Using an Endoscopic Ultrasound-Guided Large Diameter Metal Stent to Reverse Roux-en-Y Gastric Bypass as an Alternative to Surgery

What this Trial Is About

Researchers are investigating whether using an endoscopically placed lumen apposing metal stent can be an effective alternative to surgery for patients who need reversal of their Roux-en-Y gastric bypass. This open-label pilot study focuses on patients with clear indications for bypass reversal due to complications such as hypoglycemia, gastric outlet obstruction, steatohepatitis, or difficulty with parenteral support. The study involves an endoscopic ultrasound-guided procedure using the Hot AXIOS Stent and Electrocautery-Enhanced Delivery System to create a gastro-gastrostomy. The excluded stomach is identified and punctured under fluoroscopic control, and a 20mm diameter lumen-apposing metal stent is placed to connect the stomach sections. This device-based intervention is performed following manufacturer instructions and fluoroscopy is used to confirm placement. Participants will be monitored for clinical success at 6 months, with additional assessments over 12 months including technical success, procedure duration, complication rates, and need for reintervention. The study tracks these outcomes to evaluate the procedures effectiveness and safety. Overall involvement includes the treatment procedure and follow-up visits for outcome measurement and monitoring over at least one year.

Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass