A novel lumen-apposing stent for transluminal drainage of nonadherent extraintestinal fluid collections.

BACKGROUND AND STUDY AIMS

Tubular stents have been used to accomplish endoscopic transluminal drainage, but do not impart lumen-to-lumen anchorage. We evaluated a novel lumen-apposing stent designed for enteric drainage of nonadherent lumens.

MATERIAL AND METHODS

Ex vivo benchtop testing was performed to quantify various physical and performance metrics of the stent (Axios). A simulator was developed to test the stent deployment through an echoendoscope. Survival experiments were performed on four pigs. Under endosonographic guidance, a cholecystogastrostomy tract was created and the stent was deployed across the lumens. Direct cholecystoscopy was performed. Surveillance gastroscopy was performed at weekly intervals for up to 8 weeks. Measured outcomes were procedural success, safety, and device durability and patency.

RESULTS

In benchtop testing, the Axios stent withstood various vector forces of movement, yet allowed easy removability from the simulated tissue. The stent was successfully deployed across the stomach and gallbladder lumens in all four animals without complication. Direct cholecystoscopy and contrast injection documented the absence of tissue trauma and leakage. Gastroscopy at weekly intervals showed the stent in stable position without dislodgment. The stent remained patent in all animals. The covering remained intact and there was no hyperplastic tissue ingrowth or overgrowth, or tissue injury. One stent was removed at 4 weeks. On necropsy, the gallbladders showed focal adherence to the stomach at the site of cystogastrostomy with a negative leak test.

CONCLUSIONS

The Axios stent enables the creation of a robust and reliable conduit between nonadherent lumens around the gastrointestinal tract.