PillCam Colon Capsule and CT-colonography in the Evaluation of Patients With Incomplete Conventional Colonoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Colorectal cancer (CRC) is the second most common cause of cancer-related death in the
      Western world, with 500000 deaths per year worldwide. Colonoscopy is accepted as a primary
      CRC screening tool in many countries. As a preventative procedure, its main purpose is to
      enable the early diagnosis of CRC at a curable stage and to identify and remove pre-malignant
      adenomas. Cecal intubation is associated with an increased detection rate of advanced
      neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. Complete colonic
      evaluation is therefore a well-recognized measure of colonoscopy quality control. Cecal
      intubation rates of ≥ 90% of all colonoscopies in routine clinical practice and ≥ 95% in
      screening colonoscopies are recommended. Unfortunately, the cecal intubation rate in daily
      clinical practice is often lower than the target of ≥ 90%, with reported percentages varying
      from 76.9% to 98.4%. This means that after an incomplete colonoscopy, malignant and
      pre-malignant lesions may be missed if further investigation is not pursued. Several
      explanatory factors for incomplete colonoscopy have been described. After an incomplete
      conventional colonoscopy, patients are required to undergo another test to complete the
      visualization of the colon. Options for incomplete examinations because of anatomic reasons
      include both radiologic and endoscopic means.

      CT Colonography (CTC ) permits to visualise the whole colon, is minimally invasive, does not
      require sedation and is well accepted by the patient.

      The PillCam Colon Capsule Endoscopy (Given® Diagnostic System)offers an alternative approach
      for endoscopic visualization of the colon in patients with an incomplete conventional
      colonoscopy. Advantages of the PillCam Colon Capsule Endoscopy (PCCE) include the elimination
      of the need for sedation, the minimally invasive, painless nature of the exam, no need of
      X-rays and the ability to pursue normal daily activities immediately following the procedure.
      This is a study that is designed to evaluate the performance of the PCCE in the evaluation of
      patients with an incomplete colonoscopy, compared to the CT-colonography. PCCE and
      CT-colonography procedures will be compared in regards to completeness of the procedure and
      detection of lesions in the colon that would have been missed by the incomplete conventional
      colonoscopy.
    

Detailed description: 
      Colorectal cancer (CRC) is the second most common cause of cancer-related death in the
      Western world, with 500000 deaths per year worldwide. Colonoscopy is accepted as a primary
      CRC screening tool in many countries. As a preventative procedure, its main purpose is to
      enable the early diagnosis of CRC at a curable stage and to identify and remove pre-malignant
      adenomas. Cecal intubation is associated with an increased detection rate of advanced
      neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. Complete colonic
      evaluation is therefore a well-recognized measure of colonoscopy quality control. Cecal
      intubation rates of ≥ 90% of all colonoscopies in routine clinical practice and ≥ 95% in
      screening colonoscopies are recommended. Unfortunately, the cecal intubation rate in daily
      clinical practice is often lower than the target of ≥ 90%, with reported percentages varying
      from 76.9% to 98.4%. This means that after an incomplete colonoscopy, malignant and
      pre-malignant lesions may be missed if further investigation is not pursued. Several
      explanatory factors for incomplete colonoscopy have been described. Patient factors that have
      been shown to increase the risk of an incomplete examination include advanced age, female
      sex, previous abdominal/pelvic surgery, and diverticular disease. After an incomplete
      conventional colonoscopy, patients are required to undergo another test to complete the
      visualization of the colon. Options for incomplete examinations because of anatomic reasons
      include both radiologic and endoscopic means.

      CT Colonography (CTC ) permits to visualise the whole colon, is minimally invasive, does not
      require sedation and is well accepted by the patient.

      The present role of CTC is the integration as a replacement for barium enema in the case of
      incomplete colonoscopy. In fact ,since 2006 the American Gastroenterological Association
      (AGA) Clinical Practice and Economics Committee has endorsed CTC as the method of choice for
      colon investigation in cases of incomplete colonoscopy and numerous evidence exists in the
      literature showing a clear superiority of CTC over Barium Enema in the detection of CRC and
      polyps.

      Two large, multicenter trials [the American College of Radiology Imaging Network (ACRIN)
      trial performed in the USA and Italian Multicenter Polyps Accuracy CTC study (IMPACT)trial
      testing the performance of CTC in comparison with conventional colonoscopy reported that a
      negative predictive values in both trials for CTC approaching 100%; this is extremely
      important in order to reassure negative patients about the significance of the
      examination.The PillCam Colon Capsule Endoscopy (Given® Diagnostic System)offers an
      alternative approach for endoscopic visualization of the colon in patients with an incomplete
      conventional colonoscopy. Advantages of the PillCam Colon Capsule Endoscopy (PCCE) include
      the elimination of the need for sedation, the minimally invasive, painless nature of the
      exam, no need of X-rays and the ability to pursue normal daily activities immediately
      following the procedure. Furthermore, PCCE may be well accepted by the subjects, thereby
      improving subjects' willingness to undergo a second diagnostic evaluation of the colon after
      the failure of the first endoscopic examination and comply with colorectal cancer screening
      recommendations. This is a study that is designed to evaluate the performance of the PCCE in
      the evaluation of patients with an incomplete colonoscopy, compared to the CT-colonography.
      PCCE and CT-colonography procedures will be compared in regards to completeness of the
      procedure and detection of lesions in the colon that would have been missed by the incomplete
      conventional colonoscopy.
    

Intervention name(s): PillCam Colon Capsule Endoscopy (Given® Diagnostic System)
Intervention type(s): Device
Intervention description(s): 2nd-generation CCE is 11.6x31.5 mm size, slightly bigger than previous capsule. It has 2 images with an angle of view increased to 172° degrees for each image. CCE-2 captures 35 images/sec. when in motion and 4 images/sec. when virtually stationary. Capsule battery life is at least 10 hours. The Recorder is an external receiving/recording and transmitting unit that receives data transmitted by the capsule. The portable Recorder consists of an antenna array which attaches to the body, a receiver and memory for accumulation of data during the exam. Data transmission is done via high capacity digital link. Workstation is a modified standard personal computer for reviewing videos generated from images acquired by the capsule, interpretation, analysis of acquired data and generating reports.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: colon capsule endoscopy; CT-colonography; Patients; incomplete colonoscopy