Overview
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.
Eligibility
Inclusion Criteria:
- Patients with GP
- 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