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

Not Applicable

Recruiting

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

• Registration Number: NCT05640947
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Study First Posted: 2022-12-07
• Study Start: 2023-01-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-10
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LAMS gastro-gastrostomy	The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System	-

Primary Outcome Measures

Name	Time	Method
clinical succes rate	6 months	1. for patients needing parenteral support: the number of parenteral supplements over a 6-month timeframe.; 2. 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.; 3. for patients with gastric outlet obstruction: resolution of gastric outlet obstruction- associated symptoms at 6 months post-intervention.; 4. 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 Outcome Measures

Name	Time	Method
Technical success rate	12 months	Correct placement of the lumen-apposing metal stent in the desired position, scored yes/no
Duration of the procedure	12 months	time interval from scope introduction to successful deployment of the lumen-apposing metal stent.
Reintervention rate	12 months	endoscopic and/or surgical, reason should be clearly mentioned: due to loss of stent patency, stent migration, side-effects,...
Complication rate	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: 1. mild: requiring admission or prolongation of planned admission \<3 days; 2. moderate: requiring prolongation of planned admission to 3-10 days; 3. severe: requiring prolongation of planned admission to more than 10 days or requiring surgery; 4. fatal: leading to death

Trial Locations

Locations (1)

University Hospital, Ghent; 🇧🇪 Ghent, Belgium