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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
AZ Sint-Jan Brugge
RECRUITING
Bruges
University Hospital, Ghent
RECRUITING
Ghent
Contact Information
Primary
Pieter Hindryckx, Prof.
pieter.hindryckx@uzgent.be
093320726
Time Frame
Start Date: 2023-01-30
Estimated Completion Date: 2028-02
Participants
Target number of participants: 20
Treatments
Experimental: LAMS gastro-gastrostomy
Sponsors
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov