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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAMS gastro-gastrostomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical succes rate |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Correct placement of the lumen-apposing metal stent in the desired position, scored yes/no | 12 months |
| Duration of the procedure | time interval from scope introduction to successful deployment of the lumen-apposing metal stent. |
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Inclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pieter Hindryckx, Prof. | Contact | 093320726 | pieter.hindryckx@uzgent.be |
| Name | Affiliation | Role |
|---|---|---|
| Pieter Hindryckx, Prof. | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan Brugge | Recruiting | Bruges | Belgium |
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Placement of a 20mm lumen-apposing metal stent (Hot AxiosR, Boston Scientific) between the gastric pouch or the jejunum and the excluded stomach. The procedure will be performed by a physician with sufficient experience in the technique (more than 30 lumen-apposing metal stent placements of which more than 5 gastro-gastrostomies, the latter being the procedure that will be performed for the study). The proximal flange of the LAMS is preferably placed in the blind jejunal loop or, if this is not feasible, at least as far as possible from the gastro-oesophageal junction.
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|
|
| 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:
| 12 months |
| Reintervention rate | endoscopic and/or surgical, reason should be clearly mentioned: due to loss of stent patency, stent migration, side-effects,… | 12 months |
| University Hospital, Ghent | Recruiting | Ghent | 9000 | Belgium |
|
| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D017219 | Gastric Outlet Obstruction |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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