Rapid and accurate
The researchers determined the efficiency of the capsule in correctly detecting a UGIB. The capsule’s positive and negative predictive values were 74.3% and 97.8%, respectively.
“We achieved a sensitivity of around 93% (92.9%; P = 0.024) with the PillSense capsule and a specificity of 91% (90.6%; P < .001]), which were pretty good. We also detected a range from minimal bleeding – so, speckles of blood to large amounts of active bleeding covering the entire stomach,” reported Dr. Akiki.
There were no differences in terms of patient demographics, laboratory results, or concomitant use of medications. PillSense recording time was a mean of 6.71 minutes, the time from capsule ingestion to EGD was a mean of 55 minutes, and the time to capsule passage through the GI tract was 3.6 days. Most bleeds were found to be in the stomach (18/30; 60%), followed by the duodenum (5/30; 16.6%).
Various capsules for detecting UGIB are under development or are already available, but unlike some of the others, “[the PillSense] is not a video capsule,” said Dr. Akiki. “It does not take pictures at all but is more of a photo sensor capsule that measures the absorption of wavelengths.”
This explains why the PillSense was so rapid – results were available in around 7 minutes and did not require an interpretation by a physician, he explained. “Trained non-physician personnel can use it, and this is where it differs from other devices, such as video capsules that require someone highly trained to interpret the output. It’s an easy procedure and process to follow.”
The PillSense has value in improving workflow, Dr. Akiki said. “If we had someone come in during the night with a suspected upper GI bleed, we could give them the capsule, determine if they need an EGD or not, and potentially postpone it to a time – say, the morning, when more resources are available – freeing up the night for emergency cases. It helps me, as a physician, to determine which patients to send to EGD immediately or which to wait.”
He added that more studies are needed in the postmarketing phase to understand optimal use of the device and to define the exact clinical pathway for optimal implementation.
The device was approved by the U.S. Food and Drug Administration in February. Dr. Akiki noted that there were no adverse events or deaths related to the capsule.
Co-moderator, Philip Chiu, MD, a gastroenterologist from the Chinese University of Hong Kong, said, “It’s an interesting study, because sometimes we can’t differentiate by clinical symptoms as to whether this is a problem of continuous bleeding or something else. The capsule might help us in our decision-making in this respect and help determine whether we should scope the patients or just manage conservatively.”
Dr. Akiki and Dr. Chiu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
