Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy
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.
| Condition(s) | Hypoglycemia, Gastric Outlet Obstruction, Steatohepatitis, Parenteral Support, Gastric Bypass |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital, Ghent |
| Locations | Bruges, Belgium; Ghent, Belgium |
| Start date | 2023-01-30 |
| NCT ID | NCT05640947 |
| Official listing | https://clinicaltrials.gov/study/NCT05640947 |