Prospective multicenter performance evaluation of the second-generation colon capsule compared with colonoscopy.
OBJECTIVE
A second-generation capsule endoscopy system, using the PillCam Colon 2, was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system. The performance of this new system is reported.


METHODS
In a five-center feasibility study, second-generation capsule endoscopy was prospectively compared with conventional colonoscopy as gold standard for the detection of colorectal polyps and other colonic disease, in a cohort of patients scheduled for colonoscopy and having known or suspected colonic disease. Colonoscopy was independently performed within 10 hours after capsule ingestion. Capsule-positive but colonoscopy-negative cases were counted as false-positive.


RESULTS
104 patients (mean age 49.8 years) were enrolled; data from 98 were analyzed. Patient rate for polyps of any size was 44 %, 53 % of these patients having adenomas. No adverse events related to either procedure were reported. The capsule sensitivity for the detection of patients with polyps >or= 6 mm was 89 % (95 % confidence interval [CI] 70 - 97) and for those with polyps >or= 10 mm it was 88 % (95 %CI 56 - 98), with specificities of 76 % (95 %CI 72 - 78) and 89 % (95 %CI 86 - 90), respectively. Both polyps missed by colonoscopy and mismatch in polyp size by study definition lowered specificity. Overall colon cleanliness for capsule endoscopy was adequate in 78 % of patients (95 %CI 68 - 86).


CONCLUSIONS
The new second-generation colon capsule endoscopy is a safe and effective method for visualizing the colon and detecting colonic lesions. Sensitivity and specificity for detecting colorectal polyps appear to be very good, suggesting a potential for improved accuracy compared with the first-generation system. Further prospective and comparative studies are needed.
Eliakim
R
R
Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel. r_eliakim@rambam.health.gov.il
Yassin
K
K
Niv
Y
Y
Metzger
Y
Y
Lachter
J
J
Gal
E
E
Sapoznikov
B
B
Konikoff
F
F
Leichtmann
G
G
Fireman
Z
Z
Kopelman
Y
Y
Adler
S N
SN
D000293:Adolescent; D000328:Adult; D053704:Capsule Endoscopy; D002400:Cathartics / Q000008:administration & dosage; D003111:Colonic Polyps / Q000175:diagnosis*; D003113:Colonoscopy; D005189:False Positive Reactions; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage; D012680:Sensitivity and Specificity; D055815:Young Adult
D002400:Cathartics; D010710:Phosphates; D011092:Polyethylene Glycols; C018279:sodium phosphate