Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass
Recruiting now · Not applicable
Conditions studied: Hypoglycemia, Gastric Outlet Obstruction, Steatohepatitis, Parenteral Support, Gastric Bypass
In brief
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.
Key facts
- Study ID
- NCT05640947
- Run by
- University Hospital, Ghent
- People needed
- 20
- Starts
- 2023-01-30
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2025-10-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Group 1) patients needing any kind of parenteral nutritional support (eg. hypo- albuminemia, hypovitaminoses, mineral deficiencies,...) that can not be corrected by dietary intervention/oral supplementation
- Group 2) patients with persistent invalidating symptomatic dumping syndrome despite optimal dietary intervention (typical complaints are headache, sweating, trembling, weakness and feeling hungry).
- Group 3) patients with a refractory marginal ulcers with stenosis of the gastrojejunostomy leading to feading difficulties.
- Group 4) patients with F3 or F4 liver fibrosis and a tendency to decompensation after bypass surgery, as demonstrated by an increase in serum bilirubin/INR and/or lowering of serum albumin.
You may not qualify if…
- Uncorrectable coagulopathy
- Presence of significant portal hypertension as demonstrated by 2.1) the presence of esophageal and/or gastric varices AND/OR 2.2) a hepatic venous pressure gradient (if measured) equal to or more than 10mm Hg AND/OR 2.3) the combination of
- a platelet count <150000/µl AND
- liver stiffness measured by elastometry equal to or more than 20 kPa (Baveno guidelines).
- Pregnant women, breastfeeding women or women that can not assure adequate anticonception for the duration of the study (based on anamnesis).
- Karnofsky index less than 60
- Vulnerable patients
Where it is running
- AZ Sint-Jan Brugge — Bruges, Belgium (enrolling)
- University Hospital, Ghent — Ghent, Belgium (enrolling)
Full record on ClinicalTrials.gov
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