Interventional EUS has allowed for the endoscopic management of conditions that previously required abdominal surgery, including transmural drainage of the gallbladder (EUS-GBD). These procedures are technically demanding and can be associated with serious adverse events. The aim of this study was to establish the feasibility and safety of a novel endosonography-guided suturing device, which allows apposition of the gastrointestinal lumen and gallbladder for EUS-GBD, reducing technical demands and improving safety.

A preclinical survival study was conducted on 6 domestic pigs. Animals were randomized in a 2:1 ratio to undergo EUS-GBD with the suturing device preceding freehand lumen-apposing metal stent (LAMS) deployment or LAMS alone. Ease of device use, stent deployment, technical success, and intraprocedural adverse events were recorded. The animals were kept alive for 30 days, which was followed by euthanasia, necropsy, and histologic analysis.

Technical success was achieved in all animals (4 suture + LAMS and 2 LAMS only). Suture fixation significantly decreased the distance from the gastrointestinal lumen to the gallbladder (17.6-6.7 mm, P = .001), allowing for successful LAMS deployment in all 4 cases without adverse events. One intraprocedural stent maldeployment was reported in the control group. No adverse events were identified in either group during the survival period or on necropsy.

This study demonstrates the safety and effectiveness of a novel device that allows for endoscopic anchoring of the gallbladder to the gastrointestinal lumen. This facilitated the successful completion of EUS-GBD and may have implications for other interventional EUS procedures.