Barrett's Esophagus, Intestinal Metaplasia
Conditions
Keywords
Barrett's Esophagus, Columnar-lined esophagus, Intestinal metaplasia
Brief 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.
Detailed 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.
Interventions
PROCEDUREOne biopsy
To do one biopsy at the proximal part of the longest columnar-lined esophagus.
PROCEDUREThree biopsy
To do three biopsy at the proximal, middle and distal part of the longest columnar-lined esophagus.
PROCEDURESeattle protocol
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.
DEVICEEndoscopy
The participants will receive meticulous endoscopic examination with narrow-band imaging.
Sponsors
E-DA Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The yield rate of intestinal metaplasia | Up to 7 days histologic confirmation | Defined as the proportion of histologic confirmation of goblet cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The yield rate of dysplasia | Up to 7 days histologic confirmation | Defined as the proportion of histologic confirmation of columnar-lined epithelium with dysplasia |
| Adverse events | From the date of procedure until any events, assessed up to 2 weeks | Including bleeding and perforation |
| Procedure time | From forcep insertion to biopsy complete, assessed up to 1 minutes | Defined as from forcep insertion to biopsy complete |
Countries
Taiwan
Contacts
Primary ContactYing-Nan Tsai, M.D
Backup ContactWen-Lun Wang, Ph.D
Outcome results
None listed