Transvaginal cholecystectomy by using a prototype flexible clip applier.
BACKGROUND
Currently, no endoscopic clips have been proven to be effective in ligating the cystic duct in natural orifice transluminal endoscopic surgery (NOTES) hybrid cholecystectomy.


OBJECTIVE
To determine the safety and feasibility of a prototype endoscopic flexible clip applier, which is the only flexible device that deploys a zero-gap clip.


METHODS
Pilot study in a survival porcine model. Necropsy was performed at 2 weeks postprocedure.


METHODS
University of Missouri animal laboratory, Columbia, Missouri.


METHODS
Transvaginal cholecystectomy was performed on 6 survival pigs using the NOTES Toolbox 1.0.


METHODS
Safety and feasibility of the described instrument. Investigators were asked to fill out a standardized, blinded questionnaire on the ease of use and functionality of the flexible clip applier.


RESULTS
Clipping of the cystic duct was achieved with the flexible clip applier in all 6 pigs. The mean time for completion of clipping of the cystic duct was 9 minutes. Multiple attempts were required to successfully fire the clip in 2 of 6 pigs. We were unable to visualize the tip of the clip before deployment. Difficulty releasing the clip from the applier once fired and challenges in clip loading were encountered. The clips were visualized in place at necropsy, with no bile leakage, evidence of infection, or injury to surrounding structures seen in any cases.


CONCLUSIONS
Preclinical animal model.


CONCLUSIONS
The prototype flexible clip applier showed adequate safety and was feasible in clipping the cystic duct in all animals. Design efforts to improve clip visualization, loading, and release are underway.
Whang
Susan H
SH
Department of General Surgery, University of Missouri, Columbia, Missouri 65212, USA.
Satgunam
Shean
S
Miedema
Brent W
BW
Thaler
Klaus
K
D000818:Animals; D001652:Bile Ducts / Q000601:surgery*; D002763:Cholecystectomy / Q000379:methods*; D004195:Disease Models, Animal; D019723:Endoscopes; D016145:Endoscopy, Digestive System / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D008026:Ligation / Q000295:instrumentation; D010865:Pilot Projects; D013537:Sutures; D013552:Swine; D014621:Vagina; D014741:Video Recording