daw
11-09-2004, 02:57 PM
Esophageal Capsule Endoscopy Demonstrates Efficacy for Barrett's Screening
byPeggy Peck
Nov. 2, 2004 (Orlando) — Results from a study evaluating traditional upper endoscopy compared with the M2A esophageal capsule endoscope (PillCam; ECE) suggest that the ECE is an effective and "patient friendly" option for screening patients at high risk of Barrett's esophagus.
Raul Eliakim, MD, an associate professor of medicine and chief of gastroenterology at the Rambam Medical Center in Haifa, Israel, presented the results during the Presidential Plenary Session at the 69th annual scientific meeting of the American College of Gastroenterology (ACG).
Dr. Eliakim told Medscape that overall the ECE demonstrated a sensitivity of 92%, a specificity of 95%, a positive predictive value (PPV) of 97%, and a negative predictive value (NPV) of 88%. For Barrett's esophagitis, "the capsule identified 32 of 33 Barrett's patients, which was a sensitivity of 97%; [a] specificity of 99%; PPV, 97%; and NPV, 99%," he said. The results for esphagitis were similar: the ECE identified 33 of 37 patients, demonstrating a sensitivity of 89%; a specificity of 99%; PPV, 97%; and NPV, 94%.
The ECE could improve the screening rate for Barrett's esophagus because unlike traditional endoscopy, "no fasting and no sedation are required," Dr. Eliakim said. "The patient simply swallowed the capsule in a supine position. After two minutes in a supine position, the patient is raised to a 30º angle for two more minutes, then up to 60º for one minute, and then the patient can stand. It takes five minutes, and the patient is on his way."
The capsule has camera ports on both ends, and it transmits "four pictures a second so the mean number of images is 980 as it transits the esophagus," Dr. Eliakim said.
The esophageal capsule, which is made by Given Imaging and marketed as PillCam ESO, requires three sensors, which is about half the number required for the PillCam SB, the device used to image the small intestine. PillCam ESO received U.S. Food and Drug Administration approval on Oct. 26.
The multicenter study recruited 106 patients with gastroesophageal reflux diease. Patients underwent both ECE and traditional endoscopy. The patients fasted for six hours and then were imaged using the capsules. After the ECE imaging, patients underwent conscious sedation for endoscopy. "The operators reading the endoscopy were blinded to the capsule results and the operators interpreting the capsule results were blinded to the endoscopy findings," Dr. Eliakim said.
Douglas K. Rex, MD, a professor of medicine at Indiana University School of Medicine in Indianapolis, and outgoing president of ACG, told Medscape that "patients will love this [capsule endoscopy] because it is so convenient." But he noted that unlike traditional endoscopy, the capsule is "only diagnostic. You cannot do biopsies with the capsule, which means that if you have a positive finding on capsule you are going to need endoscopy anyway," explained Dr. Rex, who was not involved in the study.
During the discussion period, Dr. Eliakim was asked about cost of the ECE, which he declined to estimate. But Harris Clearfield, MD, a professor of medicine at Drexel University in Philadelphia, predicted that the capsules will probably cost about "the same as the small intestine capsules —that is about $500. That is probably too expensive to be widely used for screening. If the cost came down to $200 or $250 it would be an attractive screening option for high-risk patients." Dr. Clearfield was not involved in the study.
The study was funded by Given Imaging.
ACG 69th Annual Scientific Meeting: Abstract 1. Presented Nov. 1, 2004.
Reviewed by Gary D. Vogin, MD
byPeggy Peck
Nov. 2, 2004 (Orlando) — Results from a study evaluating traditional upper endoscopy compared with the M2A esophageal capsule endoscope (PillCam; ECE) suggest that the ECE is an effective and "patient friendly" option for screening patients at high risk of Barrett's esophagus.
Raul Eliakim, MD, an associate professor of medicine and chief of gastroenterology at the Rambam Medical Center in Haifa, Israel, presented the results during the Presidential Plenary Session at the 69th annual scientific meeting of the American College of Gastroenterology (ACG).
Dr. Eliakim told Medscape that overall the ECE demonstrated a sensitivity of 92%, a specificity of 95%, a positive predictive value (PPV) of 97%, and a negative predictive value (NPV) of 88%. For Barrett's esophagitis, "the capsule identified 32 of 33 Barrett's patients, which was a sensitivity of 97%; [a] specificity of 99%; PPV, 97%; and NPV, 99%," he said. The results for esphagitis were similar: the ECE identified 33 of 37 patients, demonstrating a sensitivity of 89%; a specificity of 99%; PPV, 97%; and NPV, 94%.
The ECE could improve the screening rate for Barrett's esophagus because unlike traditional endoscopy, "no fasting and no sedation are required," Dr. Eliakim said. "The patient simply swallowed the capsule in a supine position. After two minutes in a supine position, the patient is raised to a 30º angle for two more minutes, then up to 60º for one minute, and then the patient can stand. It takes five minutes, and the patient is on his way."
The capsule has camera ports on both ends, and it transmits "four pictures a second so the mean number of images is 980 as it transits the esophagus," Dr. Eliakim said.
The esophageal capsule, which is made by Given Imaging and marketed as PillCam ESO, requires three sensors, which is about half the number required for the PillCam SB, the device used to image the small intestine. PillCam ESO received U.S. Food and Drug Administration approval on Oct. 26.
The multicenter study recruited 106 patients with gastroesophageal reflux diease. Patients underwent both ECE and traditional endoscopy. The patients fasted for six hours and then were imaged using the capsules. After the ECE imaging, patients underwent conscious sedation for endoscopy. "The operators reading the endoscopy were blinded to the capsule results and the operators interpreting the capsule results were blinded to the endoscopy findings," Dr. Eliakim said.
Douglas K. Rex, MD, a professor of medicine at Indiana University School of Medicine in Indianapolis, and outgoing president of ACG, told Medscape that "patients will love this [capsule endoscopy] because it is so convenient." But he noted that unlike traditional endoscopy, the capsule is "only diagnostic. You cannot do biopsies with the capsule, which means that if you have a positive finding on capsule you are going to need endoscopy anyway," explained Dr. Rex, who was not involved in the study.
During the discussion period, Dr. Eliakim was asked about cost of the ECE, which he declined to estimate. But Harris Clearfield, MD, a professor of medicine at Drexel University in Philadelphia, predicted that the capsules will probably cost about "the same as the small intestine capsules —that is about $500. That is probably too expensive to be widely used for screening. If the cost came down to $200 or $250 it would be an attractive screening option for high-risk patients." Dr. Clearfield was not involved in the study.
The study was funded by Given Imaging.
ACG 69th Annual Scientific Meeting: Abstract 1. Presented Nov. 1, 2004.
Reviewed by Gary D. Vogin, MD