Total motorized spiral enteroscopy: first prospective clinical feasibility trial.

BACKGROUND AND AIMS: Motorized spiral enteroscopy (MSE) was recently introduced into clinical practice and shown to be safe and effective for antegrade enteroscopy. The aim of the current trial was to prospectively study the efficacy and safety of MSE for visualization of the entire small bowel. METHODS: All consecutive patients with indications for complete enteroscopy meeting the inclusion criteria were enrolled in a prospective observational bicentric trial, starting with antegrade MSE; a retrograde approach was performed if MSE remained incomplete from antegrade. The primary objective was to ascertain the total enteroscopy rate (TER); secondary objectives were diagnostic yield, procedural success, time, depth of maximum insertion (DMI), therapeutic yield, and adverse events (AEs). RESULTS: Thirty patients (16 women, 14 men; median age 64 years [range, 37-100]) were enrolled. Technical success rate of antegrade MSE (advancement beyond the ligament of Treitz) and retrograde MSE (advancement beyond the ileocecal valve [ICV]) were 100% and 100%, respectively. Overall TER was 70%: 16.6% antegrade approach alone and 53.4% bidirectional approach. Median antegrade DMI distal from the ligament of Treitz was 490 cm (range, 160-600); median insertion time 26 minutes (range, 15-110). The median retrograde DMI beyond the ICV was 120 cm (range, 40-600), and median insertion time was 17 minutes (range, 1-68). Overall diagnostic and therapeutic yields were 80% and 86.7%, respectively. Overall AE rate was 16.7%. No serious AEs occurred. CONCLUSIONS: This prospective study showed that complete enteroscopy is feasible with MSE, either from antegrade alone or bidirectionally, with high success rates and short procedural duration. These results justify further evaluation of MSE in a large prospective multicenter study, preferably with inclusion of a control group. (Clinical trial registration number: NCT03438695.).