Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04197843 |
| Other study ID # |
NaviCam |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 21, 2020 |
| Est. completion date |
July 30, 2021 |
Study information
| Verified date |
May 2022 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
INTRODUCTION Background/ rationale Acute upper gastrointestinal bleeding (AUGIB) is a common
emergency. The incidence varies from 50 to 110 per 100,000 population. In the majority of
patients with AUGIB, bleeding is self-limiting and often has stopped spontaneously on
presentation. Traditionally patients undergo early endoscopy (within 24 hours) for the
purpose of finding the source of bleeding and if actively bleeding is seen from a lesion,
endoscopy hemostatic treatment is then applied.
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. The operator to the
magnetic-driven NaviCam sits in a computer workstation and manipulates the capsule suspended
in a waterfilled stomach. After careful examination of the stomach, the capsule is then
allowed to passed through the pylorus into duodenum and small bowel. The patient wears
harness with small bowel imaging capabilities. 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. First, the NaviCam procedure is well tolerated and in fact preferred by many
patients. It is convenient to administer. Second, NaviCam can in addition examine small
bowel. About 20% of patients with overt signs of AUGIB bleed from small bowel or colon. 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.
Objectives 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.
METHODS Study design The investigators plan to conduct a prospective cohort study at the
Prince of Wales Hospital, Shatin. The investigators enrol patients who present to the
Accident and Emergency Department with overt signs of AUGIB (hematemesis or melena) and are
hemodynamically stable (systolic blood pressure > 100 mmHg and pulse less than 100 per
minute). The investigators intend to keep a log of all patients who present with AUGIB and
are being referred for EGD. The investigators record their admission Glasgow Blatchford
Score. The investigators exclude patients who are below the age of 18 and above 80 years,
those with permanent pacemakers and other metallic implants that preclude magnetic resonance
examinations, those with pharyngeal dysfunction that render them difficult to swallow, those
with poor conscious state with the concern of aspiration and patients known to have risks of
capsule retention e.g. previous gastric surgery, inflammatory bowel disease, patients who are
unable to provide an informed consent and those in pregnancy.
Patients are required to fast for 6 hours. Before the examination, the patient ingests 400 mg
simethicone dissolved in 100 ml of water to distend the stomach. He then drinks an addition
of one liter of water 10 minutes before the examination. An activated NaviCam (ANKON) is then
swallowed with the patient in a supine position in the MR console. This allows examination of
the esophagus and the squamo-columnar junction. An operator then drives the magnetic robot
and actively controls the capsule.
The stomach is examined according to a standardized protocol. (Figure 3) When the capsule
reaches the stomach, the capsule is lifted away from the posterior wall, rotated, and
advanced to the fundus (A), long shots (B), and close-ups (C) of the cardiac regions, and
then the posterior wall (D), the lesser and greater curvature (E) and anterior wall (F) of
the gastric body, followed by the angulus (G) and antrum (H) and finally the pylorus (I).
Full examination of the stomach is possible with patients lying in different positions.
To enable transpyloric passage of the capsule, the capsule is oriented to obtain an en face
view of the pylorus. The capsule is directed towards the pylorus. With active peristalsis,
the capsule traverse across the pylorus. If this proves difficult, the patient is stood up
and asked to walk freely. The capsule then drops into the duodenum. The patient is instructed
to wear a jacket or harness with a data recorder. Real time examination of the duodenum is
possible. The small bowel examination is completed usually after the patient is discharged or
hospitalized.
The patient's comfort level is recorded over a 10 cm visual analogue scale at the end of the
examination.
Decision to clinical admissions The decision to discharge the patient is left to the
discretion of the on-duty GI specialist after review of the video sequences. Criteria to
discharge include, Forrest IIc and III gastroduodenal ulcers, GI erosions together with
minimal coffee materials or a clean stomach, admission hemoglobin of 8 g/dl and haematocrit >
0.24, good family support. Patients are discharged on appropriate medications e.g. a proton
pump inhibitor. Those discharged will be asked to return the data recorder the next day.
Patients are then reviewed by a GI specialist. Patients are also instructed to contact the on
duty GI specialist at the Prince of Wales Hospital should they have any query. In general, a
patient with a capsule examination that shows fresh blood in the GI tract, lesions with major
stigmata of bleeding, evidence of esophago-gastric or upper GI varices are admitted for
further management. Patients on anticoagulation therapy require to be admitted for titration
of these drugs. Patients with significant comorbid illnesses that would require in hospital
stabilisation.
Variables The investigators obtain patients' demographic data, medical history including
concurrent illnesses and current and past drug use, biochemical and hemodynamic data.
The investigators adopt a standardised pathology reporting scheme to minimize interobserver
reporting variability. Focal lesions were defined as peptic lesions (esophageal, gastric and
duodenal erosions, and ulcers), vascular lesions (angioectasia, esophageal varices of all
grades, gastric, and duodenal varices) and fresh/altered blood (without an obvious source).
Significant lesions were those considered to be the cause of bleeding and included peptic
ulcers (esophageal, gastric, and duodenal), esophageal varices of at least grade 2, and
gastric varices. In fact, the computer station has an Artificial intelligence function that
enables real time diagnosis of observed lesions and in addition the thoroughness and
percentage of stomach examined.
All patients are followed up till day 30 after inclusion into the current study.
The investigators intend to enrol 100 consecutive patients. No formal sample size is
calculated as this is considered a pilot study.
