Randomized comparative trial of a novel one-step needle sphincterotome versus direct incision and balloon dilation used to create gastrotomies for natural orifice translumenal endoscopic surgery (NOTES) in the porcine model.

BACKGROUND

This study aimed to assess the feasibility, safety, and efficacy of a prototype device (the one-step needle sphincterotome) versus direct incision and balloon dilation for creating transgastric access to the peritoneal cavity in a porcine model.

METHODS

In five swine, 24 gastrotomies were created using direct incision followed by balloon dilation (group A) or by the one-step needle sphincterotome (group B) in an in vivo nonsurvival model. The one-step needle sphincterotome is a novel instrument comprising two components including a retractable needleknife and a pull-type sphincterotome on the same instrument shaft, reducing the need to exchange instruments.

RESULTS

The 24 gastrotomies created in the five swine all were successful. The mean time required for creation of a gastrotomy was 613.08 ± 289.64 s in group A and 310.58 ± 137.39 s in group B. The total procedural time was 830.42 ± 296.17 s in group A and 529 ± 143.97 s in group B. Both were significantly shorter in the prototype device group (P = 0.002). The mean length of gastrotomy, mean number of clips required for closure, and mean overall closure time were not significantly different. One swine from each group suffered morbidities and another experienced mortality.

CONCLUSIONS

The one-step needle sphincterotome hastened the creation of gastrotomies for natural orifice translumenal endoscopic surgery (NOTES). The gastrotomies created by both procedures were effective means of gaining peritoneal access, and neither method demonstrated superiority in expediting closure. However, the initial blind transgastric incision by a needleknife may be associated with a risk of injuring surrounding structures.