A Study To Evaluate Safety And Effectiveness Of G-POEM For Gastroparesis

Overview

About this study

The primary aim of this pilot and feasibility, hypothesis-generating study therefore is to evaluate the effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham endoscopic surgery on symptoms in patients with diabetic or idiopathic gastroparesis.

Gastroparesis is a disorder of gastric function characterized by delay in gastric emptying, frequently associated with chronic nausea and vomiting, early satiety, postprandial fullness, abdominal pain, and malnutrition that may require nutritional support. There are few effective treatments available; more recently, a procedure called G-POEM (gastric peroral endoscopic myotomy) has been advocated to relieve symptoms by improving gastric emptying; however, it is not clear whether this is safe or effective.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female, ages 18-70 years.
  • 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 with mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 2.3.
  • Refractory gastroparesis, defined using our previously published data5, as a failure to improve by at least 1 point on the GCSI scale 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. Gastric emptying scintigraphy will be performed within 6 months of registration.
  • No evidence of mechanical obstruction based on upper GI endoscopy or barium series within 2 years of registration.

Exclusion Criteria:

  • Another active disorder which could explain symptoms in the opinion of the investigator.
  • Gastric retention of solids at 4 hours < 25%.
  • Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) or drugs that slow down gastric emptying (tricyclic antidepressants, anti-cholinergic agents and narcotics).
  • Significant systemic illness such as chronic renal failure 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Pankaj Pasricha, M.B.B.S., M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Guillermo Barahona Hernandez

(410) 603-8343

barahona.guillermo@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D., D.Sc.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Deborah Eckert

5075385860

eckert.deborah@mayo.edu

More information

Publications

Publications are currently not available