Status:
RECRUITING
Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass
Lead Sponsor:
University Hospital, Ghent
Conditions:
Hypoglycemia
Gastric Outlet Obstruction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
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
Key Trial Info
Start Date :
January 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05640947
Start Date
January 30 2023
End Date
February 1 2028
Last Update
October 8 2025
Active Locations (2)
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1
AZ Sint-Jan Brugge
Bruges, Belgium
2
University Hospital, Ghent
Ghent, Belgium, 9000