Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass
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 Concent Study
University Hospital, Ghent
20 participants
Jan 30, 2023
INTERVENTIONAL
Conditions
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 indication for reversal of their gastric bypass.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
EUS-guided gastro-gastrostomy using the Hot Axios device: Using a therapeutic endoscopic ultrasound endoscope with a working channel of 3.7mm and under fluoroscopic control, the excluded stomach will be identified and punctured with a 19G needle. Contrast injection will confirm the good position of the needle in the excluded stomach. If needed, the excluded stomach will be filled with blue-stained aqua (5% indigocarmine) until a sufficient distension is obtained for placement of the lumen-apposing metal stent. A lumen-apposing metal stent with a diameter of 20mm will be used according to the manufacterers' instructions to create a gastrogastrostomy. Position will be checked with fluoroscopy.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05640947