A randomized, controlled trial (RCT), comparing the total enteroscopy rate and efficacy of the Novel Motorized Spiral Enteroscopy (NMSE) versus the Single Balloon Enteroscopy (SBE) – THE MOTOR TRIAL (NCT 05548140)

Aims Novel Motorized Spiral Enteroscopy (NMSE) has been found to be safe and effective for small bowel evaluation [1]. We have aimed to compare NMSE with the standard of care, Single Balloon Enteroscopy (SBE).

Methods Patients with small bowel diseases, requiring enteroscopy were randomized into 2 groups either NMSE or SBE between September to November 2022 at a tertiary care centre. The primary objective was the total enteroscopy rate (TER). The secondary objectives were to compare the technical success, diagnostic yield, therapeutic success, and adverse events ([Table 1]).

Table 1 Procedure details and Outcomes.

Results Among the 110 patients assessed for enteroscopy,72 patients were randomized into 2 groups, NMSE(n=35) and SBE(n=37). After exclusions, NMSE(n=28) and SBE(n=27) were analyzed. The predominant indications were Obscure GI bleeding (48%), Unexplained abdominal pain with indeterminate imaging (31%) and chronic diarrhoea (20%). The TER was statistically significant [NMSE vs SBE, 71.4% vs 10.8% (ITT); 89.2% vs 14.8% (per-protocol),p<0.0001] with a significant difference in the total procedure time [NMSE vs SBE, (mean, min) – 58.17 vs 114.2 (ITT); 62.4 vs 126.2 (per-protocol),p<0.0001]. The diagnostic yield and therapeutic success were not statistically different, with no major adverse events. The major diagnostic findings were ‘Inflammatory lesions’ by both modalities.

Conclusions NMSE should be considered as a non-surgical gold standard procedure for deep small bowel evaluation due to high TER rate, short procedure time and no major adverse events.

Publikationsverlauf

Artikel online veröffentlicht:
14. April 2023

• 1 Ramchandani M, Rughwani H, Reddy DN.. Diagnostic yield and therapeutic impact of novel motorized spiral enteroscopy in small-bowel disorders: a single-center, real-world experience from a tertiary care hospital (with video). Gastrointestinal Endoscopy 2021; 93 (03) 616-26