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. 2023 Jun 12;13(12):2032. doi: 10.3390/diagnostics13122032

Table 1.

Studies of the use of Pillcam Crohn’s Capsule in CD.

Author (Year) Study Population Study Design Topic Findings
Leighton et al., 2017 [12] 114 Prospective, multicentre Comparison of diagnostic yield of PCE vs. IC for active CD lesions. The diagnostic yield rate for active CD lesions was 83.3% for PCE and 69.7% for IC.
PCE detection rates for active CD in the TI, caecum, ascending colon, transverse colon, descending/sigmoid colon, and rectum were 70, 38, 36, 30, 39, and 29%.
IC was less sensitive with detection rates of 54, 26, 34, 24, 31, and 25%, respectively.
Eliakim et al., 2018 [13] 41 Prospective, multicentre Feasibility study with a primary endpoint of successful video creation and report creation. The secondary endpoints were entire bowel inspection, duration of reading time, video quality, and adverse events. All 41 videos met the primary endpoint. There was no capsule retention. Bowel coverage was graded 6.7 ± 0.6 and 6.1 ± 1.3 (1–7, unconfident–confident), image quality was graded 6.1 ± 0.8 (1–7, poor–excellent), and reading time was graded 3.7 ± 1.4 (1–7, very short to very long).
Adler et al., 2019 [14] 30 Prospective, multicentre Comparison of PCE and colonoscopy in UC. Moderate agreement for disease extent in UC in 56.5% of cases (kappa coefficient 0.42) with very good agreement for assessment of UC disease activity based on Mayo endoscopic subscore in 95.7% of cases (kappa coefficient 0.86).
Bruining et al., 2020 [15] 158 Prospective, multicentre This study assessed the accuracy and safety of PCE in CD compared with IC and/or MRE. PCE was equally sensitive to MRE and/or IC for active enteric inflammation (94 vs. 100%, p = 0.125) and more specific (74 vs. 22%, p = 0.001). The sensitivity of PCE was superior to that of MRE for enteric inflammation in the proximal small bowel (97 vs. 71%, p = 0.021) and similar to that of MRE and/or IC in the TI and colon.
Tontini et al., 2020 [8] 41 Prospective, multicentre Comparison of diagnostic performance of PCC (with two cameras offering a 344° panoramic view) vs. the standard 172° view (one camera) in suspected or known CD. PCC study completion rate of 90%.
Compared with the standard 172°-view capsule, the panoramic 344°-view capsule showed that more patients had a relevant lesion (56.1% vs. 39.0%; p  =  0.023), resulting in higher Lewis scores (222.8 vs. 185.7; p  =  0.031), improving their clinical management (48.8% vs. 31.7%, p  =  0.023)
Eliakim et al., 2020 [10] 41 Prospective, single-centre The study evaluated the development of a novel Pillcam Crohn’s capsule score for the quantification of inflammation in the small bowel and colon in patients with CD There was a high interrater reliability coefficient between the two readers for Lewis inflammatory and PillCamTM Crohn’s score (0.9, p < 0.0001 for both).
The correlation between PillCamTM Crohn’s score and faecal calprotectin was stronger than for Lewis score (r = 0.32 and 0.54, respectively, p = 0.001 for both).
Majter et al., 2021 [11] 38 Prospective, multicentre Detection and classification of CD using PCE using a deep learning framework Deep learning approaches in PCE led to identification of ulcers with sensitivity of 95.4% and specificity of 98.4%. The diagnostic accuracy was 98.5% for the small bowel and 98.1% for the colon
Tai et al., 2021 [16] 93 Multicentre, observational study PCC was used to evaluate the extent and severity of CD. The feasibility, safety, and impact on patient outcomes were also examined. In 85% of cases, the examination was complete, and the PCC resulted in change of clinical management in 38.7% of patients.
The Montreal classification was upstaged in 33.8% of patients with established CD, and mucosal healing was demonstrated in 15.5%. In 12.7% of patients, PCC upstaged the small bowel disease and predicted escalation of treatment.
Volkers et al., 2022 [17] 22 Prospective, multicentre PCE was used to measure changes in mucosal disease activity before and after (8–12 weeks) starting biologic treatment in CD patients. Endoscopic remission (absence of ulcers) was observed in 6 of 22 (27%) patients.
3 of 22 patients (59%) responded endoscopically, (50% decrease in SES-CD and CDEIS scores compared to baseline).
No adverse effects were observed.
Oliva et al., 2020 [18] Prospective, multicentre PCC was used to evaluate the extent and severity of paediatric IBD population. At baseline, active inflammation was seen in 34 patients (71%), in 22 patients (46%) at week 24, and in 18 patients (39%) at week 52.
PCC led to treatment change in 34 patients (71%) at baseline and 11 patients (23%) at 24 weeks.