Natural orifice versus conventional laparoscopic distal pancreatectomy in a porcine model: a randomized, controlled trial

Background: Natural orifice transluminal endoscopic surgery (NOTES) research has primarily involved case series reports of low-risk procedures. Distal pancreatectomy has significant postoperative morbidity and would permit rigorous examination in a controlled trial setting. Objective: To compare endoscopic transgastric distal pancreatectomy (ETDP) and laparoscopic distal pancreatectomy (LDP). Design: Prospective, randomized, controlled trial. Setting: Academic hospital. Subjects: Forty-one swine, 28 block randomized. Interventions: LDP was performed with 3 trocars and stapled transection of the pancreas. ETDP was performed via a gastrotomy, with 1 trocar for visualization, by using endoloop placement, snare transection, and purse-string gastrotomy closure. Main Outcome Measurements: Clinical examination, CT, serum chemistries, necropsy, peritoneal fluid analysis, and histologic examination. Results: Swine were survived for 8 days. The procedure time for ETDP was significantly greater than for LDP (1:52 vs 0:33 [hours:minutes]; P = .00). Pancreatic specimen weight was similar (4.1 g vs 5.5 g; P = .108). Postoperatively, 26 of 28 animals thrived. In the LDP group, 1 death caused by pancreatic leak and renal failure occurred on day 1. In the ETDP group, 1 death caused by pneumothorax occurred intraoperatively. The necropsy, CT, and histologic examinations revealed focal resection-margin necrosis in 3 to 7 swine in the ETDP group with no proximal necrosis or pancreatitis. The groups were equivalent clinically, by survival, and by serum and peritoneal fluid analysis. The gastrotomy closure was associated with small serosal adhesions, but no gross abscess or necrosis. Limitation: Animal study. Conclusions: In the largest controlled trial of NOTES orifice surgery to date, there was no clinical or survival difference between NOTES and laparoscopic approaches.