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NCT Number: NCT05640947

Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass

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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Key information

Conditions

Hypoglycemia Digestive System Diseases Fatty Liver Gastric Bypass Gastric Outlet Obstruction Gastrointestinal Diseases Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases Parenteral Support Steatohepatitis Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint-Jan Brugge, Bruges, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • a platelet count <150000/µl AND
  • liver stiffness measured by elastometry equal to or more than 20 kPa (Baveno guidelines).
  • 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

Treatment and study plan

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.

Other names: LAMS

Primary outcomes

  1. clinical succes rate

    Time frame: 6 months

    • for patients needing parenteral support: the number of parenteral supplements over a 6-month timeframe.
    • 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.
    • for patients with gastric outlet obstruction: resolution of gastric outlet obstruction- associated symptoms at 6 months post-intervention.
    • 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.

Secondary outcomes

  1. Technical success rate

    Time frame: 12 months

    Correct placement of the lumen-apposing metal stent in the desired position, scored yes/no

  2. Duration of the procedure

    Time frame: 12 months

    time interval from scope introduction to successful deployment of the lumen-apposing metal stent.

  3. Complication rate

    Time frame: 12 months

    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:

    • mild: requiring admission or prolongation of planned admission <3 days;
    • moderate: requiring prolongation of planned admission to 3-10 days;
    • severe: requiring prolongation of planned admission to more than 10 days or requiring surgery;
    • fatal: leading to death

  4. Reintervention rate

    Time frame: 12 months

    endoscopic and/or surgical, reason should be clearly mentioned: due to loss of stent patency, stent migration, side-effects,…

Study contacts

Contact information is provided by the study sponsor or research team.

Pieter Hindryckx, Prof.

CONTACT

[email protected]

093320726

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: LABOR

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Dec 7, 2022
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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