Gastroparesis
Conditions
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.
Interventions
PROCEDUREG-POEM
Gastric Per-Oral Endoscopic Pyloromyotomy
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 6 months. | 6 months | A treatment success will be defined as a decrease of at least one point on the GCSI (range 0-5), representing a clinically relevant difference, six months after intervention in comparison with baseline before intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 12 months. | 12 months | We hypothesize that the treatment success rate is higher in the G-POEM group in comparison with the PEG-J intervention group twelve months after intervention compared to baseline. |
| Degree of quality of life using the PAGI-QOL in the G-POEM group in comparison with the PEG-J intervention six months after intervention. | 6 months | We hypothesize that quality of life is higher in the G-POEM intervention group compared to the PEG-J intervention group six months after treatment. |
| Number and severity of (s)AEs in the treatment groups. | 12 months | We hypothesize that no severe adverse events take place and the only mild to moderate adverse events that will take place are expected to be abdominal pain, pneumoperitoneum, mucosal injury, or wound infection. |
| Predictive value of the etiology of gastroparesis on treatment outcomes following G-POEM by measuring the rate of treatment success quantified by improvements in the GCSI-score. | 6-12 months | We hypothesize that differences in etiology can predict treatment success after G-POEM. |
| Predictive value of the etiology of gastroparesis on treatment outcomes following PEG-J by measuring the rate of treatment success quantified by improvements in the GCSI-score. | 6-12 months | We hypothesize that differences in etiology can predict treatment success after PEG-J. |
Countries
Netherlands
Contacts
Primary ContactKim Sweerts
Outcome results
None listed