The comparison of the efficiency of colon capsule endoscopy and optical colonoscopy in patients with positive immunochemical faecal occult blood test – multicentre, prospective study

Česká verzia

Authors: M. Voška ¹; T. Grega ¹; G. Vojtěchová ¹ ; O. Ngo ²; O. Májek ²; B. Bučková ²; I. Tachecí ³; M. Beneš ⁴; J. Bureš ³; J. Špičák ⁴; M. Zavoral ¹; Š. Suchánek ¹
Authors place of work: Interní klinika 1. LF UK a ÚVN, Praha ¹; Institut biostatistiky a analýz, LF MU, Brno ²; II. interní gastroenterologická klinika, LF UK a FN Hradec Králové ³; Klinika hepatogastroenterologie, Transplantcentrum, IKEM, Praha ⁴
Published in the journal: Gastroent Hepatol 2018; 72(4): 298-303
Category: Clinical and Experimental Gastroenterology: Original Article
doi: https://doi.org/10.14735/amgh2018298

Summary

Background:

Faecal immunochemical tests (FIT) have been used as an initial test in colorectal screening programmes. However, the majority of patients do not have advanced neoplasia on colonoscopy. Colon capsule endoscopy (CCE) has the potential to reduce the need for optical colonoscopy (OC).

Aim:

The aim of the study was negative predictive value (NPV) of the second generation of colon capsule endoscopy (CCE2) for large polyps (≥ 10 mm). The secondary aims were: accuracy of detection of all polyps (polyps ≥ 6 mm and ≥ 10 mm) and cancers, number of complications and target population acceptance of both methods (CCE2 and OC).

Material and methods:

In this multicentre (3 gastroenterology units) feasibility study, 2^nd generation of colon capsule endoscopy (CCE2) has been prospectively compared with OC in persons with positive semi-quantitative FIT with cut-off level 75 ng/ml. Colonoscopy was performed within 10 hours after capsule ingestion. CCE2 videos were viewed independently by a nurse and a physician, both blinded to the results of OC. Complications were assessed as serious (bleeding, perforation) or mild to moderate. The methods of acceptance were evaluated based on the questionnaire completed after both procedures (CCE2 and OC) were finished. The interim analysis of results is presented.

Results:

From April 2016, 111 individuals have been enrolled, data from 54 persons have been analysed. During optical colonoscopy, polyps were diagnosed in 37 persons (69%), polyps ≥ 6 mm and ≥ 10 mm in 22 (41%) and 12 (22%) persons, resp. The sensitivity of CCE2 for polyps ≥ 6 mm and ≥ 10 mm was 82% (95% confidence interval – CI 60–95%) and 75% (95% CI 43–95%), resp. The specificity for polyps ≥ 6 mm and ≥ 10 mm reached 88% (95% CI 71–96%) and 93% (95% CI 81–99%), resp. There were 2 cancer diagnoses at both CCE2 and OC. The negative predictive value of CCE2 for polyps ≥ 10 mm was 93% (95% CI 81–99%). Nurses identified 17 polyps ≥ 6 mm of 22 (77%) and 10 polyps ≥ 10 mm of 12 (83%) found on OC. There was 1 stagnation of colon capsule in stenosing tumour of ascending colon recorded. No patient had any serious adverse event that was related to both methods. A total of 40 patients (75%) preferred CCE2 as the primary screening method. Conclusion: Second generation of colon capsule has appeared to have a high negative predictive value for the detection of clinically relevant colorectal neoplasia in screening population. This method might be considered as an adequate tool for colorectal cancer screening.

Key words:

colorectal cancer – colon capsule endoscopy – optical colonoscopy – faecal immunochemical tests – accuracy

The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE „uniform requirements“ for bio medical papers.

Submitted: 21. 6. 2018

Accepted: 13. 8. 2018

Zdroje

1. Dušek L, Mužík J, Pavlík T et al. Epidemiologie zhoubných nádorů trávicího traktu v České republice – současný stav a predikce. Gastroent Hepatol 2012; 66 (5): 331–339.

2. Zavoral M, Suchánek Š, Májek O et al. Národní program screeningu kolorektálního karcinomu v České republice – minulost, přítomnost a budoucnost. Gastroent Hepatol 2012; 66 (5): 345–349.

3. von Karsa L, Patnick J, European Colorectal Cancer Screening Guidelines Working Group et al. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy 2013; 45 (1): 51–59. doi: 10.1055/s-0032-1325997.

4. Spada C, Riccioni ME, Hassan C et al. PillCam colon capsule endoscopy: a prospective, randomized trial comparing two regimens of preparation. J Clin Gastroenterol 2011; 45 (2): 119–124. doi: 10.1097/MCG.0b013e3181dac 04b.

5. Spada C, Hassan C, Galmiche JP et al. Colon capsule endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2012; 44 (5): 527–536. doi: 10.1055/s-0031-1291717.

6. The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon: November 30 to December 1, 2002. Gastrointest Endosc 2003; 58 (Suppl 6): S3–43.

7. Kaminski MF, Regula J, Kraszewska E et al. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med 2010; 362 (19): 1795–1803. doi: 10.1056/NEJMoa0907 667.

8. Eliakim R, Fireman Z, Gralnek IM et al. Evaluation of the PillCam Colon capsule in the detection of colonic pathology: results of the first multicenter, prospective, comparative study. Endoscopy 2006; 38 (10): 963−970. doi: 10.1055/s-2006-944832.

9. Van Gossum A, Munoz-Navas M, Fernandez-Urien I et al. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med 2009; 361 (3): 264–270. doi: 10.1056/NEJMoa0806347.

10. Eliakim R, Yassin K, Niv Y et al. Prospective multicenter performance evaluation of the second-generation colon capsule compared with colonoscopy. Endoscopy 2009; 41 (12): 1026–1031. doi: 10.1055/s-0029-1215360.

11. Spada C, Hassan C, Munoz-Navas M et al. Second-generation colon capsule endoscopy compared with colonoscopy. Gastrointest Endosc 2011; 74 (3): 581–589. doi: 10.1016/j.gie.2011.03.1125.

12. Rex DK, Adler SN, Aisenberg J et al. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. Gastroenterology 2015; 148 (5): 948–957. doi: 10.1053/j.gastro.2015.01.025.

13. Zavoral M, Májek O, Tachecí I et al. Porovnání účinnosti kolonické kapslové endoskopie a kolonoskopie v detekci polypů a karcinomů tlustého střeva a konečníku – multicentrická, prospektivní, cross-over studie. Gastroent Hepatol 2014; 68 (3): 218−224.

14. Rezapour M, Amadi C, Gerson LB et al. Retention associated with video capsule endoscopy: systematic review and meta-analysis. Gastrointest Endosc 2017; 85 (6): 1157–1168. doi: 10.1016/j.gie.2016.12.024.