A Pilot and Feasibility Trial of G-POEM for Gastroparesis to Assess Safety, Physiological Mechanisms and Efficacy

Mayo Clinic2 sites in 1 country2 target enrollmentJuly 12, 2023

ConditionsGastroparesis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastroparesis
Sponsor: Mayo Clinic
Enrollment: 2
Locations: 2
Primary Endpoint: GCSI-DD change
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 12, 2023

End Date

March 3, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Michael Camilleri, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Outcomes

Primary Outcomes

GCSI-DD change

Time Frame: Baseline to 48 weeks post treatment

The effect of GPOEM on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) which has been designed to assess symptoms associated with gastroparesis. Symptoms are rated as none (0), mild (1), moderate (2), severe (3), very severe (4) scale of the worst severity of the symptom over the last 24 hours.

Secondary Outcomes

Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale(Baseline to 48 weeks post treatment)