# A randomized control trial of G-POEM for gastroparesis to assess feasibility, safety, efficacy and physiological mechanisms

> **NIH NIH R01** · JOHNS HOPKINS UNIVERSITY · 2022 · $593,950

## Abstract

ABSTRACT
 Gastroparesis is defined as a gastrointestinal motility disorder with objectively delayed gastric emptying of
solids in the absence of mechanical obstruction, associated with upper gastrointestinal symptoms including
early satiety, postprandial fullness, nausea, vomiting, bloating, and upper abdominal pain. The
pathophysiology of gastroparesis includes postprandial antral hypomotility and pylorospasm, which may reflect
extrinsic (vagal) denervation, enteric (intrinsic) neuropathy involving excitatory or inhibitory neurons or
electrical syncytium (such as interstitial cells of Cajal) which may result from imbalance of CD206-positive
macrophages that protect these intrinsic mechanisms. The introduction of G-POEM involving endoscopic
pyloromyotomy has focused attention on pyloric dysfunction as a potentially important factor in the
pathogenesis of this syndrome. However, many unknowns remain. First, the reported trials are uncontrolled
with results that are short-term and inconsistent so the true efficacy of this procedure is not clear. Second,
given that it is unlikely that G-POEM is a panacea for all patients, it is important to determine which of several
possible factors influence outcome e.g. etiology (specifically diabetic versus idiopathic gastroparesis);
demographic factors (age, BMI, psychological factors, duration of illness), baseline severity of gastric retention;
gastric dysrhythmia, pyloric distensibility or scarring (as measured by EndoFLIP), postprandial antral motility
and “isolated” pylorospasm (tonic elevation of baseline pressure independent of antral contractions).
Our general hypothesis is that G-POEM is efficacious in relieving some or all symptoms of gastroparesis and
that efficacy differs according to diagnosis, baseline retardation of gastric emptying, antropyloroduodenal
motility and pyloric sphincter diameter and compliance. We will examine this hypothesis in a controlled short-
term study that will inform future, more definitive trials on G-POEM on the optimal patient selection and
outcome criteria. The aims of this pilot and feasibility, hypothesis-generating study are:
Aim 1: To evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham
surgery in patients with drug-refractory gastroparesis, as measured by validated questionnaires and to perform
a pilot analysis of factors predictive of the outcome including demographics, etiology, vagal dysfunction, in vivo
gastric physiology, (emptying of solids, postprandial antral motility, gastric dysrhythmia and pyloric motor
functions).
Aim 2. To compare the long-term (1 year or more) outcomes in patients randomized to G-POEM with matched
patients prospectively followed in the national Gastroparesis registry run by the Gastroparesis Clinical
Research Consortium (GpCRC).
.

## Key facts

- **NIH application ID:** 10416023
- **Project number:** 5R01DK125680-02
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** MICHAEL L. CAMILLERI
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $593,950
- **Award type:** 5
- **Project period:** 2021-06-15 → 2022-10-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10416023

## Citation

> US National Institutes of Health, RePORTER application 10416023, A randomized control trial of G-POEM for gastroparesis to assess feasibility, safety, efficacy and physiological mechanisms (5R01DK125680-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10416023. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*