Background & Aims: Double balloon enteroscopy (DBE) was introduced into the US in 2004. Potential complications include perforation, pancreatitis, and gastrointestinal bleeding. Prevalence and risk factors for complications have not been described in a US population. Methods: We conducted a retrospective study of DBE complications in 9 US centers. We obtained detailed information for each complication including patient history, maneuvers performed during the DBE, and presence of altered surgical anatomy. Results: We collected data from 2478 DBE examinations performed from 2004 to 2008. The dataset included 1691 (68%) anterograde DBE, 722 (29%) retrograde DBE (including 5 per-stomal DBEs), and 65 (3%) DBE-facilitated endoscopic retrograde cholangiopancreatography ERCP cases. There were a total of 22 (0.9%) major complications including perforation in 11 (0.4%), pancreatitis in 6 (0.2%), and bleeding in 4 (0.2%) patients. One of 6 cases of pancreatitis occurred post retrograde DBE. Perforations occurred in 3/1691 (0.2%) anterograde examinations and 8/719 (1.1%) retrograde DBEs (P = .004). Eight (73%) perforations occurred during diagnostic DBE examinations. Four of 8 retrograde DBE perforations occurred in patients with prior ileoanal or ileocolonic anastomoses. In the subset of 219 examinations performed in patients with surgically altered anatomy, perforations occurred in 7 (3%), including 1/159 (0.6%) anterograde DBE examinations, 6/60 (10%) retrograde DBEs, and 1 of 5 (20%) peristomal DBE examinations (P < .005 compared with patients without surgically altered anatomy). Conclusions: DBE is associated with a higher complication rate compared with standard endoscopic procedures. The perforation rate was significantly elevated in patients with altered surgical anatomy undergoing diagnostic retrograde DBE examinations.
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