First endoluminal system for transmural resection of colorectal tissue with a prototype full-thickness resection device in a porcine model

Abstract

Background: Endoluminal transmural resection of colorectal lesions is a pivotal advance in endoscopic technology. A full-thickness resection device has been developed that functions through a combination of tissue grasping, stapling, and cutting under endoscopic guidance. This preclinical study evaluated the performance, safety, and effectiveness of the full-thickness resection device in a porcine model. Methods: The full-thickness resection device consists of an operative handle, flexible shaft, and a resection chamber head. Eight pigs were randomized to 2 survival groups (4 each) of 14 and 28 days. The mucosa was marked electrosurgically to delineate target areas in the distal colon. A gastroscope inserted through the channel of the full-thickness resection device was advanced together with the device to the target. Targeted tissue was pulled into the resection chamber with a forceps, staples were deployed, and the isolated specimen was resected with a cutting blade. Histologic and radiographic evaluations were performed. Results: All resections were transmural. Mean resected tissue diameter was 3.6 cm (1.4-5.2 cm). Mean procedure time was 30.2 (15) minutes. Minor mechanical problems required the use of replacement devices to complete 3 procedures. Resection sites were identified endoscopically and radiographically at sacrifice. In one animal, local adhesions were present. Histology evaluation disclosed resection line mucosal ulceration in 4 animals with fibroinflammatory changes consistent with healing. Conclusions: The full-thickness resection device can be used for endoluminal transmural localized resection of colorectal tissue in an animal model.