Stent could replace surgery for gastric bypass reversal
NCT ID NCT05640947
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if a tube-like device called a stent, placed through a scope, can reverse gastric bypass surgery in 20 people who have serious complications like low blood sugar, blockages, or liver problems. The goal is to see if the stent works as well as surgery to fix these issues. Participants will be followed for 6 months to check if symptoms improve.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AZ Sint-Jan Brugge
RECRUITINGBruges, Belgium
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University Hospital, Ghent
RECRUITINGGhent, 9000, Belgium
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