Small-bowel capsule endoscopy: A ten-point contemporary review

Table 9 Studies looking at the clinical validity of Fujinon^® intelligent chromoendoscopy enhancement/Blue mode, feature of capsule endoscopy reading software, in small-bowel capsule endoscopy

Ref.	Country	Centre	Study type	Objective(s)	Design	Images	FICE	CE	Outcome(s)
Imagawa et al[114]	Japan	Single centre	Retrospective	Assess whether visualization of SB lesions improves with FICE	►5 experienced readers compared CE-WL images to their FICE counterparts	►Angiectasis (n = 23);	FICE 1,2,3	PillCam®SB1; Given®Imaging Ltd.	►FICE 1: AVMs: improvement in 87% (20/23) cases; erosion/ulceration: improvement 53.3% (26/47) cases; tumour images: improvement 25.3% (19/75) cases;
						►Erosion/ulcers (n = 47);
									►FICE 2: AVMs: improvement in 87% (20/23) cases; erosion/ulceration: improvement in 25.5% (12/47) cases; tumour images: improvement in 20.0% (15/75) cases;
						►Tumour (n = 75)
									►FICE 3: All images groups: only equivalence achieved in all cases; intra-observer agreement: good to satisfactory (5.4 or higher)
Imagawa et al[115]	Japan	Single centre	Prospective	Assess whether FICE improves detection rate of SB lesions in CE	►A CE reader reviewed CE-WL videos;	50 pts	FICE 1,2,3	PillCam®SB1; Given®Imaging Ltd.	►Angioectasias detection: CE-WL: 17 AVMs; CE-FICE 1: 48 AVMs; CE-FICE 2: 45 AVMs; CE-FICE 3: 24 AVMs; significant CE-FICE 1 and 2 (P = 0.0003 and P < 0.0001, respectively)
					►Another reader, reviewed CE-FICE videos with FICE 1,2,3
									►Detection rate for erosion, ulceration and tumour did not differ statistically between CE-WL and CE-FICE 1,2,3;
Gupta et al[116]	Belgium	Single centre	Retrospective	Assess potential benefit of FICE for SB lesion detection in patients with OGIB	CE videos analysed by 2 GI fellows with and without FICE 1,2,3;	60 pts with OGIB	FICE 1,2,3	PillCam®SB1; Given®Imaging Ltd.	►Overall, 157 lesions diagnosed with CE-FICE vs 114 with CE-WL (P = 0.15);
									►For P2 lesions; CE-FICE Sens/Spec: 94%/95% vs CE-WL Sens/Spec: 97%/96%, respectively; 5/55 AVMs better characterized with CE-FICE than CE-WL
					Reference standard: Senior consultant described findings as P0, P1 and P2 lesions
									►More P0 diagnosed by CE-FICE than CE-WL (39 vs 8, P < 0.001);
									►Intra-class kappa correlations between fellows and reference: CE-FICE vs CE-WL for P2 lesions: 0.88 vs 0.92; CE-FICE vs CE-WL for P1 lesions: 0.61 vs 0.79
Krystallis et al[117]	United Kingdom	Single centre	Retrospective	Assess FICE and Blue mode visualisation of SB lesions in CE	►2 experienced reviewers CE-WL images to FICE/Blue mode counterparts	►Angioectasias (n = 18);	Blue mode; FICE 1,2,3	Pillcam®SB1/SB2; Given®Imaging Ltd.	►Total of 167 images, for all lesion categories:
						►Erosion/ulcers (n = 60);			►Blue mode vs WL: image improvement in 83%; κ = 0.786
						►Villi oedema (n = 17);			►FICE 1 vs WL: image improvement in 34%; κ = 0.646
						►Cobblestone (n = 11);			►FICE 2 vs WL: image improvement in 8.6%; κ = 0.617
						►Blood lumen (n = 15);			►FICE 3 vs WL: image improvement in 7.7%; κ = 0.669
						►LICS/other (n = 46)
Duque et al[118]	Portugal	Single centre	Prospective	Assess reproducibility and diagnostic accuracy of CE-FICE	►4 physicians reviewed 150 FICE images;	20 patients with OGIB	Blue mode; FICE 1,2,3	PillCam®SB2; Given®Imaging Ltd.	►Concordance between the 4 gastroenterologists: 0.650;
									►CE-WL identified 75 findings and the CE-FICE 95;
					►2 experienced physicians analysed 20 CE; 1 interpreted CE-WL; the other, CE-FICE videos				►CE-FICE did not miss any lesions identified by CE-WL and allowed the identification of a higher number of AVMs (35 vs 32) and erosions (41 vs 24)
Nakamura et al[119]	Japan	Single centre	Prospective	Assess preview of angioectasias by CE-FICE preview (compared to CE-WL)	►One experienced physician analysed CEs in QuickView mode;	50 pts with angiodysplasia were randomly assigned to 2 equally sized groups of CE-WL reading and CE-FICE reading	SBI; Blue mode; FICE 1,2,3	PillCam®SB2; Given®Imaging Ltd.	►Mean reading time: 14min for both CE-WL and CE-FICE reading;
									►The two previews for angiodysplasia were significantly superior to the function of SBI (P < 0.01);
					►Mean reading time, sensitivity and specificity for angiodysplasia detection were evaluated including SBI
									►Sens and Spec of CE-WL: 80% and 100%, respectively;
									►Sens and Spec of CE-FICE: 91% and 86%, respectively;
									►FICE reading was superior in Sens, while it resulted in more false (+) ve lesion findings and lower Spec
Sakai et al[120]	Japan	Single centre	Prospective	►Assess whether CE-FICE improves detectability of SB lesions by CE trainees and if it contributes to reducing the bile-pigment effect;	►4 gastroenterology trainees interpreted 12 CE videos with WL and FICE 1,2,3;	►60 AVMs; ►82 erosions/ulcers	FICE 1,2,3	PillCam®SB2; Given®Imaging Ltd.	►60 angioectasias; CE trainees identified: 26 by CE-WL, 40 by CE-FICE1, 38 by CE-FICE2, 31 by CE-FICE3;
									►82 erosions/ulcerations, CE trainees identified: 38 by CE-WL, 62 by CE-FICE1, 60 CE- FICE2, 20 by CE-FICE3;
					►Lesion detection rate under each of the three FICE settings was compared with that by conventional CE-WL
									►CE-FICE 1 and 2 significantly improved detectability of angioectasias (P = 0.0017 and P = 0.014, respectively) and erosions/ulcers (P = 0.0012 and P = 0.0094, respectively);
				►Evaluate whether poor bowel preparing affects the accuracy of lesion recognition by FICE					►Detectability of SB lesions by CE-FICE1 was not affected (P = 0.59) by the presence of bile-pigments;
									►Detectability of SB lesions by CE-WL (P = 0.020) and CE-FICE2 (P = 0.0023) was reduced by the presence of bile-pigments;
									►In poor bowel visibility conditions, CE-FICE yielded a high rate of false-positive findings

FICE: Fujinon^® Intelligent chromoendoscopy enhancement; CE: Capsule endoscopy; SB: Small bowel; WL: White light; OGIB: Obscure gastrointestinal bleeding; SBI: Suspected Blood Indicator; AVM: arterio-venous malformation; κ: Inter-observer agreement; LICS: Lesions of indeterminate clinical significance; Sens: Sensitivity; Spec: Specificity.