A Randomized, Controlled Trial, comparing the Total Enteroscopy Rate and Diagnostic Efficacy of Novel Motorized Spiral Enteroscopy and Single Balloon Enteroscopy in patients with Small-Bowel Disorders - THE MOTOR TRIAL (NCT 05548140).

Abstract

Device-assisted enteroscopy (DAE) has revolutionized the management of Small Bowel Disorders (SBD). No study to date has compared both Novel Motorized Spiral Enteroscopy (NMSE) and Single Balloon Enteroscopy (SBE) as a randomized controlled trial. Hence, this study was planned to include patients having SBD with the primary aim to compare the Total Enteroscopy Rate (TER). This study was conducted at the Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India from 20th September 2022 to 15th December 2022. All consecutive patients, aged more than 18 years with suspected SBD, and planned for Total Enteroscopy (TE) were screened for inclusion. The primary outcome was to compare the TER and secondary outcomes were to compare the technical success, time taken to reach the Depth of Maximal Insertion (DMI), withdrawal time, total procedure time, diagnostic yield, therapeutic success, and adverse events. Seventy-two patients out of the 110 patients screened, were randomized in either of NMSE (n=35) or SBE (n=37) group. The most common indication for the procedures was obscure GI bleed (48%), others being unexplained abdominal pain with indeterminate radiologic findings (32%) and chronic diarrhea (20%). In NMSE group the TER was 71.4%; while in the SBE group, it was 10.8%, (p<0.0001). The total procedure time (min) was much lesser with NMSE (58.17±21.5 min) versus SBE (114.2±33.5 min), (p<0.0001). The diagnostic yield of NMSE (80%) was comparatively higher than SBE (62.1%), (p = 0.096). Minor adverse events (Grade I) were observed in both the groups: NMSE (3/35, 8.5%) and SBE (2/37, 5.4%). This RCT shows that with NMSE higher TER can be achieved in shorter duration with minimal adverse events, compared to SBE.