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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoglycemia; Gastric Outlet Obstruction; Steatohepatitis; Gastric Bypass; Parenteral Support
• Intervention / Treatment: Device: The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pieter Hindryckx, Prof.; Phone Number: 093320726; Email: pieter.hindryckx@uzgent.be

Study Locations

• Belgium
  • Bruges, Belgium
    • Recruiting
    • AZ Sint-Jan Brugge
    • Contact: Christophe Snauwaert, Dr.; Phone Number: 0486804952; Email: Christophe.Snauwaert@azsintjan.be
  • Ghent, Belgium, 9000
    • Recruiting
    • University Hospital, Ghent
    • Contact: Pieter Hindryckx, MD, PhD; Phone Number: +32 9 332 07 26; Email: pieter.hindryckx@uzgent.be
    • Principal Investigator: Pieter Hindryckx, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: LAMS gastro-gastrostomy

Device: The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical succes rate	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.	6 months

Secondary Outcome Measures

Outcome Measure	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.	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: 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	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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Pieter Hindryckx, Prof., University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Glucose Metabolism Disorders; Liver Diseases; Nutritional and Metabolic Diseases; Hypoglycemia; Fatty Liver; Gastric Outlet Obstruction
• Other Study ID Numbers: ONZ-2022-0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes