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

Hypoglycemia Clinical Trial

— LABOR  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640947
• Other study ID #: ONZ-2022-0015
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Ghent
• Contact: Pieter Hindryckx, Prof.
• Phone: 093320726
• Email: pieter.hindryckx[@]uzgent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Gastric Bypass
• Gastric Outlet Obstruction
• Hypoglycemia
• Pyloric Stenosis
• Steatohepatitis

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital, Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Technical success rate	Correct placement of the lumen-apposing metal stent in the desired position, scored yes/no	12 months
Secondary	Duration of the procedure	time interval from scope introduction to successful deployment of the lumen-apposing metal stent.	12 months
Secondary	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
Secondary	Reintervention rate	endoscopic and/or surgical, reason should be clearly mentioned: due to loss of stent patency, stent migration, side-effects,…	12 months