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Recruiting NCT05640947

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

No phase Interventional Hypoglycemia Gastric Outlet Obstruction Steatohepatitis Parenteral Support

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System.
Who it may be relevant to
Registry conditions: Hypoglycemia, Gastric Outlet Obstruction, Steatohepatitis, Parenteral Support. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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-apposi

Primary outcome measures

  • clinical succes rate [Time frame: 6 months]
Secondary outcome measures (4)
  • Technical success rate [Time frame: 12 months]
  • Duration of the procedure [Time frame: 12 months]
  • Complication rate [Time frame: 12 months]
  • Reintervention rate [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 2 centers
  • AZ Sint-Jan Brugge — Bruges
  • University Hospital, Ghent — Ghent

Identifiers

NCT: NCT05640947 · ONZ-2022-0015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗