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

Northwell Health

Status: Terminated

Conditions: Barretts Esophagus; GERD

Study type: Observational

Funder types: Other

Identifiers

NCT00737802

R01DK059500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

4 participants in 3 patient groups

Normal Control

Description:

Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD

GERD Patients

Description:

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

Description:

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.