Navicam as a Triage Tool in the Management of Patients With Acute Upper Gastrointestinal Bleeding
Condition: GastroIntestinal Bleeding
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): NaviCam (ANKON)
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic