Clinical trial · Interventional
Endoscopic Biopsy Techniques in Barrett's Esophagus Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy technique | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- A
- description
- Single-biopsy advance-and-close
- interventionNames
- Other: Biopsy technique
- type
- OTHER
- label
- B
- description
- Single-biopsy turn-and-suction
- interventionNames
- Other: Biopsy technique
- type
- OTHER
- label
- C
- description
- Double-biopsy advance-and-close
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * A diagnosis of Barrett's esophagus (maximum length ≥ 1cm) * Scheduled for surveillance endoscopy with random biopsies * In addition to the abovementioned inclusion criteria, a subject must meet the following criteria to participate in: Part I: endoscopy performed by BE expert or non-BE expert endoscopists Part II: endoscopy performed by BE expert endoscopist Part III: endoscopy performed by non-BE expert endoscopist Exclusion Criteria: * Very long BE segment (maximum length ≥ 10cm) * Any known clinical contraindication for obtaining biopsies (e.g. oesophageal varices, uncontrolled coagulopathy) * Biopsies of suspicious lesions in the Barrett's epithelium will be excluded from analysis in all parts of this study. In case of suspicious lesions, endoscopists (in part II and part III of the BITE study) are allowed to obtain biopsies according to the technique they prefer.
References
Publications (0)
Data not yet available