Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms

Gastroparesis Clinical Trial

— PSAGS  

Official title:

Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04661215
• Other study ID #: 12 DK PSAGS
• Secondary ID: U24DK074008U01DK
• Status: Not yet recruiting
• Start date: July 30, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Laura A Miriel, BS
• Phone: 410-955-4165
• Email: laura.miriel[@]jhu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overall objective of this study is to determine if there are pyloric sphincter abnormalities in patients with gastroparesis symptoms and determine how prevalent these abnormalities are using tests to assess the pyloric sphincter - endoluminal functional luminal imaging probe (Endoflip™), water load satiety testing (WLST), and high-resolution cutaneous electrogastrography (HR-EGG) using Gastric Alimetry™ System.

Description:

Study Description: This is a multi-center, prospective, observational study to assess pyloric sphincter abnormalities in patients with symptoms of gastroparesis (both delayed and normal gastric emptying) and control participants without symptoms of gastroparesis using the commercially available, FDA approved endoluminal functional luminal imaging probe (Endoflip™) catheter, which measures diameter, cross-sectional area, pressure, compliance, and distensibility of gastrointestinal sphincter muscles.

This study will assess lower esophageal and pyloric sphincter diameter, CSA, pressure, distensibility, and compliance in patients with symptoms of gastroparesis and delayed gastric emptying, patients with symptoms of gastroparesis but with normal gastric emptying, and normal control participants. The protocol will also include a water load satiety test and use Gastric Alimetry™ System that assesses gastric myoelectrical activity in symptomatic participants but not control participants.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 (18/45 x 5)

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

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis
• Idiopathic Gastric Motility Disorder

Locations

Country	Name	City	State
United States	Massachusetts General	Boston	Massachusetts
United States	Texas Tech University Health Science Center (TTUHSC)	El Paso	Texas
United States	University of Louisville	Louisville	Kentucky
United States	Temple University	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (8)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Massachusetts General Hospital, Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Temple University, Texas Tech University Health Sciences Center, El Paso, University of Louisville, Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Desipio J, Friedenberg FK, Korimilli A, Richter JE, Parkman HP, Fisher RS. High-resolution solid-state manometry of the antropyloroduodenal region. Neurogastroenterol Motil. 2007 Mar;19(3):188-95. doi: 10.1111/j.1365-2982.2006.00866.x. — View Citation

Fisher R, Cohen S. Physiological characteristics of the human pyloric sphincter. Gastroenterology. 1973 Jan;64(1):67-75. No abstract available. — View Citation

Mearin F, Camilleri M, Malagelada JR. Pyloric dysfunction in diabetics with recurrent nausea and vomiting. Gastroenterology. 1986 Jun;90(6):1919-25. doi: 10.1016/0016-5085(86)90262-3. — View Citation

Parkman HP, Hasler WL, Fisher RS; American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology. 2004 Nov;127(5):1592-622. doi: 10.1053/j.gastro.2004.09.055. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distensibility of the pylorus	Distensibility of the pylorus will be calculated as the median of three measurements (not three different inflations) of distensibility (mm2/mmHg) of the pylorus pressure using the Endoflip balloon catheter at 50 mL volume	Baseline
Secondary	Opening diameter (mm) of the pylorus when 40 mL volume is introduced into the EF325N Endoflip™ measurement catheter.	diameter (mm) of the pylorus	Baseline
Secondary	Opening diameter (mm) of the pylorus when 50 mL volume is introduced into the EF325N Endoflip™ measurement catheter.	diameter (mm) of the pylorus	Baseline
Secondary	Cross Sectional Area(mm2) of the pylorus with 40 mL balloon volume	Cross Sectional Area (mm2) of the pylorus	Baseline
Secondary	Cross Sectional Area(mm2) of the pylorus with 50 mL balloon volume	Cross Sectional Area (mm2) of the pylorus	Baseline
Secondary	Compliance (mm3/mmHg) of the pylorus with 40 mL balloon volume	Compliance (mm3/mmHg) of the pylorus	Baseline
Secondary	Compliance (mm3/mmHg) of the pylorus with 50 mL balloon volume	Compliance (mm3/mmHg) of the pylorus	Baseline
Secondary	Pressure (mmHg) of the pyloric sphincter	Pressure (mmHg) of the pyloric sphincter	Baseline