Clinical trial NCT01744509: PillCam Colon Capsule 2® (PCC2) in the Setting of Colorectal Cancer Screening Program
Official title: PillCam Colon Capsule 2® (PCC2) in the Setting of Colorectal Cancer Screening (CRC) Program: Comparison With a New Integrated Reference Standard
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study the investigators evaluate the sensitivity of PCC2 (PillCam Colon Capsule 2 (R)) in identifying significant polyps in a CRC (Colo Recatal Cancer) screening program (primary outcome measure).

Each enrolled patient underwent three procedures: colon capsule endoscopy, CT-colonography and optical colonoscopy. In this study the reference standard is represented by the segmental unblinded colonoscopy (the unblinding is based on results of both capsule endoscopy and Ct colonography) The investigators also evaluated the tolerability of PCC2 as compared to optical colonoscopy (OC) and CT-colonography (CTC).

Detailed description: Asymptomatic average risk subjects with positive iFOBT (immunochemical Fecal Occult Blood Test), participating the regional screening program, were offered to undergo PCC2 (PillCam Colon Capsule 2 (R)) followed, 21 days later, by CTC and OC performed on the same day. The number, size and location of significant polyps (\>6mm) identified by each procedure were compared with the reference standard (RS), which was represented by the segmental unblinded colonoscopy. The unblinding was based on the integration of CTC and PCC2 results. For the PPC2 the quality of the bowel preparation (adequate/inadequate) and the completeness of the examination (capsule excreted still working or visualization of the anal verge) were also reported. In order to evaluate the tolerability, each subject was asked to identify, among the 3 procedures performed, which was the less tolerated one and which one he would be willing to repeat.

Eligibility criteria: Inclusion Criteria:

* asymptomatic average risk subjects, participating the regional colon cancer screening program, with positive iFOBT referred for colonoscopy

Exclusion Criteria:

* presence of obstructive symptoms
* swallowing disorders
* presence of cardiac pacemaker

Primary outcomes:
measure: Sensitivity of PillCam Colon Capsule 2 (R) in identifying significant colonic polyps
timeFrame: participants are followed for about 1 month
Secondary outcomes:
measure: to evaluate the tolerability of PCC2 as compared to optical colonoscopy (OC) and CT-colonography (CTC).
timeFrame: participants are followed for about 1 month
Other outcomes:
Locations:
city: Como
country: Italy
facility: Ospedale Valduce
Study officials:
affiliation: Gastroenterology Unit; Ospedale Valduce
name: Giancarlo Spinzi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rondonotti E, Borghi C, Mandelli G, Radaelli F, Paggi S, Amato A, Imperiali G, Terreni N, Lenoci N, Terruzzi V, Baccarin A, Martegani A, Spinzi G. Accuracy of capsule colonoscopy and computed tomographic colonography in individuals with positive results from the fecal occult blood test. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1303-10. doi: 10.1016/j.cgh.2013.12.027. Epub 2014 Jan 5.