Actively Recruiting
Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-Y Gastric Bypass: a Proof of Concept Study
Led by University Hospital, Ghent · Updated on 2025-10-08
20
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
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 procedure's effectiveness and safety. Overall involvement includes the treatment procedure and follow-up visits for outcome measurement and monitoring over at least one year.
CONDITIONS
Brief Title
Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients requiring parenteral nutritional support not correctable by diet or supplements
- Patients with persistent, disabling dumping syndrome despite dietary intervention
- Patients with refractory marginal ulcers causing stenosis and feeding difficulties
- Patients with advanced liver fibrosis (F3 or F4) and signs of liver decompensation after bypass surgery
You will not qualify if you...
- Uncorrectable coagulopathy
- Significant portal hypertension demonstrated by varices and/or hepatic venous pressure gradient ≥10mm Hg and/or low platelet count with high liver stiffness
- Pregnant or breastfeeding women, or women unable to ensure effective contraception during the study
- Karnofsky performance index less than 60
- Vulnerable patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day
Participants undergo an endoscopic ultrasound-guided gastro-gastrostomy procedure using a large diameter lumen-apposing metal stent to reverse bypass.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
AZ Sint-Jan Brugge
Bruges, Belgium
Actively Recruiting
2
University Hospital, Ghent
Ghent, Belgium, 9000
Actively Recruiting
Research Team
P
Pieter Hindryckx, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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