Endoscopic Biopsy Techniques in Barrett's Esophagus Patients

NCT05578677 | Active Not Recruiting

• 1 other identifier: W21.022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Size of biopsy specimen, as assessed by a blinded study investigator

  Surface area of biopsy specimen in mm2

  14 days

Secondary Outcomes (5)

• The percentage of biopsies in which the muscularis mucosae is present as assessed by a blinded upper GI-pathologist

  14 days

• The percentage of biopsies with the presence of crush artefacts in the biopsy specimen, as assessed by a blinded upper GI-pathologist

  14 days

• The number of lost biopsy specimens, as assessed by the endoscopy nurse

  Day 0, during the endoscopy

• The total biopsy time, as assessed by the endoscopy nurse

  Day 0, during the endoscopy

• The percentage biopsies with the presence of dysplasia, as assessed by a blinded upper GI pathologist

  14 days

Study Arms (4)

A

OTHER

Single-biopsy advance-and-close

Other: Biopsy technique

B

OTHER

Single-biopsy turn-and-suction

Other: Biopsy technique

C

OTHER

Double-biopsy advance-and-close

Other: Biopsy technique

D

OTHER

Double-biopsy turn-and-suction

Other: Biopsy technique

Interventions

Biopsy technique OTHER

* 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.

A; B; C; D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• A diagnosis of Barrett's esophagus (maximum length ≥ 1cm)
• Scheduled for surveillance endoscopy with random biopsies
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (2)

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• B. Weusten, prof. Dr.

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

• B. Weusten, prof. Dr.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs.

Model Details: 2x2 factorial design

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: October 13, 2022
• Study Start: June 23, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)