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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-CONCEPT STUDY

Sponsor
University Hospital, Ghent (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05640947
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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-CONCEPT STUDY
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. clinical succes rate [6 months]

      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.

    Secondary Outcome Measures

    1. Technical success rate [12 months]

      Correct placement of the lumen-apposing metal stent in the desired position, scored yes/no

    2. Duration of the procedure [12 months]

      time interval from scope introduction to successful deployment of the lumen-apposing metal stent.

    3. 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: 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

    4. Reintervention rate [12 months]

      endoscopic and/or surgical, reason should be clearly mentioned: due to loss of stent patency, stent migration, side-effects,…

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    3. a platelet count <150000/µl AND

    4. liver stiffness measured by elastometry equal to or more than 20 kPa (Baveno guidelines).

    5. Pregnant women, breastfeeding women or women that can not assure adequate anticonception for the duration of the study (based on anamnesis).

    6. Karnofsky index less than 60

    7. Vulnerable patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital, Ghent Ghent Belgium 9000

    Sponsors and Collaborators

    • University Hospital, Ghent

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Ghent
    ClinicalTrials.gov Identifier:
    NCT05640947
    Other Study ID Numbers:
    • ONZ-2022-015
    First Posted:
    Dec 7, 2022
    Last Update Posted:
    Dec 7, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Fatty Liver
    Gastric Outlet Obstruction
    Pyloric Stenosis
    Hypoglycemia

    Study Results

    No Results Posted as of Dec 7, 2022