Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms

NCT04661215 | Recruiting DMC

• 8 other identifiers: 12 DK PSAGSU24DK074008U01DK073974U01DK074007U01DK074035U01DK073975U01DK112193U01DK073983
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Gastroparesis; Idiopathic Gastric Motility Disorder; Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Opening diameter (mm) of the pylorus when 40 mL volume is introduced into the EF325N Endoflip™ measurement catheter.

  Baseline

• Opening diameter (mm) of the pylorus when 50 mL volume is introduced into the EF325N Endoflip™ measurement catheter.

  Baseline

• Cross Sectional Area(mm2) of the pylorus with 40 mL balloon volume

  Baseline

• Cross Sectional Area(mm2) of the pylorus with 50 mL balloon volume

  Baseline

• Compliance (mm3/mmHg) of the pylorus with 40 mL balloon volume

  Baseline

Study Arms (2)

Symptoms of gastroparesis

Participants with symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0

Control participants

Participants undergoing endoscopy for evaluation but without gastroparesis symptoms or gastroesophageal reflux symptoms. Score 1.0 or less (≤ 1 ) on the GCSI of Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) questionnaire

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be 150 adult men and women aged 18-85 years, located in the United States, 100 will have symptoms of gastroparesis, and 50 participants in the control group will be patients undergoing upper endoscopy for clinical evaluation of diarrhea, gastrointestinal (GI) bleed, or iron-deficiency anemia, or evaluation for bariatric surgery who do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) . Control group participants will not have Gastric Alimetry testing or water load satiety testing.

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 18-85
• Symptoms of gastroparesis, either diabetic or idiopathic etiology
• Symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0
• 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.
• Participant must not initiate any new treatments until completion of the study procedures.
• Willingness to:
• 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;
• Abstain from food and water after midnight (at least for 8 hours) before the start of each visit until after the visit.
• Provision of signed and dated informed consent form
• Male or female, aged 18 or older
• Undergoing an upper endoscopy for their clinical evaluation of diarrhea, GI bleed, or iron-deficiency anemia, or evaluation for bariatric surgery.
• Do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) of PAGI-SYM questionnaire.

You may not qualify if:

• Prior gut lumen surgery on the esophagus or the stomach, including Nissen fundoplication.
• Prior surgery on the pylorus (G-POEM, surgical pyloroplasty, surgical pyloromyotomy)
• Known history of achalasia or esophageal stricture
• Known history of physiological or mechanical GI obstruction
• Abnormalities seen on a prior upper endoscopy placing patient at increased risk:
• Ulcer of the esophagus, stomach, or duodenum
• Esophageal varices
• Individuals at risk for prolonging the endoscopy procedure: severe chronic pulmonary disease, severe food retention in the stomach on endoscopy.
• Presence of significant gastric or duodenal pathology that could be expected to cause dysmotility (e.g. significant inflammation, infiltrate disorders etc)
• Individuals with a history of other chronic disease potentially causative of gastrointestinal symptom
• Acute or chronic renal insufficiency
• Current eating disorders
• Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to endoscopic procedures.
• Individuals with contraindications for endoscopy, including bleeding abnormalities
• Allergy to eggs preventing sedation with propofol and/or gastric emptying test

Sponsors & Collaborators

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

Study Sites (6)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

NOT YET RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Massachusetts General

Boston, Massachusetts, 02114, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Texas Tech University Health Science Center (TTUHSC)

El Paso, Texas, 79905, United States

NOT YET RECRUITING

Related Publications (4)

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

  PMID: 4683856 BACKGROUND

• 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.

  PMID: 15521026 BACKGROUND

• 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.

  PMID: 17300288 BACKGROUND

• 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.

  PMID: 3699409 BACKGROUND

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pankaj Pasricha, MD

  Mayo Clinic

  STUDY CHAIR

• Henry Parkman, MD

  Temple University

  STUDY CHAIR

Central Study Contacts

Laura A Miriel, BS

CONTACT

410-955-4165; laura.miriel@jhu.edu

Emily Mitchell, MS, MBA

CONTACT

esharke5@jhu.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: January 13, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: By the end of the funding period
• Access Criteria: Application through National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository; Institutional Review Board (IRB) approval

Locations

US (6)