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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
AZ Sint-Jan Brugge
Bruges, Belgium
RECRUITINGUniversity Hospital, Ghent
Ghent, Belgium
RECRUITINGclinical succes rate
1. for patients needing parenteral support: the number of parenteral supplements over a 6-month timeframe. 2. for patients with symptomatic hypoglycemia: resolution of hypoglycemia- associated complaints + negative hypoglycemia-provocative testing (oral glucose tolerance test and/or mixed meal test) at 6 months post-intervention. 3. for patients with gastric outlet obstruction: resolution of gastric outlet obstruction- associated symptoms at 6 months post-intervention. 4. for patients with steatohepatitis and signs of liver failure: improvement of liver function (significant drop in bilirubin/INR; increase in serum albumin) at 6 months post-intervention.
Time frame: 6 months
Technical success rate
Correct placement of the lumen-apposing metal stent in the desired position, scored yes/no
Time frame: 12 months
Duration of the procedure
time interval from scope introduction to successful deployment of the lumen-apposing metal stent.
Time frame: 12 months
Complication rate
These include procedure-related complications such as bleeding, perforation, stent migration, peritonitis, reflux disease … Complications will be divided into early (within 24h) and late (after 24h but within 30 days) complications. The severity of each complication will be scored as followed: 1. mild: requiring admission or prolongation of planned admission \<3 days; 2. moderate: requiring prolongation of planned admission to 3-10 days; 3. severe: requiring prolongation of planned admission to more than 10 days or requiring surgery; 4. fatal: leading to death
Time frame: 12 months
Reintervention rate
endoscopic and/or surgical, reason should be clearly mentioned: due to loss of stent patency, stent migration, side-effects,…
Time frame: 12 months
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