PillCam Starting To Look Like A Diagnostic Option Say Studies

It’s Digestive Disease Week(DDW) in Orlando’s Orange County Convention Center. At the event, PillCam capsule endoscopy pioneer Given Imaging Ltd, has announced data from several European studies. Data confirms the effectiveness of PillCam COLON in detecting colonic lesions in patients following incomplete colonoscopies and monitoring diverse digestive diseases in both adults and children.

Background

We’ve covered Pillcam before on our pages, most recently back in January when Given Imaging was considering whether to sell up. The company’s PillCam COLON video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source. It measures 11 mm X 31 mm and is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.

Equivalent to CT-Colonography, picks up more polyps

At DDW Dr. Cristiano Spada*, M.D., Catholic University, Rome, Italy presented the analysis, “Prospective Trial of PillCam COLON versus CT-Colonography (CTC) in the Evaluation of Patients with Incomplete Conventional Colonoscopy (CC)”.  After undergoing traditional colonoscopies that were unable to be completed for various reasons, 100 patients had PillCam COLON and CTC exams to determine how well doctors using each method were able to visualize areas of the colon that couldn’t be seen with the incomplete colonoscopy. PillCam COLON and CTC enabled physicians to see additional areas beyond colonoscopy in 98% of the patients. The results of this study suggested that both PillCam COLON and CTC are effective in patients with incomplete colonoscopies. However, PillCam COLON tends to detect more polyps than CTC in segments of the colon that were not visualized by incomplete colonoscopies.

Nearly as good as optical colonoscopy

Separately, Dr. Spada presented the results of a retrospective study, “Flat Colorectal Lesions At PillCam Colon Capsule Endoscopy (CCE)”, that indicates that PillCam COLON has high accuracy for detecting flat lesions, which have been shown to carry a higher risk for cancer. The retrospective study collected data from patients who underwent PillCam COLON followed by an optical colonoscopy, which is considered the gold standard tool for colorectal cancer detection. Physicians were able to identify 27 conventional polyps with colonoscopy, while they found 25 conventional polyps with PillCam COLON. In one patient, PillCam COLON visualized an 11 mm flat lesion that was not confirmed by colonoscopy. PillCam COLON generated 90% sensitivity and 96% specificity on a per-lesion basis.

“Clinical evidence continues to highlight the accuracy of PillCam COLON in providing direct visualization of the colon,” said Dr Spada. “The analysis data from our prospective trial show that PillCam COLON can be beneficial and effective for patients with previous incomplete colonoscopies. We welcome new diagnostic tools that provide us with a solution for this patient segment.”

Pediatric Ulcerative Colitis 95% Sensitivity 

A veritable flurry of Pillcam related papers were presented at the event. “Evaluation of the Second Generation Colon Capsule Endoscopy (CCE-2) in Pediatric Ulcerative Colitis (UC)”, a study involving  that in thirty pediatric patients with known ulcerative colitis showed 95% sensitivity for PillCam COLON to detect colonic inflammation and 100% specificity in accurately ruling it out.

Outperforms MRE for Crohns small bowel lesions 

Additionally, investigators from Clinic Hospital in Barcelona, Spain presented their poster; “Capsule Endoscopy (CE) Is Superior to Magnetic Resonance Enterography (MRE) for the Assessment of Small Bowel Lesions in Crohn’s Disease Patients (CD): a Comparative Trial.” Thirty-four patients with established or suspected Crohn’s disease and indeterminate colitis were enrolled in the comparative trial. Following Magnetic Resonance Enterography(MRE), PillCam COLON was used in twenty-three patients while PillCam SB was used in the remaining eleven patients. By using capsule endoscopy, investigators identified small bowel lesions in twenty-eight patients while they found lesions in only twenty-two patients using MRE. Capsule endoscopy detected lesions in the first (distal duodenum) and middle portions of the small bowel in nine patients where physicians found no lesions in these areas with MRE. Based on these data, researchers concluded that capsule endoscopy is superior to MRE for detecting lesions in the first and middle portions of the small bowel in patients with Crohn’s disease.

All in all, it’s sounding like PillCam’s  generating a bit of noise.

Regulatory status

PillCam® COLON has received a CE Mark, but is pending FDA clearance and is not cleared for marketing or available for commercial distribution in the U.S.A., Japan and certain other countries.

Source: Given Imaging Ltd., Globe Newswire

*Dr. Cristiano Spada is a paid consultant of Given Imaging.