Using a special stent to help reverse gastric bypass surgery

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

This study is testing whether a special stent can help people who need their gastric bypass reversed feel better and improve their nutrition without needing surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Ghent (Academic / other)
• Locations: 2 sites (Bruges and 1 other locations)
• Trial ID: NCT05640947 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the effectiveness of an endoscopically placed lumen-apposing metal stent as a non-surgical alternative for patients requiring reversal of their gastric bypass. The study focuses on patients with specific conditions such as hypoglycemia, gastric outlet obstruction, and severe liver fibrosis. Participants will receive the Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System to assess the stent's ability to alleviate symptoms and improve nutritional status. The study is open-label, meaning both researchers and participants will know the treatment being administered.

Who should consider this trial

Good fit: Ideal candidates include patients requiring parenteral nutritional support, those with symptomatic dumping syndrome, patients with refractory marginal ulcers, and individuals with severe liver fibrosis post-bypass.

Not a fit: Patients with uncorrectable coagulopathy or significant portal hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive option for patients needing gastric bypass reversal, potentially improving their quality of life.

How similar studies have performed: While this approach is innovative, similar studies exploring endoscopic interventions for gastric bypass complications have shown promise, indicating potential for success.

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

Where this trial is running

Bruges and 1 other locations

• AZ Sint-Jan Brugge — Bruges, Belgium (Recruiting)
• University Hospital, Ghent — Ghent, Belgium (Recruiting)

Study contacts

• Principal investigator: Pieter Hindryckx, Prof. — University Hospital, Ghent
• Study coordinator: Pieter Hindryckx, Prof.

Conditions Hypoglycemia; Gastric Outlet Obstruction; Steatohepatitis; Parenteral Support; Gastric Bypass