Video Capsule Endoscopy (VCE) Comparison Study
Condition: Bleeding; Anemia; Diarrhea
MeSH terms: Hemorrhage; Diarrhea
Study type: Interventional

Summary: 
      MiroCam® is the new video capsule endoscope of IntroMedic®. By using a novel transmission
      technology it promises a longer battery life expectancy with consequential impact on the
      length of the video recorded for diagnostic evaluation. As the investigators know about the
      shortcoming of battery life expectancy from many capsule examinations that were inconclusive
      because the ileocaecal transit was not filmed, the investigators would appreciate to have a
      capsule with extended video recording to improve the diagnostic yield of capsule
      examinations. Therefore the investigators want to compare MiroCam® to our routinely used
      Olympus® Enteropro EndoCapsule® in the context of a half-year clinical trial. Focussing on
      the total video length as well as on the rate of video-recorded ileocaecal transitions as
      surrogate parameters the investigators want to find out whether one of the two products
      provides superior diagnostic information in order to reduce the amount of inconclusive
      examinations.
    

Detailed description: 
      Introduction

      Video capsule endoscopy (VCE) is an important tool in the diagnostic management of several
      gastrointestinal (GI) disorders. Taking a video while passing the GI tract, VCE is the only
      technique providing image information of the whole small bowel. It is a comfortable and safe
      procedure; complications due to capsule retention are rare [1]. The main disadvantage of VCE
      is made up by its only dependence on macroscopic information. Therefore it can not be
      reliably used for the detection of disorders that need histological confirmation. However,
      lots of macroscopic pathologies can be diagnosed or excluded by VCE. Above all, obscure
      digestive bleeding (ODB) has become the main indication for the use of VCE [2].

      Independent from the type of bowel preparation used, the ileocaecal transit cannot be
      visualized in up to 20 percent of VCE examinations, which means the loss of diagnostic
      information of the last intestinal parts [3]. Risk factors of such incomplete VCE include
      previous small-bowel surgery, hospitalization, moderate or poor bowel cleansing and a gastric
      transit time longer than 45 minutes [4]. Especially in the latter case, the success of the
      examination is determined by the battery life expectancy of the capsule technology used [5].

      The new MiroCam®, a brand of IntroMedic®, is advertised to have a longer battery life
      expectancy than competitive products throughout the market. To prove this pronouncement, a
      pilot-study of 16 patients was presented by He Man Kim at the UEGW 2008, comparing MiroCam®
      to Given®'s PillCam® by sequential application of both capsules. Although the battery life
      expectancy of MiroCam® was significantly higher, there was no significant difference in the
      diagnostic yield of both products [6]. Currently a similar comparison study between MiroCam®
      and Pill Cam® is ongoing in France, involving a higher amount of patients [unpublished data].

      Study Aims

      In this prospective study we want to compare IntroMedic®'s MiroCam® to Olympus® Enteropro
      EndoCapsule® which was so far routinely used at our department. We want to investigate
      whether one of the two products provides superior diagnostic information about the small
      bowel. The primary endpoint will be the total video length registered as well as the rate of
      successful ileocoecal transitions during ongoing video registration. The secondary end point
      will be the number of pathologies detected by each capsule. If there will be a significant
      difference between the two tested products, preferred usage of the superior product may
      improve the diagnostic yield of future examinations by avoiding incomplete video registration
      of the small bowel.

      Study Design

      Prospective Study without randomisation or blinding

      Study Population

      Patients transferred to our unit to undergo video capsule endoscopy because of

        -  Obscure digestive bleeding (ODB)

        -  Chronic anaemia of unknown origin

        -  Chronic diarrhoea

      Exclusion criteria:

        -  Patients age below 18 years

        -  Patients presenting with contraindications to video capsule endoscopy which are already
           known gastrointestinal stenoses, already known gastrointestinal adhesions, already known
           diverticula of the small bowel, already known severe or diabetes induced intestinal
           hypomotility

        -  Refusal to participate in the study

      Methods

      Our investigation will be performed at the Medical University of Vienna, department of
      medicine III, clinical division of gastroenterology and hepatology. Patient recruitment will
      start on the 1st of January 2010. The study will last for six month. The number of patients
      included within this period will be around 50, based on the current amount of VCE
      examinations performed at our department.

      All patients who fulfil the listed inclusion criteria, will receive the patient information
      form of this study together with the routine informed consent form of VCE. Potentially
      occurring questions about the course of the examination, data acquisition and processing in
      context of the study will be answered by medical professionals.

      As routine preparation for VCE, patients will receive 2 litres of washout solution on the
      previous day of their examination. At the day of the procedure fasting is required. The
      patient will swallow the first capsule after successful mounting of adhesive electrodes and
      registering tool of both capsule products. The second capsule will be swallowed two hours
      later - to our knowledge the first capsule will have already passed the gastro-duodenal
      transit at this time. The two capsules used in our investigation are the already mentioned
      MiroCam® (product of IntroMedic®, Seoul, Korea) and the Enteropro EndoCapsule® (product of
      Olympus®, Tokyo, Japan). To reduce bias made up by the sequence of the capsules used, we will
      randomize the capsule positions at each examination, following a computer generated list.
      After both capsules have been swallowed, fasting has to be continued for four hours to
      prevent image interference of VCE.

      Risk/Benefit Assessment

      The safety of both products used within our investigation was already proved in former
      clinical trials [7, 8]. For the patients enrolled in our study the potentially higher risk of
      complications will be made up for the expected increase of diagnostic yield that will be
      implicated by the evaluation of two different bowel videos. The only notable discomfort for
      patients participating in our investigation will be caused by the rather high amount of
      adhesive electrodes necessary for both capsules. There should not be any interference of the
      two video signals as already shown in former investigations [6,9].
    

Intervention name(s): Video capsule endoscopy (VCE); MiroCam; Enteropro EndoCapsule
Intervention type(s): Procedure; Device; Device
Intervention description(s): In the context of video capsule endoscopy the patient will swallow the first capsule after successful mounting of adhesive electrodes and registering tool of both capsule products. The second capsule will be swallowed two hours later. The two capsules used in our investigation are the MiroCam® (product of IntroMedic®, Seoul, Korea) and the Enteropro EndoCapsule® (product of Olympus®, Tokyo, Japan). To reduce bias made up by the sequence of the capsules used, we will randomize the capsule positions at each examination, following a computer generated list.; In the context of video capsule endoscopy the patient will swallow the first capsule after successful mounting of adhesive electrodes and registering tool of both capsule products. The second capsule will be swallowed two hours later. The two capsules used in our investigation are the MiroCam® (product of IntroMedic®, Seoul, Korea) and the Enteropro EndoCapsule® (product of Olympus®, Tokyo, Japan). To reduce bias made up by the sequence of the capsules used, we will randomize the capsule positions at each examination, following a computer generated list.; In the context of video capsule endoscopy the patient will swallow the first capsule after successful mounting of adhesive electrodes and registering tool of both capsule products. The second capsule will be swallowed two hours later. The two capsules used in our investigation are the MiroCam® (product of IntroMedic®, Seoul, Korea) and the Enteropro EndoCapsule® (product of Olympus®, Tokyo, Japan). To reduce bias made up by the sequence of the capsules used, we will randomize the capsule positions at each examination, following a computer generated list.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Obscure digestive bleeding (ODB); Chronic anaemia of unknown origin; Chronic diarrhoea