The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Prevalence, Risk Factors and Optimal Biopsy Protocol of Barrett's Esophagus in Taiwan - A Prospective Randomized Study

Conditions
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Barrett's Esophagus, Intestinal Metaplasia

Intervention / Treatment
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* Procedure: One biopsy
* Procedure: Three biopsy
* Procedure: Seattle protocol
* Device: Endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with columnar-lined esophagus Exclusion Criteria: A prior history of endoscopic treatment for Barrett's Esophagus A prior history of upper gastrointestinal malignancy A prior history of total or subtotal gastrectomy Esophageal varices noted during the procedure Uncontrolled coagulopathy Taking antiplatelet drug or anticoagulant

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One biopsy<br>Obtain one biopsy specimen at the proximal part of the the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus | Procedure: One biopsy<br>* To do one biopsy at the proximal part of the longest columnar-lined esophagus.<br>Device: Endoscopy<br>* The participants will receive meticulous endoscopic examination with narrow-band imaging.<br>|
| Active Comparator: Three biopsy<br>Obtain three biopsy specimens at the proximal, middle and distal part of the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus | Procedure: Three biopsy<br>* To do three biopsy at the proximal, middle and distal part of the longest columnar-lined esophagus.<br>Device: Endoscopy<br>* The participants will receive meticulous endoscopic examination with narrow-band imaging.<br>|
| Sham Comparator: Seattle protocol<br>Obtain 4-quadrant biopsy specimens at intervals of every 1 to 2 cm throughout the the columnar-lined esophagus for patients with suspected Barrett's Esophagus | Procedure: Seattle protocol<br>* To do 4-quadrant biopsy every 1-2 cm at the esophagogastric junction. Seattle protocol has been considered as the gold standard biopsy protocol for patients with suspected Barrett's Esophagus.<br>Device: Endoscopy<br>* The participants will receive meticulous endoscopic examination with narrow-band imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The yield rate of intestinal metaplasia | Defined as the proportion of histologic confirmation of goblet cells | Up to 7 days histologic confirmation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The yield rate of dysplasia | Defined as the proportion of histologic confirmation of columnar-lined epithelium with dysplasia | Up to 7 days histologic confirmation | 
| Adverse events | Including bleeding and perforation | From the date of procedure until any events, assessed up to 2 weeks | 
| Procedure time | Defined as from forcep insertion to biopsy complete | From forcep insertion to biopsy complete, assessed up to 1 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's Esophagus, Columnar-lined esophagus, Intestinal metaplasia