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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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New York
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New Hyde Park, New York, 미국, 11040
- LIJ Medical Center- NSLIJ Health System
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pressure at the gastric sling and clasp fibers
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Larry S Miller, MD, Feinstein Institute for Medical Research
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .