Back to resultsENDOSCOPIC 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 (LABOR)
Primary Purpose
Hypoglycemia, Gastric Outlet Obstruction, Steatohepatitis
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System
Sponsored by
About this trial
This is an interventional treatment trial for Hypoglycemia
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
Sites / Locations
- University Hospital, GhentRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LAMS gastro-gastrostomy
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Technical success rate
Correct placement of the lumen-apposing metal stent in the desired position, scored yes/no
Duration of the procedure
time interval from scope introduction to successful deployment of the lumen-apposing metal stent.
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
Reintervention rate
endoscopic and/or surgical, reason should be clearly mentioned: due to loss of stent patency, stent migration, side-effects,…
Full Information
NCT ID
NCT05640947
First Posted
November 28, 2022
Last Updated
May 2, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT05640947
Brief 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
Acronym
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-CONCEPT STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia, Gastric Outlet Obstruction, Steatohepatitis, Parenteral Support, Gastric Bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LAMS gastro-gastrostomy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System
Other Intervention Name(s)
LAMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
clinical succes rate
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Technical success rate
Description
Correct placement of the lumen-apposing metal stent in the desired position, scored yes/no
Time Frame
12 months
Title
Duration of the procedure
Description
time interval from scope introduction to successful deployment of the lumen-apposing metal stent.
Time Frame
12 months
Title
Complication rate
Description
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
Time Frame
12 months
Title
Reintervention rate
Description
endoscopic and/or surgical, reason should be clearly mentioned: due to loss of stent patency, stent migration, side-effects,…
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pieter Hindryckx, Prof.
Phone
093320726
Email
pieter.hindryckx@uzgent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter Hindryckx, Prof.
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter Hindryckx, MD, PhD
Phone
+32 9 332 07 26
Email
pieter.hindryckx@uzgent.be
First Name & Middle Initial & Last Name & Degree
Pieter Hindryckx, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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