In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter
| Status: | Terminated |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/24/2019 |
| Start Date: | April 12, 2013 |
| End Date: | February 3, 2017 |
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.
- 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.
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.
(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.
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.
We found this trial at
1
site
New Hyde Park, New York 11040
Principal Investigator: Larry Miller, M.D.
Phone: 718-470-4691
Click here to add this to my saved trials
