Using a special stent to help reverse gastric bypass surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: pieter.hindryckx@uzgent.be
• Phone: 093320726

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding glucagon and sugar metabolism after meals in people with and without PBH after weight-loss surgery

  This study tests how glucagon and post-meal glucose handling differ between people who have post-bariatric surgery hypoglycemia and those who don’t.

  Recruiting at 2 sites Phase 4 Joslin Diabetes Center · Birmingham, Alabama and 1 other locations · NCT07818707

• Stomach-Partitioning Surgery to Help Block Obstruction in Advanced Stomach Cancer

  This trial tests whether stomach-partitioning gastrojejunostomy helps people with unresectable, advanced stomach cancer better tolerate food after surgery than the standard approach.

  Recruiting Gyeongsang National University Hospital · Changwon, Gyeongsangnam-do · NCT07749326

• Gastrointestinal Magnet System for Creating a Gastroenterostomy

  This study tests the GT Metabolic Magnet System to see if it can safely create a side-to-side gastroenterostomy for adults with gastric outlet obstruction.

  Recruiting GT Metabolic Solutions, Inc. · Prague · NCT07609511

• Fear of hypoglycemia in people with diabetes

  This study looks at how fear of low blood sugar affects how people with diabetes take their medications and manage their diet.

  Recruiting Bilecik Seyh Edebali Universitesi · Bilecik · NCT07329985

• GT Metabolic Magnet System to create side-to-side connections in the stomach or small intestine

  This study will test whether the GT Metabolic Magnet System can safely create side-to-side connections in the stomach or small intestine for adults with gastric outlet obstruction, partial small bowel obstruction, or superior mesenteric artery syndrome.

  Recruiting GT Metabolic Solutions, Inc. · Westmount, Quebec · NCT07317076

• How sexual activity affects low blood sugar risk in adults with insulin-treated diabetes who use a CGM

  This study will see if sexual activity changes the risk of low blood sugar in adults with type 1 or type 2 diabetes who use insulin and a continuous glucose monitor.

  Recruiting Medical University of Warsaw · Warsaw · NCT07286500

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.