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Endoscopic Biopsy Techniques in Barrett's Esophagus Patients

NCT05578677 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-04-17

No results posted yet for this study

Summary

Barrett's esophagus (BE) is a premalignant condition of the distal esophagus, predisposing to dysplasia and esophageal adenocarcinoma. Therefore, in BE patients, current guidelines recommend endoscopic surveillance with four-quadrant biopsies every 2 centimeters of the Barrett's length. These biopsies need to be of optimal quality for adequate histopathological assessment. Larger biopsies can facilitate adequate histopathological assessment because (1) more tissue is available, (2) larger biopsies usually result in less superficial biopsies, with all mucosal layers present in the biopsy specimen, and (3) larger biopsies will ease orientation of the specimen. In a pilot study, the investigators found a median increase of nearly 30% in surface area when the biopsies were obtained by BE-expert endoscopists in comparison with non BE-expert endoscopists. A possible explanation for this difference can be biopsy method or technique. BE-expert endoscopists use the single biopsy method and turn-and-suction technique, whereas the double biopsy method and the advance-and-close technique are the more generally used biopsy techniques within non BE-expert endoscopists.

The BITE study is therefore designed to identify the preferred biopsy technique and method in BE patients in order to optimise biopsy quality and histopathological assessment.

Conditions

  • Barrett Esophagus

Interventions

OTHER

Biopsy technique

* Using the turn-and-suction technique, the forceps cups are opened and the forceps is withdrawn against the tip of the endoscope. The tip is then directed toward the target ('turn'), and suction is applied ('suction') as the forceps is applied against the targeted mucosa and then closed. * Endoscopists can obtain two biopsy specimens from a single passage of the conventional biopsy forceps instead of one. These techniques are called the 'double-biopsy method' and the 'single-biopsy method', respectively.

Sponsors & Collaborators

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • B. Weusten, prof. Dr. · St. Antonius Hospital

  • B. Weusten, prof. Dr. · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2024-09-30
Completion
2024-12-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05578677 on ClinicalTrials.gov