LAUSR

BACKGROUND AND STUDY AIMS Motorized spiral enteroscopy (MSE) has been shown to be safe and effective for deep enteroscopy in studies with limited numbers of patients without previous abdominal surgery at expert centers. Aim of this study was to investigate the safety, efficacy, and learning curve associated with MSE in a real-life scenario with inclusion of patients after abdominal surgery and with altered anatomy. PATIENTS AND METHODS Patients with indications for deep enteroscopy were enrolled in a prospective observational multicenter study. PRIMARY OBJECTIVE serious adverse event rate (SAE); Secondary objectives: diagnostic and therapeutic yield, procedural success, time, insertion depth. Data analysis was subdivided into training and core (post-training) study phases at centers with different levels of MSE experience. RESULTS Two hundred ninety-eight patients (120 females; median age 68 years; 19-92) were enrolled. 21.5% (n=54) had previous abdominal surgery, 10.0% (n=25) had surgically altered anatomy. Overall, SAEs occurred in 2.3% (7/298) 95%CI 0.9%-4.8%. The SAE rate was 2.0% (5/251) in the core group and 4.3% (2/47) in the training group and was not increased after abdominal surgery (1.9%). Total enteroscopy was achieved in half of the patients with planned total enteroscopy (n=42). In 295/337 procedures (87.5%) the anatomical region of interest could be reached. CONCLUSIONS This prospective multicenter study showed that MSE was feasible and safe in a large cohort of patients in a real-life setting after a short learning curve. MSE was shown to be feasible in postsurgical patients and patients with altered anatomy without AE rate increase. NCT03955081 (clinicaltrials.gov).