Clinical trial NCT00737802: In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter
Official title: In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: GERD
Barretts Esophagus
Keywords: GERD
Heartburn
Esophageal reflux
Barretts esophagus
Normal subjects
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal control subjects without GERD and patients with GERD

Brief summary: 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.

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 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.

Primary outcomes:
measure: Pressure at the gastric sling and clasp fibers
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: LIJ Medical Center- NSLIJ Health System
state: New York
Study officials:
affiliation: Feinstein Institute for Medical Research
name: Larry S Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: