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Trial record 1 of 1 for:    PSAGS
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Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms (PSAGS)

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ClinicalTrials.gov Identifier: NCT04661215
Recruitment Status : Not yet recruiting
First Posted : December 10, 2020
Last Update Posted : May 9, 2024
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Massachusetts General Hospital
Temple University
University of Louisville
Wake Forest University
Texas Tech University Health Sciences Center, El Paso
Mayo Clinic
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Description
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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.

Condition or disease
Gastroparesis Idiopathic Gastric Motility Disorder Diabetic Gastroparesis

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
Estimated Study Start Date : July 30, 2024
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Symptoms of gastroparesis
Participants with symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0 (18/45 x 5)
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


Outcome Measures
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Primary Outcome Measures :
  1. Distensibility of the pylorus [ Time Frame: Baseline ]
    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


Secondary Outcome Measures :
  1. Opening diameter (mm) of the pylorus when 40 mL volume is introduced into the EF325N Endoflip™ measurement catheter. [ Time Frame: Baseline ]
    diameter (mm) of the pylorus

  2. Opening diameter (mm) of the pylorus when 50 mL volume is introduced into the EF325N Endoflip™ measurement catheter. [ Time Frame: Baseline ]
    diameter (mm) of the pylorus

  3. Cross Sectional Area(mm2) of the pylorus with 40 mL balloon volume [ Time Frame: Baseline ]
    Cross Sectional Area (mm2) of the pylorus

  4. Cross Sectional Area(mm2) of the pylorus with 50 mL balloon volume [ Time Frame: Baseline ]
    Cross Sectional Area (mm2) of the pylorus

  5. Compliance (mm3/mmHg) of the pylorus with 40 mL balloon volume [ Time Frame: Baseline ]
    Compliance (mm3/mmHg) of the pylorus

  6. Compliance (mm3/mmHg) of the pylorus with 50 mL balloon volume [ Time Frame: Baseline ]
    Compliance (mm3/mmHg) of the pylorus

  7. Pressure (mmHg) of the pyloric sphincter [ Time Frame: Baseline ]
    Pressure (mmHg) of the pyloric sphincter


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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 (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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661215


Contacts
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Contact: Laura A Miriel, BS 410-955-4165 laura.miriel@jhu.edu
Contact: Emily Mitchell, MS, MBA esharke5@jhu.edu

Locations
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United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Contact: Guillermo Barahona, PhD       Barahona.Guillermo@mayo.edu   
Contact       Pasricha.Jay@mayo.edu   
Principal Investigator: Jay Paricha, MD         
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General
Boston, Massachusetts, United States, 02114
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Contact: Baha Moshiree, MD    704-355-4593    Baha.Moshiree@atriumhealth.org   
Principal Investigator: Baha Moshiree, MD         
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Contact: Rona T Cooper    215-707-5477    rona.taylor@temple.edu   
Principal Investigator: Henry P Parkman, MD         
United States, Texas
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Massachusetts General Hospital
Temple University
University of Louisville
Wake Forest University
Texas Tech University Health Sciences Center, El Paso
Mayo Clinic
Investigators
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Study Chair: Pankaj Pasricha, MD Mayo Clinic
Study Chair: Henry Parkman, MD Temple University
More Information
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Publications:

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT04661215    
Other Study ID Numbers: 12 DK PSAGS
U24DK074008 ( U.S. NIH Grant/Contract )
U01DK073974 ( U.S. NIH Grant/Contract )
U01DK074007 ( U.S. NIH Grant/Contract )
U01DK074035 ( U.S. NIH Grant/Contract )
U01DK073975 ( U.S. NIH Grant/Contract )
U01DK112193 ( U.S. NIH Grant/Contract )
U01DK073983 ( U.S. NIH Grant/Contract )
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Public use complete database will be submitted to the NIDDK Data Repository
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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
URL: https://repository.niddk.nih.gov/home/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Paralysis
Neurologic Manifestations