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

NCT05640947 | Recruiting FDA Device

• 1 other identifier: ONZ-2022-0015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypoglycemia; Gastric Outlet Obstruction; Steatohepatitis; Parenteral Support; Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• clinical succes rate

  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.

  6 months

Secondary Outcomes (4)

• Technical success rate

  12 months

• Duration of the procedure

  12 months

• Complication rate

  12 months

• Reintervention rate

  12 months

Study Arms (1)

LAMS gastro-gastrostomy

EXPERIMENTAL

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

Interventions

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.

Also known as: LAMS

LAMS gastro-gastrostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

AZ Sint-Jan Brugge

Bruges, Belgium

RECRUITING

University Hospital, Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Hypoglycemia; Gastric Outlet Obstruction; Fatty Liver

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases

Study Officials

• Pieter Hindryckx, Prof.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter Hindryckx, Prof.

CONTACT

093320726; pieter.hindryckx@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placement of a 20mm lumen-apposing metal stent (Hot AxiosR, Boston Scientific) between the gastric pouch or the jejunum and the excluded stomach. The procedure will be performed by a physician with sufficient experience in the technique (more than 30 lumen-apposing metal stent placements of which more than 5 gastro-gastrostomies, the latter being the procedure that will be performed for the study). The proximal flange of the LAMS is preferably placed in the blind jejunal loop or, if this is not feasible, at least as far as possible from the gastro-oesophageal junction.

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: January 30, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)