# Per-Oral Pyloromyotomy (POP) in the treatment of medical refractory gastroparesis : A randomized, sham-controlled trial

> **NIH NIH R01** · CLEVELAND CLINIC LERNER COM-CWRU · 2022 · $251,098

## Abstract

PROJECT SUMMARY/ABSTRACT:
Gastroparesis is a chronic, debilitating functional disorder of the stomach characterized by a
delay in gastric emptying without evidence of mechanical obstruction. Classic etiologies of
gastroparesis include idiopathic, post-surgical/iatrogenic, and diabetic. The incidence of
gastroparesis is rapidly increasing coinciding with the diabetes epidemic in developed countries.
Initial management of gastroparesis includes dietary modifications and prokinetic and/or
antiemetic medications; however, these tend to lose efficacy over time and are often associated
with intolerable side effects. Surgical therapy for gastroparesis is typically pursued once
maximal medical therapy is no longer efficacious and may include gastric electrical stimulation,
gastric bypass or subtotal gastrectomy in most cases. Disruption of the gastric pyloric sphincter
(pyloroplasty, pyloromyotomy) has recently shown promise as a stomach-preserving option that
does not involve the significant anatomical rearrangement required of gastrectomy. Per-oral
pyloromyotomy (POP) is a novel endoscopic surgery that has shown promising utility for the
management of medically refractory gastroparesis in several small single center studies. This
intervention involves the division of the gastric pylorus via an endoscopic approach,
accomplishing the same functional outcome of laparoscopic or open pyloromyotomy, without the
invasiveness of open or laparoscopic surgery. Prior non-comparative retrospective studies have
demonstrated both improvement of gastroparesis symptoms and improved gastric emptying. To
date, there have been no prospective studies evaluating the efficacy of this procedure or
comparisons to a control procedure. We aim to explore the utility of POP in producing
symptomatic relief of gastroparesis-related symptoms as evaluated by validated scoring
systems (Objective 1) and objective gastric emptying as measured by solid-phase scintigraphic
gastric emptying studies (Objective 2). The proposed research is innovative in that it would
additionally control for the placebo effect by blinding patients to receiving POP versus a sham
intervention. This contribution would be significant as traditional gastroparesis therapies do not
adequately address the clinical need, and supports the mission of the NIDDK to assess new
therapeutic options in clinical trials. POP represents a potential intervention with far greater
safety profile and less morbidity compared to other surgical modalities.

## Key facts

- **NIH application ID:** 10390490
- **Project number:** 5R01DK120830-03
- **Recipient organization:** CLEVELAND CLINIC LERNER COM-CWRU
- **Principal Investigator:** Matthew Thomas Allemang
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $251,098
- **Award type:** 5
- **Project period:** 2020-07-15 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10390490

## Citation

> US National Institutes of Health, RePORTER application 10390490, Per-Oral Pyloromyotomy (POP) in the treatment of medical refractory gastroparesis : A randomized, sham-controlled trial (5R01DK120830-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10390490. Licensed CC0.

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