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The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

Primary Purpose

Barrett's Esophagus, Intestinal Metaplasia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
One biopsy
Three biopsy
Seattle protocol
Endoscopy
Sponsored by
E-DA Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Barrett's Esophagus focused on measuring Barrett's Esophagus, Columnar-lined esophagus, Intestinal metaplasia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • E-DA HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

One biopsy

Three biopsy

Seattle protocol

Arm Description

Obtain one biopsy specimen at the proximal part of the the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus

Obtain three biopsy specimens at the proximal, middle and distal part of the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus

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

Outcomes

Primary Outcome Measures

The yield rate of intestinal metaplasia
Defined as the proportion of histologic confirmation of goblet cells

Secondary Outcome Measures

The yield rate of dysplasia
Defined as the proportion of histologic confirmation of columnar-lined epithelium with dysplasia
Adverse events
Including bleeding and perforation
Procedure time
Defined as from forcep insertion to biopsy complete

Full Information

First Posted
March 5, 2023
Last Updated
May 9, 2023
Sponsor
E-DA Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05818072
Brief Title
The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE
Official Title
The Prevalence, Risk Factors and Optimal Biopsy Protocol of Barrett's Esophagus in Taiwan - A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
E-DA Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus, Intestinal Metaplasia
Keywords
Barrett's Esophagus, Columnar-lined esophagus, Intestinal metaplasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One biopsy
Arm Type
Experimental
Arm Description
Obtain one biopsy specimen at the proximal part of the the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus
Arm Title
Three biopsy
Arm Type
Active Comparator
Arm Description
Obtain three biopsy specimens at the proximal, middle and distal part of the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus
Arm Title
Seattle protocol
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
One biopsy
Intervention Description
To do one biopsy at the proximal part of the longest columnar-lined esophagus.
Intervention Type
Procedure
Intervention Name(s)
Three biopsy
Intervention Description
To do three biopsy at the proximal, middle and distal part of the longest columnar-lined esophagus.
Intervention Type
Procedure
Intervention Name(s)
Seattle protocol
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Endoscopy
Intervention Description
The participants will receive meticulous endoscopic examination with narrow-band imaging.
Primary Outcome Measure Information:
Title
The yield rate of intestinal metaplasia
Description
Defined as the proportion of histologic confirmation of goblet cells
Time Frame
Up to 7 days histologic confirmation
Secondary Outcome Measure Information:
Title
The yield rate of dysplasia
Description
Defined as the proportion of histologic confirmation of columnar-lined epithelium with dysplasia
Time Frame
Up to 7 days histologic confirmation
Title
Adverse events
Description
Including bleeding and perforation
Time Frame
From the date of procedure until any events, assessed up to 2 weeks
Title
Procedure time
Description
Defined as from forcep insertion to biopsy complete
Time Frame
From forcep insertion to biopsy complete, assessed up to 1 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying-Nan Tsai, M.D
Phone
886-7-6150011
Ext
252294
Email
littlepig9933@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Lun Wang, Ph.D
Phone
886-7-6150011
Ext
251346
Email
warrengodr@gmail.com
Facility Information:
Facility Name
E-DA Hospital
City
Kaohsiung City
ZIP/Postal Code
82445
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Nan Tsai, M.D
Phone
886-7-6150011
Ext
252294
Email
littlepig9933@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Learn more about this trial

The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

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