The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

Trial Title: The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

NCT ID: NCT05818072

Condition: Barrett's Esophagus
Intestinal Metaplasia

Conditions: Official terms:
Barrett Esophagus
Metaplasia

Conditions: Keywords:
Barrett's Esophagus
Columnar-lined esophagus
Intestinal metaplasia

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: Single (Participant)

Intervention:

Intervention type: Procedure
Intervention name: One biopsy
Description: To do one biopsy at the proximal part of the longest columnar-lined esophagus.
Arm group label: One biopsy

Intervention type: Procedure
Intervention name: Three biopsy
Description: To do three biopsy at the proximal, middle and distal part of the longest columnar-lined esophagus.
Arm group label: Three biopsy

Intervention type: Procedure
Intervention name: Seattle protocol
Description: 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.
Arm group label: Seattle protocol

Intervention type: Device
Intervention name: Endoscopy
Description: The participants will receive meticulous endoscopic examination with narrow-band imaging.
Arm group label: One biopsy
Arm group label: Seattle protocol
Arm group label: Three biopsy

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: E-DA Hospital

Address:
City: Kaohsiung City
Zip: 82445
Country: Taiwan

Status: Recruiting

Contact:
Last name: Ying Nan Tsai, M.D

Phone: 886-7-6150011

Phone ext: 252294
Email: littlepig9933@gmail.com

Start date: March 13, 2023

Completion date: December 31, 2026

Lead sponsor:
Agency: E-DA Hospital
Agency class: Other

Source: E-DA Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05818072