- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02632682
Confocal Laser Endomicroscopy vs Conventional Histology for the Identification of Intestinal Metaplasia
Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy With Conventional Histology for the Identification of Specialized Intestinal Metaplasia
연구 개요
상태
정황
상세 설명
The incidence of esophageal adenocarcinoma has risen over 800% over the past several decades and is associated with a high mortality rate. Barrett's esophagus (BE) has been identified as the number one risk factor for the development of esophageal adenocarcinoma. Gastroesophageal reflux disease (GERD) has been identified as the major risk factor for development of BE. Current guidelines for BE diagnosis and surveillance, according to the Seattle protocol, include four-quadrant random biopsies at 2-cm intervals (1-cm intervals if suspected high grade intraepithelial neoplasia). This random biopsy protocol can be time-consuming, expensive, and prone to sampling error, as very little of the esophageal surface area is actually sampled. Probe-based confocal laser endomicroscopy (pCLE) generates optical biopsies, providing physicians with microscopic images of tissue instantaneously and in a minimally invasive manner. Comparing pCLE with conventional histology for the identification of specialized intestinal metaplasia has the potential to result in a new standard of care for the diagnosis of BE. The aim of this study is to compare pCLE to traditional tissue biopsies for the diagnosis of BE.
A patient with GERD will be scheduled for upper endoscopy as part of routine evaluation. Routine endoscopy will be performed, including white light and narrow band imaging photo documentation. Probe-based confocal laser endomicroscopy will be performed at the gastroesophageal junction. Biopsies of columnar lined esophagus will then be taken in four quadrants starting at the squamocolumnar junction and proceeding in 1 cm segments to the gastroesophageal junction. Optical biopsy images will be reviewed immediately following endoscopy by endoscopist and later reviewed by blinded independent reviewer. Pathology specimens will be reviewed by a pathologist. The results of the optical biopsies obtained with probe-based confocal laser endomicroscopy will be compared with the pathology results.
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
- Age >18
- Clinical diagnosis of GERD
- Undergoing upper endoscopy for reflux evaluation
설명
Inclusion Criteria:
- Age >18; Clinical diagnosis of GERD; Undergoing upper endoscopy for reflux evaluation
Exclusion Criteria:
- Age <18, Contraindication to receiving fluorescein, Inability to provide informed consent, History of esophageal ablation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Probe-based confocal laser endomicroscopy (pCLE) will be compared to standard histologic analysis in the evaluation of Barrett's esophagus.
기간: 8 months
|
Metrics for the study will include "positive" or "negative" for Barrett's esophagus.
|
8 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
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. .
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