam has been shown to detect more lesions including those in the small bowel. There are therefore several theoretical advantages to the use of NaviCam in the management of patients with AUGIB.An initial NaviCam examination allows triaging of patients. Those with low risk lesions can be discharged without EGD and hospital admission. These represent substantial reduction in resource utilisation. In the diagnosis of small bowel lesions, the yield from a video capsule examination is higher closer to the time of index bleed. The primary objective of the study is to determine the diagnostic yield of NaviCam in patients who present with overt signs of AUGIB. In addition, the investigators aim to determine if NaviCam examinations can reduce hospital resource utilisation and compare the use of NaviCam as a triage tool to the use of risk scores such as the Glasgow Blatchford Score (GBS). The investigators hypothesize that early NaviCam examination can allow safe discharge of more patients when compared to GBS.

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 who present with overt signs of acute upper gastroinestinal bleeding (hematemesis or melena) and are hemodynamically stable (systolic blood pressure \> 100 mmHg and pulse less than 100 per minute). Exclusion Criteria: * patients who are below the age of 18 and above 80 years, * patients with permanent pacemakers and other metallic implants that preclude magnetic resonance examinations * patients who are difficult to swallow capsule (e.g pharyngeal dysfunction, poor conscious state * patients who are at risk of capsule retention (e.g. previous gastric surgery, inflammatory bowel disease) * patients who are unable to provide an informed consent * patients who are in pregnancy

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

diagnostic yield of capsule endoscopy

Timeframe: at the time of capsule endoscopy

Trial details

NCT IDNCT04197843

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-30

View on ClinicalTrials.gov More GastroIntestinal Bleeding trials