NCT06372132 G-POEM vs PEG-J in Gastroparesis Patients
| NCT ID | NCT06372132 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Gastroparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2027-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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 Criteria
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