Novel modified endoscopic mucosal resection of large GI lesions (> 20 mm) using an external additional working channel (AWC) may improve R0 resection rate: initial clinical experience.

BACKGROUND: En-bloc resection of large, flat dysplastic mucosal lesions of the luminal GI tract can be challenging. In order to improve the efficacy of resection for lesions ≥2 cm and to optimize R0 resection rates of lesions suspected of harboring high-grade dysplasia or early adenocarcinoma, a novel grasp and snare EMR technique utilizing a novel over the scope additional accessory channel, termed EMR Plus (EMR+), was developed. The aim of this pilot study is to describe the early safety and efficacy data from the first in human clinical cases. METHODS: A novel external over-the-scope additional working channel (AWC) (Ovesco, Tuebingen, Germany) was utilized for the EMR+ procedure, allowing a second endoscopic device to be used through the AWC while using otherwise standard endoscopic equipment. The EMR+ technique allows tissue retraction and a degree of triangulation during endoscopic resection. We performed EMR+ procedure in 6 patients between 02/2018-12/2018 for lesions in the upper and lower GI tract. RESULTS: The EMR+ technique utilizing the AWC was performed successfully in 6 resection procedures of the upper and/or lower GI tract in 6 patients in 2 endoscopy centers. All resections were performed successfully with the EMR+ technique, all achieving an R0 resection. No severe adverse events occurred in any of the procedures. CONCLUSIONS: The EMR+ technique, utilizing an additional working channel, had an acceptable safety and efficacy profile in this preliminary study demonstrating it's first use in humans. This technique may allow an additional option to providers to remove complex, large mucosal-based lesions in the GI tract using standard endoscopic equipment and a novel AWC device.

Learning curve for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic lesions in a novel ex-vivo simulation model.

Background: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is essential in the management of digestive cancers. However, teaching and learning this technique remain challenging due to the lack of cost-effective models. Material and methods: This was a prospective experimental study using a complete porcine upper gastrointestinal ex-vivo organ package, placed in an Erlangen Active Simulator for Interventional Endoscopy (EASIE-R), and prepared with one cyst and two solid masses (2 cm). Five fellows inexperienced in EUS-FNA were enrolled, performing 10 procedures on each lesion, alternatively. The total time, number of attempts for success, of needle view losses, and of scope handling were recorded, associated with an independent skills rating by procedure. We compared the first 15 procedures with the last 15 for each fellow. Results: The fellows successfully performed all procedures in 2 to 40 minutes, requiring 1 to 6 attempts. All (5/5) improved their total time taken (P < 0.001), number of times when the EUS view of the needle was lost (P < 0.05), scope handling (P < 0.005), and skills rating (P < 0.001), whereas 4/5 (80 %) improved their number of attempts. The overall evaluation showed a significant decrease (P < 0.001) in the total time taken (11.2 ±â€Š7.8 vs 4.3 ±â€Š2.2 minutes), number of attempts (2.6 ±â€Š1.2 vs 1.2 ±â€Š0.7), number of times when the EUS view of the needle was lost (2.3 ±â€Š2 vs 0.5 ±â€Š0.7), and need for scope handling (1.1 ±â€Š1.7 vs 0.1 ±â€Š0.2). We also observed an improvement in skills rating (5 ±â€Š1.9 vs. 7.7 ±â€Š1.1). Conclusion: This newly designed ex-vivo model seems to be an effective way to improve the initial learning of EUS-FNA, by performing 30 procedures.