Background: Balloon-assisted enteroscopy is a useful modality for the evaluation of the small intestinal lesions in patients with Crohn's disease (CD). Not infrequently, deep insertion of the enteroscope carries difficulty due adhesion, stricture, or other causes. Deep insertion is required especially for accurate assessment of mucosal healing and treatment of stricture in CD. The novel device (SIF-Y0006: Olympus Co. LTD., Tokyo) is a single balloon enteroscope, with distal tip diameter of 5.4mm and active/passive bending mechanism. The aim of this study is to investigate improvement of insertion ability with the new device, as compared to the standard single balloon-assisted enteroscope (SBE).
The study protocol was approved by each research ethics committee and registered in the University Hospital Medical Information Network as UMIN00017835.
Methods: The patients with CD in whom insertion difficulty existed in the past or expected due to adhesion or stricture are recruited for this study. The standard SBE (SIF-Q260) was inserted per rectally for usual clinical indication. All procedures were performed by expert endoscopists with sufficient experience with enteroscopy. The length of small intestinal insertion less than 1m was regarded as insertion failure, and the scope was removed after crystal violet making at the deepest portion. Then SIF-Y0006 was re-inserted by the same expert endoscopist. Insertion time to the marking, length of small intestinal insertion, accomplishment of procedure objectives, and patient's acceptance were assessed.
Results: Thirty eight patients were enrolled for this study. Nine patients in whom the length of small intestinal insertion was more than 1 m with the standard SBE were excluded, and remaining 29 patients (CD 25, suspicious of CD 4) were included. With SIF-Y0006, the scope was inserted to the marking in all cases, and beyond the marking in 26. The small intestinal insertion length (24±19 vs. 44±27 cm) and the insertion time to the marking (12±7.5 vs. 5.5±5.6 min) with Y0006 were significantly superior to those with Q-260. Procedure objectives were attained in 81% with Y0006. The patient's acceptance was also better with Y0006.
Conclusions: The new prototype small-caliber enteroscope is useful in patient with CD in whom small intestinal insertion is difficult.