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

NCT ID: NCT00737802

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-12
• Study Completion Date: 2017-02-03

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.

Conditions

GERD; Barretts Esophagus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal Control

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

No interventions assigned to this group

GERD Patients

GERD patients are those with history of GERD, signs and symptoms of GERD and selected signs and symptoms of GERD in the questionnaire.

No interventions assigned to this group

Barrett's patients

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Symptomatic heartburn
• Regurgitation
• Chest pain or water brash

Exclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Larry Miller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larry S Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Feinstein Institute for Medical Research

Locations

LIJ Medical Center- NSLIJ Health System

New Hyde Park, New York, United States

Countries

United States

Other Identifiers

R01DK059500

Identifier Type: NIH

Identifier Source: org_study_id

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