PillCam Shows Promise for Colorectal Screening

WASHINGTON — In a multicenter study, capsule endoscopy showed promise in the detection of significant colorectal polyps, and the technique may someday offer a noninvasive alternative to conventional colonoscopy, Dr. Jacques Devière said at the annual Digestive Disease Week.

For significant lesions—those greater than 6 mm in size—or in patients with three or more polyps, the sensitivity of capsule endoscopy using the PillCam COLON was 79% and specificity was 78%, compared with conventional colonoscopy. The positive predictive value (PPV) was 75%, and the negative predictive value (NPV) was 82%, Dr. Devière reported.

A total of 275 polyps were identified with the PillCam. For polyps of any size, the PillCam had a sensitivity and specificity of 76%. PPV was 88% and NPV was 58%.

If validated, “this noninvasive technology might challenge colonoscopy for colon cancer screening and polyp detection in the future,” said Dr. Devière, a gastroenterologist at the Hôpital Erasme in Brussels.

The study was sponsored by Given Imaging Ltd., maker of the PillCam COLON. Dr. Devière disclosed that he has received research support from the company.

A total of 84 patients at eight centers were included; 64% were male, and the average age was 60 years. Patients were included if they had an adenoma and were asked to come back for surveillance after 3 years, or if they were suspected of having colonic disease and were referred for conventional colonoscopy. Patients were excluded if they had Crohn's disease, small bowel tumors, radiation enteritis, or surgical anastomoses.

On the day before the procedure, patients were limited to a clear liquid diet. In the evening, they drank 4 L of polyethylene glycol preparation (Colopeg).

At 7 a.m. the next day, patients drank another liter of Colopeg, followed by 20 mg of domperidone (to aid excretion of the capsule). They swallowed the capsule an hour later. At 10 a.m., patients drank a “booster” of 45 mL sodium phosphate.

Using this regimen, 77% of patients excreted the capsule by 2 p.m. The remaining patients required a second booster of 30 mL sodium phosphate. Patients were allowed a low-fiber snack at 3 p.m. If the capsule had not been excreted by 4:30 p.m., patients received 10 mg bisacodyl.

Conventional colonoscopy was performed in all patients after the capsule was excreted that day in order to allow comparisons to be made between the two methods.

Colon preparation was rated as poor, fair, good, or excellent. Preparation was considered poor if there was a large amount of fecal residue that impaired visualization, fair if there were enough areas of evacuation to allow a reliable examination, good if there was only a small amount of residue, and excellent if no or very small amounts of residue were present.

Most patients (57%) had a good preparation, followed by 29% with a fair prep, 9% with an excellent prep, and 5% with a poor prep. “There is still some problem with the quality of the preparation,” Dr. Devière said.

By the end of the battery life (10 hours), 92% of the capsules had been excreted and 4% were still in the sigmoid colon; two capsules were never eliminated from the stomach because the patients had gastroparesis. In these two patients, additional endoscopies had to be performed to push the capsules out of the stomach.

The capsule measures 11 mm by 31 mm—roughly the size of a large vitamin pill—and it has tiny cameras that capture four images per second. The capsule has a sleep mode of 2 hours to preserve the battery between the time it is swallowed and the approximate time it enters the colon.

WASHINGTON — In a multicenter study, capsule endoscopy showed promise in the detection of significant colorectal polyps, and the technique may someday offer a noninvasive alternative to conventional colonoscopy, Dr. Jacques Devière said at the annual Digestive Disease Week.

For significant lesions—those greater than 6 mm in size—or in patients with three or more polyps, the sensitivity of capsule endoscopy using the PillCam COLON was 79% and specificity was 78%, compared with conventional colonoscopy. The positive predictive value (PPV) was 75%, and the negative predictive value (NPV) was 82%, Dr. Devière reported.

A total of 275 polyps were identified with the PillCam. For polyps of any size, the PillCam had a sensitivity and specificity of 76%. PPV was 88% and NPV was 58%.

If validated, “this noninvasive technology might challenge colonoscopy for colon cancer screening and polyp detection in the future,” said Dr. Devière, a gastroenterologist at the Hôpital Erasme in Brussels.

The study was sponsored by Given Imaging Ltd., maker of the PillCam COLON. Dr. Devière disclosed that he has received research support from the company.

A total of 84 patients at eight centers were included; 64% were male, and the average age was 60 years. Patients were included if they had an adenoma and were asked to come back for surveillance after 3 years, or if they were suspected of having colonic disease and were referred for conventional colonoscopy. Patients were excluded if they had Crohn's disease, small bowel tumors, radiation enteritis, or surgical anastomoses.

On the day before the procedure, patients were limited to a clear liquid diet. In the evening, they drank 4 L of polyethylene glycol preparation (Colopeg).

At 7 a.m. the next day, patients drank another liter of Colopeg, followed by 20 mg of domperidone (to aid excretion of the capsule). They swallowed the capsule an hour later. At 10 a.m., patients drank a “booster” of 45 mL sodium phosphate.

Using this regimen, 77% of patients excreted the capsule by 2 p.m. The remaining patients required a second booster of 30 mL sodium phosphate. Patients were allowed a low-fiber snack at 3 p.m. If the capsule had not been excreted by 4:30 p.m., patients received 10 mg bisacodyl.

Conventional colonoscopy was performed in all patients after the capsule was excreted that day in order to allow comparisons to be made between the two methods.

Colon preparation was rated as poor, fair, good, or excellent. Preparation was considered poor if there was a large amount of fecal residue that impaired visualization, fair if there were enough areas of evacuation to allow a reliable examination, good if there was only a small amount of residue, and excellent if no or very small amounts of residue were present.

Most patients (57%) had a good preparation, followed by 29% with a fair prep, 9% with an excellent prep, and 5% with a poor prep. “There is still some problem with the quality of the preparation,” Dr. Devière said.

By the end of the battery life (10 hours), 92% of the capsules had been excreted and 4% were still in the sigmoid colon; two capsules were never eliminated from the stomach because the patients had gastroparesis. In these two patients, additional endoscopies had to be performed to push the capsules out of the stomach.

The capsule measures 11 mm by 31 mm—roughly the size of a large vitamin pill—and it has tiny cameras that capture four images per second. The capsule has a sleep mode of 2 hours to preserve the battery between the time it is swallowed and the approximate time it enters the colon.

WASHINGTON — In a multicenter study, capsule endoscopy showed promise in the detection of significant colorectal polyps, and the technique may someday offer a noninvasive alternative to conventional colonoscopy, Dr. Jacques Devière said at the annual Digestive Disease Week.

For significant lesions—those greater than 6 mm in size—or in patients with three or more polyps, the sensitivity of capsule endoscopy using the PillCam COLON was 79% and specificity was 78%, compared with conventional colonoscopy. The positive predictive value (PPV) was 75%, and the negative predictive value (NPV) was 82%, Dr. Devière reported.

A total of 275 polyps were identified with the PillCam. For polyps of any size, the PillCam had a sensitivity and specificity of 76%. PPV was 88% and NPV was 58%.

If validated, “this noninvasive technology might challenge colonoscopy for colon cancer screening and polyp detection in the future,” said Dr. Devière, a gastroenterologist at the Hôpital Erasme in Brussels.

The study was sponsored by Given Imaging Ltd., maker of the PillCam COLON. Dr. Devière disclosed that he has received research support from the company.

A total of 84 patients at eight centers were included; 64% were male, and the average age was 60 years. Patients were included if they had an adenoma and were asked to come back for surveillance after 3 years, or if they were suspected of having colonic disease and were referred for conventional colonoscopy. Patients were excluded if they had Crohn's disease, small bowel tumors, radiation enteritis, or surgical anastomoses.

On the day before the procedure, patients were limited to a clear liquid diet. In the evening, they drank 4 L of polyethylene glycol preparation (Colopeg).

At 7 a.m. the next day, patients drank another liter of Colopeg, followed by 20 mg of domperidone (to aid excretion of the capsule). They swallowed the capsule an hour later. At 10 a.m., patients drank a “booster” of 45 mL sodium phosphate.

Using this regimen, 77% of patients excreted the capsule by 2 p.m. The remaining patients required a second booster of 30 mL sodium phosphate. Patients were allowed a low-fiber snack at 3 p.m. If the capsule had not been excreted by 4:30 p.m., patients received 10 mg bisacodyl.

Conventional colonoscopy was performed in all patients after the capsule was excreted that day in order to allow comparisons to be made between the two methods.

Colon preparation was rated as poor, fair, good, or excellent. Preparation was considered poor if there was a large amount of fecal residue that impaired visualization, fair if there were enough areas of evacuation to allow a reliable examination, good if there was only a small amount of residue, and excellent if no or very small amounts of residue were present.

Most patients (57%) had a good preparation, followed by 29% with a fair prep, 9% with an excellent prep, and 5% with a poor prep. “There is still some problem with the quality of the preparation,” Dr. Devière said.

By the end of the battery life (10 hours), 92% of the capsules had been excreted and 4% were still in the sigmoid colon; two capsules were never eliminated from the stomach because the patients had gastroparesis. In these two patients, additional endoscopies had to be performed to push the capsules out of the stomach.

The capsule measures 11 mm by 31 mm—roughly the size of a large vitamin pill—and it has tiny cameras that capture four images per second. The capsule has a sleep mode of 2 hours to preserve the battery between the time it is swallowed and the approximate time it enters the colon.