Hybrid NOTES transgastric cholecystectomy with reliable gastric closure: an animal survival study.
BACKGROUND
Secure transluminal closure remains the most fundamental barrier to safe translation of transgastric natural orifice transluminal endoscopic surgery (NOTES) procedures to humans. Obtaining optimal critical view of safety (CVS) is a prerequisite to performing cholecystectomy avoiding common bile duct injury.


OBJECTIVE
(1) To evaluate feasibility and safety of hybrid transgastric NOTES cholecystectomy. (2) To evaluate feasibility and reliability of gastrotomy closure using a novel Over-The-Scope-Clip (OTSC; Ovesco) in survival porcine experiments.


METHODS
Laparoscopic access to the abdominal cavity was obtained by two 2-mm and one umbilical optical trocar(s). Gastric access was created by balloon dilatation of a needle knife puncture up to 18 mm. Exposure of CVS was obtained and evaluated by aid of a 2-mm device. Subsequently the cystic duct and artery were clipped endoscopically. After laparoscopic dissection the specimen was extracted via the stomach. The gastrotomy was closed endoscopically using the OTSC. Necropsy was performed after 10 days with inspection of gastrotomy and peritoneal cavity for complications. Experiments were planned in 3 acute and 16 survival pigs. Main outcome parameters were documented exposure of CVS, successful cholecystectomy and closure, uncomplicated survival and histology-confirmed full-thickness closure.


RESULTS
In all 16 survival experiments CVS was obtained satisfactorily and hybrid cholecystectomy was successfully performed [100%; 95% confidence interval (CI): 81-100%]. Transgastric closure was endoscopically successful in all experiments in mean time of 7 min [standard deviation (SD) 3 min]. At necropsy 10 days after surgery there were no signs of (infectious) complications. Histology confirmed full-thickness healing with 100% success (95% CI: 81-100%).


CONCLUSIONS
Hybrid transgastric NOTES cholecystectomy is feasible, safe and results in optimal CVS. Use of OTSC for gastrotomy closure is feasible, reliable and results in histology-proven full-thickness closure in survival porcine experiments.
Voermans
Rogier P
RP
Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
van Berge Henegouwen
Mark I
MI
Bemelman
Willem A
WA
Fockens
Paul
P
D057868:Anastomotic Leak / Q000517:prevention & control*; D000818:Animals; D002404:Catheterization; D017081:Cholecystectomy, Laparoscopic / Q000379:methods*; D003549:Cystic Duct / Q000601:surgery; D005240:Feasibility Studies; D005260:Female; D005773:Gastroscopy / Q000379:methods*; D057605:Natural Orifice Endoscopic Surgery / Q000379:methods*; D010529:Peritoneal Cavity / Q000473:pathology; D013270:Stomach / Q000473:pathology / Q000601:surgery*; D034421:Sus scrofa; D013552:Swine; D016896:Treatment Outcome