Clinical Trials Logo

Clinical Trial Summary

Detections of goblet cells and dysplasia are crucial for diagnosis and determining the surveillance program of Barrett's esophagus (BE). However, the optimal biopsy numbers and their yield rates of intestinal metaplasia (IM) and dysplasia are still uncertain, especially in Asia. The aim of this study was to determine the optimal biopsy protocol of BE.


Clinical Trial Description

Barrett's esophagus (BE) is premalignant lesion for esophageal adenocarcinoma (EAC) and defined as the distal esophageal squamous epithelium replaced by columnar epithelium with histologic confirmation of intestinal metaplasia (IM). The accurate prevalence of BE is difficult to assess because part of people with BE are asymptomatic. However, the prevalence of gastroesophageal reflux disease (GERD) which is the main factor associated with BE has increased almost 50% during the last 20 years. Meanwhile, the general population prevalence of BE is estimated to increase to 3-10% in Western countries. The systematic review and meta-analysis also reported an upward trend in prevalence of BE in Asian countries. BE is an important heathy issue to investigate in either Western or Asian countries. The annual rate of developing esophageal adenocarcinoma is around 0.2% to 0.5% in patients with BE. However, the annual adenocarcinoma progression risk is different between the non-dysplastic Barrett's esophagus (NDBE), BE with low-grade dysplasia (LGD) and high-grade dysplasia (HGD). The annual incidence of esophageal adenocarcinoma is 0.33%, 0.54% and 6.58% in patients with NDBE, BE with LGD and HGD, respectively. Among patients with NDBE, patients with short segment BE (SSBE) have the lower rate of progression to EAC than those who with long segment BE (LSBE) (0.07% vs 0.25%). Therefore, endoscopic surveillance of patients with BE is recommended by clinical practice guideline. Detections of goblet cells and dysplasia are crucial for diagnosis and determining the surveillance program of BE. According to the Seattle protocol which has been widely recommended by clinical practice guidelines, biopsy specimens should be obtained every one cm to two cm interval across the four quadrants of the columnar epithelium of esophagus. Fewer endoscopists adhered to this protocol in clinical practice because of its laboriousness and time consumption. Most of patients with BE were categorized as SSBE and SSBE seems to be more prevalent in Asian populations. As the report of previous study which reviewed the general prevalence of BE in Western and Asian general populations, the ratio of SSBE to LSBE was ranging from 1.8 to 17.4 in the Western countries and 1.7 to 103 in the Asian countries. It's more difficult to adhere to the protocol in patients with SSBE. However, the optimal biopsy numbers and their yield rates of IM and dysplasia are still uncertain, especially in Asia. The investigators aimed to assess the biopsy numbers and yield rates of IM and dysplasia in patients with columnar-lined esophagus (CLE) to determine the optimal biopsy protocol. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05818072
Study type Interventional
Source E-DA Hospital
Contact Ying-Nan Tsai, M.D
Phone 886-7-6150011
Email littlepig9933@gmail.com
Status Recruiting
Phase N/A
Start date March 13, 2023
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02864043 - Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System N/A
Recruiting NCT02018367 - Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma Phase 2
Terminated NCT01572987 - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus N/A
Terminated NCT01976351 - Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus N/A
Terminated NCT00526786 - Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus Phase 4
Completed NCT01401699 - Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction N/A
Completed NCT02106910 - Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy N/A
Suspended NCT01580631 - Narrow Band Imaging Project on Barrett's Esophagus
Completed NCT01439633 - Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus N/A
Completed NCT02879721 - Expression and Function of the Renin-Angiotensin System in the Esophagus Phase 0
Completed NCT01439594 - Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation N/A
Completed NCT01281618 - Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus N/A
Completed NCT00586872 - Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Completed NCT00844077 - Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus N/A
Completed NCT00588575 - Ramanspectroscopy in Barrett's Esophagus
Recruiting NCT00288119 - Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Completed NCT03813381 - CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO). N/A
Completed NCT02579460 - Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition N/A
Not yet recruiting NCT02033070 - Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System N/A
Completed NCT01961778 - Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma N/A