Novel technique for endoscopic en bloc resection (EMR+) – Evaluation in a porcine model

Abstract

BACKGROUND Endoscopic en bloc resection of larger polyps is relevant because risk of advanced neoplasia or malignancy correlates with tumor size. Recurrence rates after piecemeal endoscopic mucosal resection (EMR) are high and endoscopic submucosal dissection (ESD) is associated with higher complication rates in the western world. AIM To develop a modified endoscopic en bloc resection technique using an external additional working channel and novel agent for submucosal injection. METHODS EMR+ was considered as modified grasp and snare technique. For simultaneous use of a grasping and cutting device a novel additional working channel was used (AWC (R), Ovesco Endoscopy, Tubingen, Germany). AWC (R) is installed on the outer surface of the endoscope, covered with a plastic sleeve and designed for single use. For submucosal injection a new agent consisting of poloxamers was used (LiftUp (R), Ovesco Endoscopy, Tubingen, Germany). The agent is liquid at room temperature and forms a stable and permanent gel cushion after injection. Safety of LiftUp (R) has been shown in a pre-clinical study in domestic pigs. LiftUp (R) is commercially not yet available but approval is expected in early 2019. EMR+ was first developed ex vivo (explanted pig stomach) and subsequently evaluated in vivo (stomach, porcine model, 3 domestic pigs). Main outcome measurements were: Procedure time, macroscopic en bloc resection and adverse events. RESULTS Concept of EMR+ was first developed ex vivo (explanted pig stomach). Ex vivo, 22 resections were performed after technique was established. Median procedure time (measured from begin of injection to extraction of resection specimen) was 7 min (range 5-11, SD 1.68) and median size of resection specimens was 30 mm x 26 mm x 11 mm ex vivo. Subsequently 13 resections were performed in vivo (stomach, porcine model, 3 domestic pigs). In vivo, median procedure time (measured from begin of injection to extraction of resection specimen) was 5 min (range 3-12, SD 2.72) and median size of resection specimens was 35 mm x 35 mm x 11 mm. In vivo, resection was macroscopic complete in 92.3%, major adverse events were not observed. In one case (7.7%) minor periprocedural bleeding was observed and managed by coagulation. CONCLUSION EMR+ appeared to be effective and safe and was easy and fast to perform in the porcine model. EMR+ needs to be further evaluated clinically in comparative trials.