Intest Res.  2020 Apr;18(2):229-237. 10.5217/ir.2019.09150.

Prototype single-balloon enteroscopy with passive bending and high force transmission improves depth of insertion in the small intestine

• Morita Y
• Bamba S
• Inatomi O
• Takahashi
• Imai T
• Murata M
• Ohno M
• Sasaki M
• Tsujikawa
• Andoh A

• KMID: 2501388
• DOI: http://doi.org/10.5217/ir.2019.09150

Abstract

Background/Aims
We retrospectively analyzed Crohn’s disease (CD) patients with small intestinal strictures who underwent single-balloon enteroscopy (SBE) to ascertain whether prototype SBEs with a passive bending mechanism and high force transmission insertion tube had better insertability in the small intestine than a conventional SBE.
Methods
Among 253 CD patients who underwent SBE, we identified 94 CD patients who had undergone attempted endoscopic balloon dilatation (EBD) for small intestinal stenosis for inclusion in this study. We analyzed whether the type of scope used for their initial procedure affected the cumulative surgery-free rate. For the insertability analysis, patients who underwent SBE at least twice were divided into 3 groups according to the type of scope used: conventional SBE only, prototype SBE only, and both conventional and prototype SBEs. For each group, depth of insertion, procedure time, and number of EBDs were compared in the same patient at different time points.
Results
The success rate of EBD was 88.3%. The 5- and 10-year cumulative surgery-free rate was 75.7% and 72.8%, respectively. Cox regression analysis indicated that the factors contributing to surgery were long stricture (≥2 cm), EBD failure, and elevated Crohn’s Disease Activity Index, but not the type of scope used for EBD. The prototype SBEs significantly improved the depth of insertion (P=0.03, Wilcoxon’s signed-rank test).
Conclusions
In CD patients with small intestinal stenosis, the prototype SBEs with a passive bending mechanism and high force transmission insertion tube did not improve long-term EBD outcome but did improve deep insertability. (Clinical Trial Registration No. UMIN000037102)

Keyword

Balloon-assisted enteroscopy; Dilation; Double-balloon enteroscopy

Figure

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  Fig. 1. Study participants. Among 253 CD patients who underwent single-balloon enteroscopy (SBE), 94 underwent attempted endoscopic balloon dilatation (EBD) for small intestinal stenosis. The clinical characteristics of these 94 patients are shown in Table 1. To compare the insertability, patients who underwent SBE at least twice during the observation period were extracted and divided into 3 groups: conventional SBE only, prototype SBE only, and both conventional and prototype SBEs. Detailed information of these groups is shown in Table 3.

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  Fig. 2. Cumulative surgery-free survival rate. Kaplan-Meier curves depicting cumulative surgery-free survival for all patients (A), and stratified by CDAI (B), stricture length (C), and endoscopic balloon dilatation (EBD) success (D). P-values for each curve were calculated using the log-rank test.

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  Fig. 3. Insertability and scope used. Patients who underwent single-balloon enteroscopy (SBE) at least twice during the observation period were extracted and divided into 3 groups according to the scope used: (A, D, G) conventional SBE only; (B, E, H) prototype SBE only; and (C, F, I) both conventional and prototype SBEs. For comparison of deep insertability into the small intestine, the 2 most recent procedures were compared in the conventional SBE only group and the prototype SBE only group. The most recent switching opportunity was compared in the group that underwent both conventional and prototype SBE. For each group, depth of insertion (A-C), procedure time (D-F), and number of endoscopic balloon dilatations (G-I) were compared using Wilcoxon’s signed-rank test.

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  Fig. 4. Representative case. X-ray images at the time of endoscopic balloon dilatation (EBD) at different time points in the same patient. Depth of insertion and the number of EBDs were increased when using single-balloon enteroscopy (SBE) with a passive bending mechanism and high force transmission insertion tube. (A) Conventional SBE: depth of insertion (70 cm) and number of EBDs (n=2). (B) Prototype SBE: depth of insertion (120 cm) and number of EBDs (n=8).

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