AGA Releases Gastroparesis Clinical Practice Guideline, Highlights Unmet Needs

The American Gastroenterological Association (AGA) has released its clinical practice guideline on the management of gastroparesis, offering 12 conditional recommendations for the diagnosis and management of the complex gastric motility disorder.1,2

Published in Gastroenterology on September 19, 2025, the document was developed to provide recommendations for ensuring an accurate diagnosis and identifying evidence-based, effective treatments among the available pharmacologic and procedural interventions for patients with idiopathic gastroparesis or gastroparesis related to diabetes.1

“We intend these recommendations to be used by clinicians to guide the management of patients and inform considerations of benefits and harms of treatments in each individual case, rather than providing a specific standard to adhere to,” Kyle Staller, MD, MPH, a gastroenterologist and the director of the Gastrointestinal Motility Laboratory at Mass General, and colleagues wrote.1 “In this way, the guideline and its recommendations are intended to contribute to the improved delivery and management of GI health care services.”

The guideline was developed was developed by an 8-member panel comprising 6 clinical/content experts with clinical and/or research expertise in gastroparesis and 2 methodologists with specialized Grading of Recommendations Assessment, Development and Evaluation (GRADE) guideline development skills. It underwent several levels of review, including an open, 30-day public comment period, external peer review by known topic experts, and patient review. Organizational-level review was also carried out by the AGA Institute’s Clinical Guidelines Committee and Governing Board.1

Ultimately, the Guideline Panel agreed on 12 recommendations. In individuals with suspected gastroparesis, the AGA issued a conditional recommendation against the use of a 2-hour or shorter gastric emptying study compared with a 4-hour gastric emptying study to evaluate for delayed gastric emptying, citing high rates of false-negative and false-positive results with a shorter test.1

In individuals with gastroparesis, the AGA conditionally recommends using metoclopramide and erythromycin. The metoclopramide recommendation was made based on findings from 7 clinical trials comparing the use of metoclopramide with placebo in individuals with gastroparesis, which demonstrated significant reductions in major symptoms like nausea, vomiting, early satiety, and postprandial fullness, as well as reductions in symptom severity score. However, the panel notes potential adverse effects of metoclopramide should be discussed with patients before starting treatment, citing an FDA black box warning regarding the risk of tardive dyskinesia with metoclopramide.1

In the absence of well-designed placebo-controlled RCTs studying the effect of erythromycin on symptoms of gastroparesis, the erythromycin recommendation was based on findings from a trial comparing the use of erythromycin with metoclopramide and 7 trials comparing the use of metoclopramide with placebo in individuals with gastroparesis, which demonstrated reductions in GCSI-DD with few safety concerns. However, the FDA package for erythromycin has warnings regarding hepatotoxicity, QT segment prolongation, and drug interactions due to inhibition of Cytochrome P450 3A4.1

In the guideline, the AGA issued conditional recommendations against the use of domperidone, prucalopride, aprepitant, nortriptyline, buspirone, and cannabidiol as first-line therapies for gastroparesis.1

In addition, conditional recommendations were issued against the routine initial use of gastric peroral endoscopic pyloromyotomy (G-POEM) or gastric electrical stimulation in patients with gastroparesis, reserving these treatments for select patients with symptoms refractory to medical therapies. The panel notes candidates for G-POEM should have had a diagnosis of gastroparesis with an appropriately done 4-hour gastric emptying study, generally with at least a moderate delay in gastric emptying, as well as 6–12 months of moderate symptoms with the cardinal symptoms of nausea, vomiting, and/or postprandial fullness.1

The AGA did not give any recommendation regarding the use of surgical pyloromyotomy and surgical pyloroplasty, citing insufficient high-quality evidence to support a recommendation for or against their routine use in clinical practice. Instead, the panel calls for further research, including sham-controlled RCTs evaluating surgical pyloric interventions in patients with gastroparesis, head-to-head clinical trials comparing surgical pyloric interventions with endoscopic pyloric interventions in patients with refractory gastroparesis, prospective studies exploring the role of GES in combination with surgical pyloric interventions, and research about subgroups of patients who will benefit from surgical pyloric interventions.1

“Overall, there is still considerable unmet need in the treatment of gastroparesis, and carefully performed randomized trials to evaluate efficacy of treatments are necessary,” investigators concluded.1

References

1. Staller K, Parkman HP, Greer KB, et al. AGA Clinical Practice Guideline on Management of Gastroparesis. Gastroenterology. doi:10.1053/j.gastro.2025.08.004

2. AGA. New guideline emphasizes personalized gastroparesis care. September 19, 2025. Accessed September 19, 2025. https://gastro.org/news/new-guideline-emphasizes-personalized-gastroparesis-care/