A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis

Mayo Clinic

Status

Completed

Conditions

Gastroparesis

Treatments

Procedure: Sham Gastric peroral endoscopic myotomy.

Procedure: Gastric peroral endoscopic myotomy.

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04869670

21-001928

R01DK125680 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.