Safe and Rapid Intubation of the Distal Small Bowel Using the Discovery SB™ Overtube Device During Small Bowel Enteroscopy

Abstract

Purpose: Indications for small bowel (SB) enteroscopy are increasing, but advancing the endoscope to distal small intestine remains challenging. The Discovery SB™ device (Spirus Medical, Stoughton, MA), a novel spiral-shaped overtube FDA-approved for SB enteroscopy, may allow for simple & quick intubation of the ileum comparable to current methods. Aim: to evaluate ease-of-use, safety, and efficacy of Discovery SB™ during SB enteroscopy. Methods: 33 endoscopists without prior Discovery SB™ experience from 19 academic centers & 2 instructors performed SB enteroscopy in human patients as clinically indicated during 1 of 4, 2-day training modules. All procedures performed w/o endotracheal intubation. Data were collected prospectively. Patient demographics, indication, depth and time to maximal insertion, total procedure time & findings were recorded. Any trauma was documented during scope withdrawal and scored 0–5 (0 = no trauma, 1 = edema/erythema, 2 = superficial hematoma/erosion, 3 = superficial laceration, 4 = deep laceration, 5 = perforation). Overall means were calculated; Day 1 and Day 2 results were compared. Data were analyzed using 2-tailed t-test, or rank-sum test for non-normally distributed data. Results: 90 procedures were successfully performed in 95 patients (72.6% women, mean age = 48.8 ± 14.2 yrs). Most common indication was chronic abdominal pain. Mean BMI was 28.4 ± 17.2 with median Mallampati (M)–airway assessment–score = 2 (range = 1–4). Endoscopists performed a mean of 5 cases. Mean time required for device to engage SB was 10 ± 5.5 min, with mean time to maximal scope insertion of 20.9 ± 6.4 min. Mean depth achieved was 262 ± 57.4 cm beyond ligament of Treitz. Total procedure time was 33.6 ± 8.0 min. In 83.9%, 89.3% & 78.5% of patients, trauma score≤2 was recorded in esophagus, stomach & intestine, respectively. There were no perforations. Trauma score > 2 was documented in 3/5 of patients with M-score = 4, vs. 4/28 with M-score = 1 (P= 0.075). No statistically significant associations between trauma score and the following: age, BMI, time to SB engagement, depth of insertion, time to maximal insertion, total procedure time, or Day 1 vs. Day 2 procedures. Depth of insertion was significantly greater among endoscopists on Day 2 vs. Day 1 (276.9 ± 53.7 vs. 252 ± 58 cm, respectively; P= 0.043). In 88.9% of cases, endoscopists rated the quality of withdrawal and position/control in the intestine ≥4 (scale of 1–5; 5 = excellent, 1 = poorest). Conclusion: The Discovery SB™ allows for safe & easy advancement of the enteroscope into the distal small bowel. Maximum depth of insertion utilizing spiral enteroscopy is comparable to balloon enteroscopy while taking less time. The device is easy to use and provides deep penetration of the small intestine in as few as 5 training cases.