Impact of fluoroscopy on oral double-balloon enteroscopy: results of a randomized trial in 156 patients.

ABSTRACT

BACKGROUND AND STUDY AIMS: The routine utility of fluoroscopy during double-balloon enteroscopy (DBE) via the oral route has been not prospectively evaluated. Up to now, there have been no prospective randomized trials to assess whether fluoroscopy improves outcomes. The aim of this study was to assess the value of fluoroscopy during oral DBE. PATIENTS AND METHODS: A total of 156 patients (88 men, 56.4 %) of mean (standard deviation [SD]) age 56 (19) years were randomly assigned to undergo oral DBE either with or without fluoroscopy. The majority of the patients had obscure gastrointestinal bleeding (n = 96, 62 %). The primary target criteria for the study were postpyloric insertion depth and time required to reach the deepest insertion point. A secondary target criterion was the diagnostic yield achieved. RESULTS: The results in the fluoroscopy and nonfluoroscopy groups did not differ significantly with respect to the mean (SD) insertion depth (fluoroscopy, 284 [89] cm, range 70 - 470 cm; nonfluoroscopy, 256 [86] cm, 40 - 430 cm), the mean time required to reach the deepest point of insertion, or the diagnostic yield achieved. In patients with previous abdominal surgery and during difficult procedures, the mean insertion depth was significantly lower. CONCLUSIONS: Fluoroscopy during DBE via the oral route does not provide a significant gain in insertion depth, advancement time, or diagnostic yield in comparison with nonfluoroscopically guided procedures. In experienced hands, fluoroscopy does not have to be used routinely during oral DBE.