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In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter

This study is currently recruiting participants.
Verified September 2017 by Larry Miller, Northwell Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737802
First Posted: August 20, 2008
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Larry Miller, Northwell Health
  Purpose

The purpose of this study is:

  • To study the components of the gastroesophageal junction high-pressure zone individually and as a group, by pharmacologically eliminating or accentuating the pressure profile generated by the smooth muscle components.
  • To differentiate the gastric sling fibers from the clasp fibers based on the spatial orientation of these muscle groups.

Condition
GERD Barretts Esophagus

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter

Resource links provided by NLM:


Further study details as provided by Larry Miller, Northwell Health:

Primary Outcome Measures:
  • Pressure at the gastric sling and clasp fibers [ Time Frame: 5 years ]
    esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers


Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal Control
Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD
GERD Patients
GERD patients are those with history of GERD, signs and symptoms of GERD and selected signs and symptoms of GERD in the questionnaire.
Barrett's patients
Barrett's patients are those participants who in addition to all the qualities of GERD patients have long standing history of GERD and mucosal changes in the esophagus.

Detailed Description:

The purpose of this research study is to examine and evaluate a part of the digestive system (gastrointestinal tract). The specific part the study team will look at is called the "lower esophageal sphincter complex." This complex is located where the esophagus (food pipe) meets the top of the stomach. The lower esophageal sphincter complex involves a group of muscles, and the study team hopes to better understand how they work.

The study team hopes that, by studying the lower esophageal sphincter complex, it may be possible to discover how it functions and what causes it to fail. When a complex fails, this can lead to reflux and heartburn. So learning more about the lower esophageal complex may help doctors' better treat future patients with reflux problems.

We plan to study these functions in normal control subjects, in patients with GERD (heartburn symptoms), and in patients with Barrett's esophagus (a change in the lining of the esophagus due to chronic reflux). The doctor performing the study procedure has previous experience with and is skilled in performing these procedures.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal control subjects without GERD and patients with GERD
Criteria

Inclusion Criteria:

Inclusion criteria for GERD patients are:

  • Symptomatic heartburn
  • Regurgitation
  • Chest pain or water brash

Exclusion Criteria:

Exclusion criteria for normal volunteers include:

  • Medications-Subjects on any medication which could effect the gastroesophageal junction high-pressure zone will be excluded, this includes use of antacids, H2 blockers, proton pump inhibitors, prokinetic agents, erythromycin type antibiotics and anticholinergics.
  • GI symptoms, conditions and disorders

In addition exclusion criteria will include a history of:

  • Esophagitis
  • Gastrointestinal symptoms such as abdominal pain
  • Heartburn
  • Reflux
  • Regurgitation
  • Chest pain
  • Difficulty swallowing
  • Pain on swallowing
  • Dysphagia
  • Abdominal surgery involving the stomach or esophagus
  • Nausea or vomiting
  • Diabetes
  • Scleroderma
  • Esophageal motility disorders
  • Non cardiac chest pain
  • Achalasia and current pregnancy.
  Contacts and Locations
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): NCT00737802


Contacts
Contact: Larry S Miller, M.D. 718-470-4691 lmiller7@nshs.edu

Locations
United States, New York
LIJ Medical Center- NSLIJ Health System Recruiting
New Hyde Park, New York, United States, 11040
Contact: Larry Miller, M.D.    718-470-4691    lmiller7@northwell.edu   
Principal Investigator: Larry Miller, M.D.         
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Larry S Miller, MD Feinstein Institute for Medical Research
  More Information

Responsible Party: Larry Miller, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT00737802     History of Changes
Other Study ID Numbers: R01DK059500 ( U.S. NIH Grant/Contract )
First Submitted: August 18, 2008
First Posted: August 20, 2008
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Larry Miller, Northwell Health:
GERD
Heartburn
Esophageal reflux
Barretts esophagus
Normal subjects

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases