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.

DESIGN

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

SETTING

University of Missouri animal laboratory, Columbia, Missouri.

INTERVENTION

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

MAIN OUTCOME MEASUREMENTS

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.

LIMITATIONS

Preclinical animal model.

CONCLUSION

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.