Comparing G-POEM and PEG-J treatments for gastroparesis
'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'
This study is testing whether a new procedure called G-POEM or a feeding tube method called PEG-J can help people with stubborn gastroparesis feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Zuid-Limburg) |
| Trial ID | NCT06372132 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two treatment options, G-POEM and PEG-J, for patients suffering from refractory gastroparesis. It involves a randomized, non-blinded controlled design with two groups: one receiving G-POEM and the other receiving PEG-J. Treatment success will be assessed using the Gastroparesis Cardinal Symptom Index (GCSI) at baseline and six months post-intervention, with a potential crossover after the follow-up period. The study aims to enroll 50 patients who have not responded to standard dietary and pharmacological treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with diagnosed gastroparesis who have not responded to conventional therapies.
Not a fit: Patients under 18, those with a history of specific stomach surgeries, or current opioid users may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with refractory gastroparesis.
How similar studies have performed: Other studies have shown promising results with G-POEM for gastroparesis, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Maastricht, Zuid-Limburg
- Maastricht University Medical Center — Maastricht, Zuid-Limburg, Netherlands (Recruiting)
Study contacts
- Study coordinator: Kim Sweerts
- Email: kim.sweerts@maastrichtuniversity.nl
- Phone: +31 88 388 7298
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.