Minimally Invasive Evaluation of Dyspepsia by Combined Magnetically Controlled Capsule Endoscopy and Urea Breath Test: a Pilot Prospective Cohort Study
Condition: Dyspepsia; Peptic Ulcer Disease; Gastroesophageal Reflux; Ugi Malignancies; Pancreatobiliary Disease
MeSH terms: Gastroesophageal Reflux; Peptic Ulcer; Dyspepsia
Study type: Interventional

Summary: 
      The combined diagnostic accuracy of MCCE and UBT in Hong Kong patients with uninvestigated
      dyspepsia between age 35 to 60 years for structural pathology and HP infection is comparable
      to that of conventional UGI endoscopy with histological examination for HP
    

Detailed description: 
      Dyspepsia affects about 20% of the population globally and represents one of the commonest
      reasons for patients to seek medical consultation.1-3 The definition of dyspepsia has evolved
      over time and generally encompasses a variety of upper gastrointestinal (UGI) symptoms that
      can be of anatomical or functional origin such as epigastric pain or burning, bloating,
      postprandial fullness, belching, early satiety and nausea.2, 4 While diagnostic criteria (eg,
      Rome IV criteria) have been proposed to better characterize and standardize symptoms of
      functional dyspepsia for research purpose, there is considerable overlap of clinical
      presentation between functional dyspepsia and organic / anatomical causes of dyspeptic
      symptoms such as peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD), UGI
      malignancies, or pancreatobiliary diseases.2, 3, 5, 6 Therefore, it is of clinical importance
      to differentiate clinically significant anatomical pathologies from functional disorders
      during the initial evaluation of patients with dyspeptic symptoms.

      Society guidelines based on Western population data with a relatively lower prevalence of
      helicobacter pylori (HP) and UGI cancers (eg, cancer of stomach, esophagus) generally
      recommend an initial noninvasive management approach (eg, "test and treat" strategy for HP
      and empiric trial of acid suppressive therapy) in dyspeptic patients without alarming
      symptoms or age < 50 - 60, and reserve upfront endoscopy for high-risk patients with alarming
      symptoms (eg, gastrointestinal bleeding, iron deficiency anemia, dysphagia, unintended weight
      loss, etc) or age ≥ 50 - 60.2, 3 However, in Asian populations with a relatively higher
      prevalence of HP and UGI cancers, an initial noninvasive management approach to dyspeptic
      symptoms based on alarming symptoms and age cutoff at 50 - 60 years may not be entirely
      appropriate since up to 25% of patients with UGI cancers may not have alarming symptoms.7 In
      a recent systematic review with meta-analysis of dyspepsia management in Asian countries,
      alarming symptoms and age were found to be poor predictors of UGI cancers and 17.8% of
      dyspeptic patients who were eventually diagnosed with UGI cancers were younger than age 45.6

      In a study of 5066 UGI endoscopies performed in Asian patients with dyspepsia, clinically
      significant structural pathologies (PUD, cancers of stomach / esophagus, esophagitis) were
      found in 19.5% of patients.8 Although UGI endoscopy is the gold standard for diagnosis of
      clinically significant structural pathologies and HP infection by histology, it is an
      invasive procedure with a small but finite risk of complication.3 When compared to the
      invasive nature of conventional UGI endoscopy, an initial minimally invasive diagnostic
      approach that can evaluate for both UGI structural pathology and HP infection would be highly
      desirable and clinically relevant in Asian patients with uninvestigated dyspepsia between 35
      to 60 years of age.

      Wireless capsule endoscopy (CE) (commonly known to the general public as the "pill camera")
      represents a minimally invasive diagnostic modality for visualization of the gastrointestinal
      (GI) tract and is well tolerated by patients.9 While conventional CE has been shown to
      provide adequate visualization of luminal pathologies in the small bowel, colon and
      esophagus, visualization of the different parts of stomach by conventional CE remains
      challenging due to its passive propulsion through the GI tract by peristalsis or gravity and
      the large cavity size of the stomach. Recently, magnetically controlled capsule endoscopy
      (MCCE) systems comprised of small capsule endoscope, guidance magnet robot, data recorder,
      and computer workstation for real-time viewing and control of CE have become available and
      can provide a more controlled visualization of different anatomical parts of the stomach by
      CE.10, 11 In a study of 350 patients with UGI symptoms requiring conventional UGI endoscopy
      for evaluation, MCCE was shown to be safe and was able to provide adequate visualization of
      the stomach with a high sensitivity (90.4%) and specificity (94.7%) for focal gastric lesions
      when compared with conventional UGI endoscopy.11 However, despite its promising role as a
      minimally invasive diagnostic modality for structural pathologies of stomach, MCCE does not
      allow tissue acquisition and thus cannot provide information on HP infection status by rapid
      urease test (RUT) or histological examination. On the other hand, noninvasive test for HP by
      urea breath test (UBT) has been shown to be highly sensitive and specific for HP infection
      and can supplement MCCE to provide important information on the status of HP infection.12

      To date, there has been no dedicated study on the use of combined MCCE and UBT for minimally
      invasive evaluation of dyspepsia in Asian population. In order to address the gap in
      knowledge, we would like to propose a pilot prospective cohort study to investigate the
      clinical utility of combined MCCE and UBT as the initial minimally invasive evaluation of
      uninvestigated dyspepsia in Hong Kong patients between 35 to 60 years of age.
    

Intervention name(s): MCCE
Intervention type(s): Procedure
Intervention description(s): Mangetically controlled capsule endoscopy will be performed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic