In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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New York
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New Hyde Park, New York, États-Unis, 11040
- LIJ Medical Center- NSLIJ Health System
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Normal Control
Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD
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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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pressure at the gastric sling and clasp fibers
Délai: 5 years
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esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers
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5 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Larry S Miller, MD, Feinstein Institute for Medical Research
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01DK059500 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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