Non-exposure simple suturing endoscopic full-thickness resection (NESS-EFTR) versus laparoscopic wedge resection: a randomized controlled trial in a porcine model.

BACKGROUND: Current endoscopic full-thickness resection (EFTR) methods produce transmural communication and expose the tumor to the peritoneum. An EFTR method with a simple suturing technique that does not expose the gastric mucosa to the peritoneum (non-exposure simple suturing, NESS) was recently developed. To date, there have been no prospective studies that compare EFTR with laparoscopic wedge resection in human or animal. The aim of this study was to compare outcomes between NESS-EFTR and laparoscopic wedge resection (LWR) using the linear staplers in a randomized animal study.
METHODS: NESS-EFTR includes steps of laparoscopic seromuscular suturing, EFTR of the inverted stomach wall, and endoscopic mucosal suturing with endoloops and clips. Sixteen pigs underwent NESS-EFTR (n = 8) or LWR (n = 8). The resected locations were the cardia, fundus, upper body anterior and greater curvature, antrum lesser and greater curvature side. The pigs were killed 3 weeks after surgery. Rates of successful complete resection (en-bloc resection with clear margins), successful closure, and complications were evaluated.
RESULTS: The complete resection rates in the NESS-EFTR and LWR groups were 100 and 75%, respectively (P = 0.467). All wounds were successfully closed in both groups. Resected tissues were significantly larger in the LWR group (mean ± SD: 8.0 ± 0.8 cm vs. 4.4 ± 0.5 cm, P < 0.001). Procedure time was significantly shorter in the LWR group (31.7 ± 10.0 min vs. 118.1 ± 23.4 min, P < 0.001). Early deaths due to complications only occurred in the LWR group (a leakage at cardia and a stenosis at the antrum lesser curvature side).
CONCLUSIONS: Incomplete resection and complications were occurred in only LWR group. NESS-EFTR was feasible and safe in animal.

RCT Entities:   Population Interventions Outcomes