Natural orifice versus conventional laparoscopic distal pancreatectomy in a porcine model: a randomized, controlled trial
Received 6 March 2008; accepted 11 March 2009. published online 29 June 2009.
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.
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.
Current affiliations: Department of Medicine, Gastrointestinal Unit (F.F.W., W.R.B.), Department of Surgery (D.W.G., P.S., D.W.R.), Department of Radiology (A.K., A.H.S., D.S.), Department of Pathology (M.M.-K.), Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
Reprint requests: William R. Brugge, MD, 55 Fruit Street, Blake 4, Boston, MA 02114.
DISCLOSURE: This study was supported by an American Society for Gastrointestinal Endoscopy 2007 Research and Outcomes and Effectiveness Award (F. F. Willingham, D. W. Gee, D. W. Rattner, W. R. Brugge). All other authors disclosed no financial relationships relevant to this publication.
Presented at the American Society for Gastrointestinal Endoscopy 12th Annual Video Forum and at the American Society for Gastrointestinal Endoscopy Plenary Session, Digestive Disease Week, May 21, 2008, San Diego, California.
If you would like to chat with an author of this article, you may contact him at Wbrugge@partners.org.
ABSTRACT
Natural orifice versus conventional laparoscopic distal pancreatectomy in a porcine model: a randomized, controlled trial