The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

May 9, 2023 updated by: E-DA Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 82445
        • Recruiting
        • E-DA Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One biopsy
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
To do one biopsy at the proximal part of the longest columnar-lined esophagus.
Device: Endoscopy
The participants will receive meticulous endoscopic examination with narrow-band imaging.
Active Comparator: Three biopsy
Obtain three biopsy specimens at the proximal, middle and distal part of the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus
Device: Endoscopy
The participants will receive meticulous endoscopic examination with narrow-band imaging.
Procedure: Three biopsy
To do three biopsy at the proximal, middle and distal part of the longest columnar-lined esophagus.
Sham Comparator: Seattle protocol
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
Device: Endoscopy
The participants will receive meticulous endoscopic examination with narrow-band imaging.
Procedure: Seattle 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

E-DA Hospital

Investigators

  • Study Chair: Ying Nan Tsai, MD, Division of Gastroenterology and Hepatology, E-Da Cancer Hospital, Kaohsiung, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

March 5, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDAHS-111031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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