Use of PillCam ESO2 in Triaging Patients Present With Upper GIB
Use of PillCam ESO2 in Triaging Patients Present With Upper GIB
Background

 -  Patients presented to hospital with coffee ground vomiting and black stool may not be
 actually having upper gastrointestinal bleeding (UGIB)

 -  Hospital admission can be avoided if serious UGIB can be excluded

 -  To date, the only useful tool to triage patient for hospital admission in UGIB is by
 using clinical score such as Rockall score or Blatchford score

 -  These scores are cumbersome and only exclude the most benign cases, but they are not
 useful in differentiating those who needs intervention

 -  In our pilot study, investigators found that capsule endoscopy can be used to identify
 patients with fresh blood and real coffee ground substance in the stomach and it is
 superior to nasogastric tube

 -  Most of UGI lesions leading to bleeding can be diagnosed by capsule endoscopy

 Objectives The current study is designed

 1. to validate capsule endoscopy is an effective method in identifying patients with UGIB

 2. to study whether the capsule endoscopy can reduce requirement of hospital admission in
 patients with suspected UGIB

 3. to study if capsule endoscopy can help to identify patients with UGIB that may require
 urgent (within 24 hours) endoscopy and intervention

 4. to study the cost-effectiveness of capsule endoscopy being used as a triaging tool in
 the management of UGIB

 5. to compare the effectiveness of capsule endoscopy against Blatchford score in
 identifying patients with UGIB that may require endoscopic intervention.
Hypothesis PillCam Esophagus is effective in identifying genuine UGIB and hence able to
 reduce hospital admission due to unsubstantiated UGIB cases

 Methodology

 -  Patients presented to the Accident & Emergency Department (A&ED) of the Prince of Wales
 Hospital Hong Kong with symptoms suggestive of UGIB will be recruited into this study

 -  Patients will receive the following tests

 -  Complete blood count

 -  Coagulation profile

 -  Renal and liver function tests

 -  Hourly BP, Pulse up to 6 hours

 -  Glasgow Blatchford score calculated on admission

 -  Randomization

 -  Capsule Group: Capsule Endoscopy (CE) by using PillCam Esophagus (PillCam ESO) OR

 -  Standard group: Hospitalization and Standard of Care

 -  The video in capsule endoscopy will be read by trained personnel who have undergone at
 least one hour lecture about realtime reviewing.

 -  Legally a patient has to be signed off by a clinician within 6 hours. The finding of
 fresh blood or coffee ground will be documented. Upper GI pathology that may lead to
 bleeding will also be recorded.

 Capsule Endoscopy (CE) After confirming patient has been fasted for at least 5 hours, the
 subject ingested the PillCam® ESO 2 (Given Imaging Ltd., Yoqneam, Israel) (PillCam ESO) using
 the Simplified Ingestion Procedure.

 Thirty to sixty minutes prior to capsule ingestion, each subject received a single dose of
 intravenous Maxolon 10mg. Intravenous Maxolon, through its motilin receptor agonist effect,
 has been shown to promote gastric motility and improve visualization of the gastric mucosa at
 endoscopy. Moreover, use of Maxolon was thought to facilitate the capsule entering the
 duodenum.

 Using the REAL time viewer, UGI tract images (esophagus to the second portion of the
 duodenum) were obtained in real time at the patient's bedside. The video images that are
 transmitted by the PillCam ESO 2 are displayed in real time on the tablet computer screen.

 Each subject is also fitted with and wore the standard CE sensor array and data recorder so
 that a full-length CE video recording can be obtained for subsequent capsule workstation
 downloading and complete review.

 Other demographic data and parameters for Blatchford score calculation will be collected. 10
 ml of blood will be taken for routine blood checking. Patients will receive standard care
 according to EGD findings.
Inclusion Criteria:

 Individual aged ≥ 18 years presenting to the emergency department with acute, overt UGIB
 defined as coffee ground vomiting and/or melena

 Exclusion Criteria:

 -  UGIB with hemodynamic shock (BP<90mmHg and pulse>120 per minutes) requiring urgent
 endoscopy,

 -  UGIB with fresh hematemesis requiring urgent endoscopy

 -  dysphagia, odynophagia, swallowing disorder, Zencker's diverticulum, suspected bowel
 obstruction or bowel perforation,

 -  prior bowel obstruction, gastroparesis or known gastric outlet obstruction, Crohn's
 disease, past GI tract surgery.

 -  presence of an electromedical device (pacemaker or internal cardiac defibrillator),

 -  altered mental status (e.g., hepatic encephalopathy) that would limit patient ability
 in swallowing the capsule, pregnancy and/or lactating, allergy to conscious sedation
 medications, allergy to Maxolon, unwillingness to swallow the capsule, patient
 expected to undergo Magnetic Resonance Imaging examination within 7 days of ingesting
 the capsule, patient on medications that may coat the upper GI tract such as antacids
 or sucralfate, or inability to provide written informed consent.

 -  Allergy to Maxolon

 -  Patients with known Esophageal Varices or Gastric Varices with or without prior
 bleeding episodes

 -  Known upper/ lower GI cancer (eg, cancer of esophagus, stomach, small bowel, colon) or
 hepatocellular carcinoma or pancreatic cancer