Actively Recruiting
G-POEM vs PEG-J in Gastroparesis Patients
Led by Maastricht University Medical Center · Updated on 2024-04-17
50
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up. Study population: 50 patients with therapy refractory GP on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of PEG-J/ G-POEM. Intervention: Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment. Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point.
CONDITIONS
Official Title
G-POEM vs PEG-J in Gastroparesis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with GP
- 13C octanoic acid test or gastric scintigraphy (minimal 4-hour measurement) within the past twelve months
- 18 years old
You will not qualify if you...
- < 18 years old
- Medical history of stomach surgery in which resection of antrum and/ or pylorus took place
- Medical history of surgical or laparoscopic pyloromyotomy
- Gastric bypass
- Current opioid use
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maastricht University Medical Center
Maastricht, Zuid-Limburg, Netherlands, 6229 HX
Actively Recruiting
Research Team
K
Kim Sweerts
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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