Actively Recruiting
Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass
Led by University Hospital, Ghent · Updated on 2025-10-08
20
Participants Needed
2
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this open-label pilot study is to investigate whether an endoscopically placed lumen apposing metal stent is an effective alternative to surgery in patients that have a clear indication for reversal of their gastric bypass.
CONDITIONS
Official 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...
- Patients requiring parenteral nutritional support not correctable by diet or oral supplements
- Patients with persistent disabling dumping syndrome despite optimal dietary management
- Patients with refractory marginal ulcers and gastrojejunostomy stenosis causing 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 bleeding disorders
- Significant portal hypertension shown by esophageal or gastric varices, or hepatic venous pressure gradient ≥10 mm Hg
- Platelet count below 150,000/µl combined with liver stiffness ≥20 kPa
- Pregnant or breastfeeding women, or women unable to ensure 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
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.
CONTACT
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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