# Novel designed balloon specialized for EUS-guided gastroenterostomy: A pilot study

## TL;DR

This pilot study evaluates a new balloon-assisted device for EUS-guided gastroenterostomy, showing it is safe and effective with high success rates and minimal complications.

## Contribution

A novel balloon-assisted device for EUS-guided gastroenterostomy is introduced and tested for safety and feasibility.

## Key findings

- The device achieved a 100% technical success rate and 95% clinical success rate.
- Procedure time averaged 29.3 minutes with minimal water infusion and no major adverse events.

## Abstract

We recently developed a balloon-assisted device for EUS-guided gastroenterostomy (EUS-GE) to enhance the safety and convenience of the procedure. This pilot study was conducted to evaluate the safety and feasibility of this device.

A retrospective analysis of data of patients who underwent EUS-GE using this balloon-assisted device at our institution from March 2024 to July 2024 was conducted. The primary end point was the procedure time, and the secondary end points were the volume of water injection, technical success rate, clinical success rate, and adverse events (AEs).

A total of 20 patients (male: 55%; female: 45%) were enrolled, with a mean age of 67.7 ± 9.9 years. The mean procedure time was 29.3 ± 9.4 minutes, and the mean intraoperative water infusion in the jejunum was 92.5 (80–117.5) mL. The technical success rate was 100% (20/20). The clinical success rate was 95% (19/20). One patient (5%) experienced mild abdominal pain after the procedure. No other AEs, such as bleeding, perforation, stent occlusion, or migration, were observed during follow-up. The median follow-up duration was 132 (74–170) days.

The balloon-assisted device facilitates the application of EUS-GE, with short procedure time, less intraoperative water injection, high technical success rate, and low incidence of AEs.