Checking pyloric sphincter function in people with gastroparesis symptoms

Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms

We will test whether EndoFLIP, a water‑load satiety test, and a gastric electrical test (Gastric Alimetry) can find pyloric sphincter abnormalities in adults with gastroparesis symptoms compared with people without symptoms.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Johns Hopkins Bloomberg School of Public Health (Academic / other)
• Locations: 5 sites (Scottsdale, Arizona and 4 other locations)
• Trial ID: NCT04661215 on ClinicalTrials.gov

What this trial studies

This multi-center, prospective observational project enrolls adults with gastroparesis symptoms (both delayed and normal gastric emptying) and control participants without symptoms. It uses the FDA-approved EndoFLIP catheter to measure diameter, cross-sectional area, pressure, distensibility, and compliance of the lower esophageal and pyloric sphincters. Symptomatic participants will also undergo a water-load satiety test and gastric myoelectrical recording with the Gastric Alimetry system, while control participants will not receive the Gastric Alimetry testing. Measurements will be compared across symptomatic subgroups and controls to determine the prevalence and characteristics of pyloric abnormalities.

Who should consider this trial

Good fit: Adults aged 18–85 with gastroparesis symptoms (diabetic or idiopathic), a Gastroparesis Cardinal Symptom Index score of at least 2.0, and a 4‑hour gastric emptying study performed within the past 6 months are ideal candidates.

Not a fit: People without gastroparesis symptoms, those younger than 18 or older than 85, or patients who cannot stop excluded medications or complete the tests may not receive direct benefit from participation.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify pyloric problems and better target treatments for people with gastroparesis symptoms.

How similar studies have performed: Prior single-center work using EndoFLIP and pyloric-focused approaches has suggested pyloric dysfunction in some patients with gastroparesis, but combining EndoFLIP with Gastric Alimetry and water-load testing across multiple centers is less established.

Eligibility criteria

Inclusion Criteria FOR SYMPTOMATIC PARTICIPANTS:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 18-85
4. Symptoms of gastroparesis, either diabetic or idiopathic etiology
5. Symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0
6. Individual will have had a prior 4-hour gastric emptying scintigraphy test performed for clinical evaluation within the last 6 months. This gastric emptying test would be done for clinical evaluation and is not part of the research study. From these participants with gastroparesis symptoms, we will include those with delayed gastric emptying as well as those with normal gastric emptying.
7. Participant must not initiate any new treatments until completion of the study procedures.
8. Willingness to:

   1. Stop histamine 2 antagonists, prokinetics (e.g., metoclopramide, erythromycin, domperidone, prucalopride), narcotics, anticholinergics, constipation medications (over the counter laxatives, isotonic polyethylene glycol (PEG) electrolyte preparations (e.g. MiraLax), prescription laxatives (e.g. lubiprostone), proton pump inhibitors, cannabinoids, and cannabidiol (CBD) for 3 days prior to each visit;
   2. Abstain from food and water after midnight (at least for 8 hours) before the start of each visit until after the visit.

INCLUSION CRITERIA FOR CONTROL PARTICIPANTS

1. Provision of signed and dated informed consent form
2. Male or female, aged 18 or older
3. Undergoing an upper endoscopy for their clinical evaluation of diarrhea, GI bleed, or iron-deficiency anemia, or evaluation for bariatric surgery.
4. Do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) of PAGI-SYM questionnaire.

EXCLUSION CRITERIA:

1. Prior gut lumen surgery on the esophagus or the stomach, including Nissen fundoplication.
2. Prior surgery on the pylorus (G-POEM, surgical pyloroplasty, surgical pyloromyotomy)
3. Known history of achalasia or esophageal stricture
4. Known history of physiological or mechanical GI obstruction
5. Abnormalities seen on a prior upper endoscopy placing patient at increased risk:

   * Ulcer of the esophagus, stomach, or duodenum
   * Esophageal varices
6. Individuals at risk for prolonging the endoscopy procedure: severe chronic pulmonary disease, severe food retention in the stomach on endoscopy.
7. Presence of significant gastric or duodenal pathology that could be expected to cause dysmotility (e.g. significant inflammation, infiltrate disorders etc)
8. Individuals with a history of other chronic disease potentially causative of gastrointestinal symptom
9. Acute or chronic renal insufficiency
10. Current eating disorders
11. Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to endoscopic procedures.
12. Individuals with contraindications for endoscopy, including bleeding abnormalities
13. Allergy to eggs preventing sedation with propofol and/or gastric emptying test
14. Significant dysphagia
15. Prior inflammatory bowel disease, Crohn's
16. History of any esophageal/gastric/pyloric injection of botulinum toxin
17. Patients on daily opioid use or \>3 day/week use
18. Use of glucagon-like peptide 1 (GLP1) receptor agonists or Sodium-Glucose Transport Protein 2 (SGLT2); Gastric inhibitory polypeptide (GIP)- glucagon-like peptide (GLP) combo

Where this trial is running

Scottsdale, Arizona and 4 other locations

• Mayo Clinic Arizona — Scottsdale, Arizona, United States (Recruiting)
• University of Louisville — Louisville, Kentucky, United States (Recruiting)
• Massachusetts General — Boston, Massachusetts, United States (Recruiting)
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
• Temple University — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Laura A Miriel, BS

Conditions Gastroparesis; Idiopathic Gastric Motility Disorder; Diabetic Gastroparesis