Patients
A total of 22 patients were enrolled and underwent DBE using an oral approach. Small bowel obstruction was suspected in one patient, and patency was not confirmed by PC in another patient. Finally, 20 patients underwent PCCE-2 and subsequent DBE using an anal approach. Table 2 shows the characteristics of the 20 patients.
Results of the PCCE-2 procedure and number of segments evaluated by both modalities
The PCCE-2 excretion rate within the battery life was 75% (15/20). Of the five patients who did not excrete the PCCE-2, two were observed up to the left colon, one was observed up to the transverse colon, and two were observed up to the right colon. Of the 15 patients who excreted the PCCE-2, the median duration of the entire examination was 484 min, the gastric transit time was 80 min, the small intestinal transit time was 69 min, and the colorectal transit time was 265 min. The colon cleansing level was evaluated as adequate in 80% of the patients.
Of the 20 patients, 20 gastric, 60 small bowel, and 64 large bowel segments were evaluated. As for large bowel segments, 16 segments were excluded because PCCE-2 could not be observed or evaluated in postoperative cases.
Positive findings of PCCE-2 in the whole GI tract
Various lesions, including ulcer scars, erosion, ulcers, bamboo joint-like appearance, and notch-like appearance, were detected in the whole GI tract of patients with CD by PCCE-2. Among them, ulcer scars, erosion, and ulcers were frequently observed in the small and large bowel, and erosion and bamboo joint-like appearance were most commonly observed in the stomach. The detection rates of PCCE-2 for ulcer scars, erosion, and ulcers per segment were 52%, 43.3%, and 10% in the small bowel, and 20%, 38%, and 28%, respectively, in the large bowel. The detection rates for erosion and bamboo joint-like appearance in the stomach were 35% and 10%, respectively.
Diagnostic yield of PCCE-2
The diagnostic yield of PCCE-2 for the small and large bowel is shown in Table 3. The PCCE-2 sensitivities for ulcer scars, erosion, and ulcers were 83.3%, 93.8%, and 88.5%, respectively, and the specificities were 76.0%, 78.3%, and 81.6%, respectively.
The diagnostic yield of PCCE-2 for the small bowel is shown in Table 4. Sensitivities and specificities for active CD lesions, such as erosion and ulcers, were more than 85%. No significant difference was found in the sensitivities and specificities between the three segments of the small bowel (Table 5).
Table 6 shows the diagnostic yield of PCCE-2 for the large bowel. The sensitivities were satisfactory, but the specificities for erosion and ulcers were relatively low compared with those of the small bowel. No significant difference was observed between the four segments of the large bowel, as was found for the small bowel (Table 7).
For gastric lesions, erosion and bamboo joint-like appearance were detected. Supplementary Table 1 shows the diagnostic yield of these gastric lesions. No esophageal lesions were noted in any of the patients.
Incidence and severity of PCCE-2 procedure-related adverse events
PCCE-2 retention was not observed in patients with CD in whom patency was confirmed by PC. Of the 20 patients, one patient had moderate and three had mild abdominal bloating, two had mild abdominal pain, and two had mild nausea during PCCE-2 examination. Eighteen of the 20 patients indicated that they would undergo PCCE-2 again, and they preferred PCCE-2 to CS and DBE.