View From the Pill: Colon Capsule Endoscopy Guidelines For EU

In short

Israeli company Given Imaging, a pioneer of capsule endoscopy, has announced the publication of guidelines that provide physicians with a framework for using capsule endoscopy, including devices such as its own PillCam COLON 2 in daily clinical practice.

Background

Commissioned by the European Society of Gastrointestinal Endoscopy (ESGE), the guidelines are the first to standardize the clinical indications, reporting and work-up for colon capsule endoscopy procedures. They will join a list of procedural guidelines usefully available on the organisation’s website. Furthermore they will be published in the May edition of Endoscopy, the official journal of the ESGE.

According to the Given Imaging press release, the full version of which can be found here, the colon capsule endoscopy guidelines address three key areas of clinical practice.

  • First, the guidelines describe in detail the indications and contraindications for colon capsule endoscopy.
  • Second, the guidelines establish standards for bowel preparation, including diet regimen, the use of boosters, administering prokinetics and patient education about bowel preparation.
  • The guidelines also provide protocols for the report and work-up of colon capsule endoscopy results.

Consensus findings include:

Utilization

Colon capsule endoscopy is a safe, reliable and feasible method for visualization of the colon mucosa in average risk patients, patients who had previously had an incomplete colonoscopy, and patients unwilling or unable to undergo colonoscopy.

Reporting and Follow Up

Patients with significant findings should be referred to colonoscopy for polypectomy and patients without significant findings should repeat the colon capsule endoscopy procedure or a different screening test every five years.

The report also states that additional studies are needed to support the level of evidence and grade of recommendation in general and, especially, in the indication of screening using the second generation of colon capsule.

The guidelines will be considered for review in 2014 or sooner if new evidence becomes available.

Clinician comments about Pillcam COLON 2

“PillCam COLON 2 gives physicians the option to use a non-invasive and accurate diagnostic exam for direct visualization of the colon. Since PillCam COLON became commercially available in Europe and other parts of the world in 2009, utilization of this technology to visualize colon mucosa in patients contraindicated for colonoscopy or unwilling to undergo the procedure has increased, as has the number of clinical publications validating its utility,” said Cristiano Spada MD, Catholic University, Rome, Italy and a paid consultant to Given Imaging. “In creating these evidence-based guidelines, our goal was to provide healthcare providers with a standardized protocol to ensure proper patient selection, administration and use of this novel technology in daily practice.”

Company comments

“Many patients who should be screened are non-compliant due to a variety of reasons and we believe PillCam COLON 2 offers an important new option, providing the optimal balance of low risk, convenience and high diagnostic accuracy,” said Homi Shamir, president and CEO, Given Imaging. “We are very pleased with the publication of ESGE colon capsule endoscopy guidelines which will support our efforts to educate physicians regarding the clinical utility and benefit of using PillCam COLON for certain patients for whom colonoscopy might be risky including: patients taking blood thinning medications, patients with a higher risk of cardiopulmonary events during or after sedation, or those at risk of perforation. We continue to see the role of PillCam COLON expand and these guidelines will help support the broader launch of this product in Europe this year,” he added.

Notes:

Given Imaging supports an ESGE research grant to support innovative, original research in gastroenterology with substantial involvement of capsule endoscopy.

PillCam COLON 2, having been approved by the European regulators is CE marked, but was reportedly rejected by the FDA in the United States in 2008. Given Imaging is currently midway through an extensive clinical study into the use of Pillcam COLON2, as announced in a January press release which can be found here. The study is expected to extend to 800 patients and will support a further FDA submission.

Source: Given Imaging Press Release, Medgadget