Novel Endoscopic Clip For Effective Management of Gastrointestinal Perforations: A Feasibility Study in a Porcine Model.

Abstract

Background: Gastrointestinal (GI) perforations typically occur as complications following endoscopic procedures or intestinal anastomosis surgery. Endoscopic closure of these perforations is desirable as it avoids the risks associated with surgery. Although several endoscopic devices have been developed to address this issue, none have yet demonstrated consistently effective clinical outcomes. This study introduces a novel endoscopic clip assembly designed to overcome these challenges.

Materials and methods: The Z-shaped clip, named the kinetic utility (KU) clip, was constructed with nitinol, allowing it to operate at 45 °C. When the clip is delivered endoscopically, it can close perforations with a predeformed configuration that is triggered by temperature. Ex vivo experiments were conducted using porcine stomach tissue to compare the performance of the KU clip with through-the-scope clips (TTSCs). Maximal force and area under the curve (AUC) on the force-displacement curve were measured to assess the retention capability of the clip in tissue. The in vivo experiment involved creating iatrogenic perforations in a pig, applying the KU clip, and monitoring its healing and safety outcomes.

Results: Ex vivo experiments showed a difference between the TTSC and KU groups with a P-value of 0.08 for maximal force and 0.01 for AUC. The in vivo experiment validates the effectiveness of the KU clip, as there was complete healing of the perforation site with no significant adverse reactions during the experimental period.

Conclusions: The KU clip demonstrates potential as a versatile and effective tool for endoscopic management of GI perforations.