Prospective, randomized, single-center trial comparing double-balloon enteroscopy and spiral enteroscopy in patients with suspected small-bowel disorders

Background Double-balloon enteroscopy (DBE) is an established method in diagnostic and therapeutic small-bowel enteroscopy. Objective Spiral enteroscopy (SE) appears to be a promising new technique. A randomized, prospective study was conducted to compare both methods. Design Randomized, prospective study. Setting Single tertiary referral center. Patients Between September 2009 and March 2011, 26 patients with suspected mid-GI disorders completed the study. Interventions Patients were randomly assigned to DBE or SE. The oral examination was conducted first, with the deepest point reached being marked with India ink. An additional anal examination followed the day after, with the aim of reaching the ink mark. Main Outcome Measurements The primary endpoint of the study was the rate of complete enteroscopies achieved. Results The rate of complete enteroscopies with DBE was 12 times the rate achieved with SE (8% in the SE group and 92% in the DBE group; P = .002). With regard to the secondary study criteria, much longer examination times but greater depths of insertion were associated with DBE. There were no statistically significant differences in the diagnostic or therapeutic outcomes between the SE and DBE groups (diagnostic yield, P = .428; therapeutic yield, P = 1.0; Fisher exact test). One perforation occurred during an anal examination as a relevant adverse event in SE. Limitations Single-center study, small sample size. Conclusion SE does not represent an alternative to DBE with regard to the depth of insertion or the rate of complete enteroscopies achieved. However, SE is advantageous in that it involves significantly shorter examination times. Further technical improvements will be necessary before SE can compete with DBE for complete enteroscopies.