Porovnání účinnosti kolonické kapslové endoskopie a kolonoskopie v detekci polypů a karcinomů tlustého střeva a konečníku - Multicentrická, prospektivní, cross-over studie
Abstrakt
The national colorectal cancer screening program has been running in the Czech Republic (CR) since 2000. It is based on an examination by faecal occult blood test (FOBT) and colonoscopy.
In 2012 the target population coverage reached the level of 25.8%. The European guidelines set the acceptable participation rate to at least 45%, and the recommended aim is 65%.
For this reason, other screening modalities are examined. Capsule colonoscopy is one of these possible methods.
In CR, a multicentre study has been running since 2011. Its interim analysis is presented here.
The main aim of the study was to assess the accuracy of second-generation capsule colonoscopy (CCE2) in detection of colorectal neoplasia (polyps, adenomas, cancers) in comparison to colonoscopy (OC). The secondary aims were: comparison of colon cleansing, number of complications and target population acceptance of both methods (CCE2 and OC).
Material and methods: Individuals examined prospectively in years 2011-2014 at four specialized endoscopy centres by capsule colonoscopy and optical colonoscopy (standard method) were enrolled. Only the "screening population" was included: asymptomatic persons aged over 50, with no personal or familial history of colorectal neoplasia.
The primary outcomes were the accuracy of detection of all polyps; polyps GREATER-THAN OR EQUAL TO 6 mm and GREATER-THAN OR EQUAL TO 10 mm; adenomas GREATER-THAN OR EQUAL TO 10 mm and cancers. Colon cleansing was grouped to adequate and inadequate.
Complications were assessed as serious (bleeding, perforation) and mild. Acceptance of the methods was evaluated based on a patient questionnaire filled in after both procedures (CCE2 and OC) were finished.
Results: In total, 203 individuals (109 men, 54%; 94 women, 46%; mean age 59 years) were enrolled. 175 (86%) of them underwent the complete examination and were further analysed. During optical colonoscopy polyps were diagnosed in 83 persons (47%), polyps GREATER-THAN OR EQUAL TO 6 mm and GREATER-THAN OR EQUAL TO 10 mm in 25 (14%) and 11 (6%) patients, respectively.
In 40 (23%) patients the adenoma was diagnosed, in seven (4%) its size was GREATER-THAN OR EQUAL TO 10 mm. The sensitivity of CCE2 for polyps GREATER-THAN OR EQUAL TO 6 mm and GREATER-THAN OR EQUAL TO 10 mm and adenomas GREATER-THAN OR EQUAL TO 10 mm reached 76%, 91% and 100%, respectively.
The specificity for polyps GREATER-THAN OR EQUAL TO 6 mm and GREATER-THAN OR EQUAL TO 10 mm was 97% and 98%, respectively. Only one cancer was diagnosed at both CCE2 and OC.
There were no serious complications registered. Adequate colon cleansing was achieved in 87% (CCE2) and 91% (OC) individuals. 46% of people preferred colon capsule as the primary screening test.
Conclusion: Colon capsule is a safe, non-invasive and sensitive method for diagnosis of colorectal neoplasia. It is acceptable as the primary test for colorectal cancer screening.