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

Launched by UNIVERSITY HOSPITAL, GHENT · Nov 28, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new method for reversing gastric bypass surgery using a special metal stent placed through an endoscope, which is a flexible tube with a camera. The goal is to see if this approach can help patients who are having serious problems after their gastric bypass, such as severe nutritional deficiencies, ongoing dumping syndrome (which causes uncomfortable symptoms like sweating and weakness after eating), or feeding difficulties due to ulcers. This method could potentially be a safer alternative to traditional surgery.

To be eligible for the trial, participants must be between the ages of 65 and 74 and fall into specific groups, including those needing nutritional support that can't be fixed with diet or supplements, those experiencing severe symptoms from dumping syndrome, patients with problematic ulcers, or individuals with serious liver issues. If someone joins the study, they can expect to receive treatment using the stent and will be monitored closely for its effectiveness and safety. It's important to note that certain conditions, like severe bleeding disorders or pregnancy, may exclude individuals from participating.

Gender

ALL

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:
• • 1. Uncorrectable coagulopathy
• • 2. 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
• • 1. a platelet count \<150000/µl AND
• • 2. liver stiffness measured by elastometry equal to or more than 20 kPa (Baveno guidelines).
• • 3. Pregnant women, breastfeeding women or women that can not assure adequate anticonception for the duration of the study (based on anamnesis).
• • 4. Karnofsky index less than 60
• • 5. Vulnerable patients