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

Terminated

• Conditions: GERD; Barretts Esophagus

• Registration Number: NCT00737802
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Study Start: 2013-04-12
• Primary Completion: 2015-04-09
• Study Completion: 2017-02-03
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pressure at the gastric sling and clasp fibers	5 years	esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers

Trial Locations

Locations (1)

LIJ Medical Center- NSLIJ Health System; 🇺🇸 New Hyde Park, New York, United States