In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter|
- Pressure at the gastric sling and clasp fibers [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD
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 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737802
|Contact: Larry S Miller, M.D.||firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Larry Miller, M.D.|
|Principal Investigator:||Larry S Miller, MD||Feinstein Institute for Medical Research|