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NCT Number: NCT05818072

The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

E-DA Hospital

Kaohsiung City, 82445, Taiwan

Location status: Recruiting

Location contact

Ying Nan Tsai, M.D

CONTACT

[email protected]

886-7-6150011 ext. 252294

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One biopsy

Procedure

To do one biopsy at the proximal part of the longest columnar-lined esophagus.

Three biopsy

Procedure

To do three biopsy at the proximal, middle and distal part of the longest columnar-lined esophagus.

Seattle protocol

Procedure

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.

Endoscopy

Device

The participants will receive meticulous endoscopic examination with narrow-band imaging.

Primary outcomes

  1. The yield rate of intestinal metaplasia

    Time frame: Up to 7 days histologic confirmation

    Defined as the proportion of histologic confirmation of goblet cells

Secondary outcomes

  1. 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

  2. Adverse events

    Time frame: From the date of procedure until any events, assessed up to 2 weeks

    Including bleeding and perforation

  3. Procedure time

    Time frame: From forcep insertion to biopsy complete, assessed up to 1 minutes

    Defined as from forcep insertion to biopsy complete

Study contacts

Contact information is provided by the study sponsor or research team.

Wen-Lun Wang, Ph.D

CONTACT

[email protected]

886-7-6150011 ext. 251346

Ying-Nan Tsai, M.D

CONTACT

[email protected]

886-7-6150011 ext. 252294

Sponsors and collaborators

Lead sponsor

E-DA Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 18, 2023
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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