Overview
The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.
Eligibility
Inclusion Criteria:
- Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
- Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit.
- Refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3 antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
- Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4 hours or > 75% retained at 2 hours. The qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying.
- No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.
Exclusion Criteria:
- Another active disorder which could explain symptoms in the opinion of the investigator.
- Gastric retention of solids at 4 hours < 25% or < 75% at 2 hours.
- Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider.
- Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater.
- Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.
- New medications for gastroparesis-related symptoms started within 1 month prior to registration.
- Pregnancy or nursing.
- Failure to give informed consent.
- Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
- Botox injection into the pylorus within 3 months prior to registration.
- Allergy to eggs or Egg Beaters and Ensure.