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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00737802

Enrollment

Registered

2008-08-20

Start date

2013-04-12

Completion date

2017-02-03

Last updated

2019-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barretts Esophagus, GERD

Keywords

GERD, Heartburn, Esophageal reflux, Barretts esophagus, Normal subjects

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

Inclusion criteria for GERD patients are: * Symptomatic heartburn * Regurgitation * Chest pain or water brash

Design outcomes

Primary

Measure	Time frame	Description
Pressure at the gastric sling and clasp fibers	5 years	esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers

Countries

United States

Outcome results