Clinical trial NCT04869670: A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis
Official title: A Pilot and Feasibility Trial of G-POEM for Gastroparesis to Assess Safety, Physiological Mechanisms and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroparesis
Keywords: Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-05-03
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* Allergy to eggs or Egg Beaters and Ensure.

Primary outcomes:
measure: GCSI-DD change
timeFrame: Baseline to 48 weeks post treatment
Secondary outcomes:
measure: Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale
timeFrame: Baseline to 48 weeks post treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, MD
role: PRINCIPAL_INVESTIGATOR
References: