Treatment outcome of Gastric Peroral Endoscopic Pyloromyotomy in comparison with Percutaneous Endoscopic Gastrostomy with Jejunal extension in medically refractory gastroparesis: a prospective randomized controlled trial.
Recruiting
- Conditions
- GastropareseGP10017977
- Registration Number
- NL-OMON56563
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
- Patients with therapy refractory gastroparesis
- 13C octanoic acid test or gastric scintigraphy (minimal 4-hour measurement)
within the past twelve months
- >= 18 years old
Exclusion Criteria
- < 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>A clinically meaningful treatment success six months after G-POEM treatment,<br /><br>measured using the GCSI-score defined as a decrease of 1 point or more.</p><br>
- Secondary Outcome Measures
Name Time Method