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Controversy and Clarity in New AGA Gastroparesis Guidelines, With Kyle Staller, MD, MPH
Staller describes unmet needs in gastroparesis and key recommendations for its diagnosis and management from the new AGA guidelines.
Gastroparesis, a chronic disorder of delayed gastric emptying, imposes heavy patient and healthcare burdens. Long hampered by inconsistent diagnoses, limited therapies, and inconclusive data, the field recently gained new guidelines from the American Gastroenterological Association (AGA) aimed at standardizing care while recognizing ongoing evidence gaps.
The document, published in Gastroenterology on September 19, 2025, was developed by an 8-member panel and offers 12 conditional recommendations for the diagnosis and management of the complex gastric motility disorder, including use of 4-hour gastric emptying tests, use of metoclopramide or erythromycin as initial pharmacologic treatment, and shared patient-physician decision making for other treatment recommendations.
“I think part of the unmet need [in gastroparesis], and part of that difficulty, is the fact that it's been really defined by a heterogeneous set of standards,” Kyle Staller, MD, MPH, director of the Gastrointestinal Motility Laboratory at Mass General and first author of the guidelines, told HCPLive. “One of the goals of this guideline was to really present a more homogeneous approach to sort of say who we are talking about when we talk about gastroparesis.”
Staller notes the heterogeneous definition of gastroparesis and subsequent heterogeneous populations seen in clinical trials have led to a lack of success in these trials, stalling therapeutic progress. He also cites controversy regarding whether or not gastroparesis is its own condition or a manifestation of functional dyspepsia.
With a lack of robust evidence across several topics covered in the guidance, Staller explains why the document could not recommend several treatments, including medications and interventions widely relied upon by clinicians. Following clinician, patient, and industry stakeholders voicing concerns that such recommendations might send a message of hopelessness or risk insurance companies withdrawing coverage, the AGA clarified that the document is aimed squarely at clinicians, not payers or policymakers.
Importantly, the guidelines include language emphasizing that while large trials may not show clear benefit, individual patients can still derive meaningful relief from certain therapies.
“We wanted to provide a very careful, very objective evaluation of the existing evidence, and I think all of us are a little disappointed in that the level of evidence that came out, but this should allow you to have a very informed, shared decision making conversation between the clinician and the patient so that you can figure out what priorities each of you may have going forward, and what's the level of evidence underlying those priorities,” Staller said.
Looking ahead, Staller says the field may soon see incremental progress in the form of new data on existing medications and procedures.
“I wouldn't say that there is breaking news coming right away in the field of gastroparesis, but I do think that there are some trials where if this guideline were written when those results come out, it may actually change the level of evidence to push some more things into the ‘suggest for’ type of category,” Staller said.
Editors’ Note: Relevant disclosures for Staller include Focus Medical Communications, Retalsis, Anji, and Ardlix.
