The feasibility and safety of disposable endoscope vs. conventional endoscope for upper gastrointestinal tract examination: a multicenter, randomized, parallel, non-inferiority trial

Background A disposable upper gastrointestinal endoscope can effectively decrease infectious outbreaks associated with endoscope reuse. In the present study, we aimed to evaluate the feasibility and safety of a disposable endoscope for upper gastrointestinal examination. Methods In a prospective, randomized trial, 144 upper endoscopic procedures were allocated to either the disposable endoscope group or the conventional endoscope group. The primary outcomes were rates of excellent and good image qualities and maneuverability satisfaction. The second outcome included procedure duration, endoscopic diagnosis, and adverse events. Results A total of 144 subjects were enrolled in the present analysis and prospectively randomized to 2 study groups. Finally, 70 and 69 subjects were enrolled in the novel disposable endoscope group and the conventional endoscope group, respectively, due to the schedule cancellation of 5 subjects. The baseline characteristics of the patients were similar in both groups. The excellent and good image quality rates and maneuverability satisfaction of the novel disposable endoscope were not inferior to the conventional endoscope (p = 0.99 and p = 0.99, respectively). Moreover, no significant between-group difference was observed in the endoscopic results and adverse events (p = 0.30 and p = 1, respectively). However, the procedure duration in the novel disposable endoscope was longer compared with the conventional endoscope (8.40 ± 4.28 min vs. 5.12 ± 2.65 min, p < 0.001). Conclusions The novel disposable endoscope was as safe, effective, and maneuverable as a conventional endoscope. However, the novel disposable endoscope was associated with a longer procedure duration.

One-stop shop for variceal surveillance: integration of unsedated ultrathin endoscopy into the routine clinic visit

BackgroundThe endoscopic appearance of oesophageal varices determines the need for prophylaxis. However, as the point prevalence of varices is low (25%), the majority of surveillance endoscopies are unnecessary and costly. Narrow diameter,ultrathin (UT) endoscopes are more tolerable than conventional upper gastrointestinal (UGI) endoscopes and can be used without sedation. We hypothesised that unsedated UT endoscopy for variceal surveillance could be implemented during the routine outpatient clinic visit allowing accurate diagnosis of varices and the timely provision of prophylaxis.MethodsPatients with cirrhosis awaiting surveillance endoscopy were identified. UT endoscopy was scheduled during routine clinic review at the same time as ultrasound surveillance for hepatocellular carcinoma. UGI endoscopy was performed unsedated using the E.G Scan II disposable endoscope. Varices were graded using the modified Paquet classification. Video recordings of procedures were reviewed by blinded assessors and agreement was assessed using the kappa statistic.Results40 patients (80% male) underwent unsedated UT endoscopy. All procedures were successful and tolerated well in 98% of cases. Median procedure time was 2 min (IQR 1–3). Varices were found in 37.5% (17.5% grade 1 and 20% grade 2). Patients with grade 2 varices were prescribed non-selective beta blockers at the clinic appointment. Kappa statistic for the finding of any varices was 0.636 (p=0.001) and 0.8–1.0 for diagnosis of grade 2 varices (p<0.0001).ConclusionsOutpatient unsedated ultrathin endoscopy in patients with cirrhosis is accurate, safe and feasible. This integrative care model is convenient, particularly for regional communities, and is likely to result in significant cost savings associated with variceal surveillance.

Evaluation of a novel low-cost disposable endoscope for visual assessment of the esophagus and stomach in an ex-vivo phantom model

Background and study aims Our academic lab has developed a novel, low-cost, disposable endoscope for assessment of the esophagus and stomach without need for large equipment or complex electronics. Usability and intuitiveness of the platform are unknown. Methods The novel endoscope (NE) consists of a high-definition camera, LED module, and three bellows. Compressed air actuates the bellows, producing camera/LED articulation. Insufflation and lens cleaning ports are present. Video can be displayed on any monitor. Total material costs less than $ 35 US. Five novices, five fellows, and five attendings performed five trials using a conventional endoscope and the NE on an upper tract phantom with six gastric landmarks marked. Outcomes included successful identification and time to landmarks; and intuitiveness (NASA task load index; user comments). Results All landmarks were successfully identified with both endoscopes for all trials (n = 900). Attendings and fellows were quicker with the conventional endoscope when compared to the NE (24.48 v 37.13s; P < 0.01). There was no significant time difference between platforms for novices (P = 0.16). All users found the NE intuitive with low mental and physical demand. Novices reported lower temporal demand and effort when using the NE. Conclusions The NE was easy to maneuver, intuitive, and successful at visualizing gastric landmarks. All users were pleased with the NE drive mechanism and were successful at visualizing the gastric landmarks in a clinically acceptable time. The novel platform has the potential to facilitate rapid, low-cost, diagnostic assessment of the esophagus and stomach in non-traditional settings – facilitating patient management decisions, minimizing encumbrance, and avoiding cross-contamination.