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Endoscopic Biopsy Techniques in Barrett's Esophagus Patients (BITE)

Primary Purpose

Barrett Esophagus

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Biopsy technique
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Barrett Esophagus

Eligibility Criteria

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

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.

Sites / Locations

  • St. Antonius ZiekenhuisRecruiting
  • University Medical Center UtrechtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

A

B

C

D

Arm Description

Single-biopsy advance-and-close

Single-biopsy turn-and-suction

Double-biopsy advance-and-close

Double-biopsy turn-and-suction

Outcomes

Primary Outcome Measures

Size of biopsy specimen, as assessed by a blinded study investigator
Surface area of biopsy specimen in mm2

Secondary Outcome Measures

The percentage of biopsies in which the muscularis mucosae is present as assessed by a blinded upper GI-pathologist
Muscularis mucosa present, only strands of muscularis mucosa present, muscularis mucosa absent.
The percentage of biopsies with the presence of crush artefacts in the biopsy specimen, as assessed by a blinded upper GI-pathologist
Absent, <50% of the biopsy specimen, or >50% of the biopsy specimen
The number of lost biopsy specimens, as assessed by the endoscopy nurse
The number of times two biopsies have been taken, and only one biopsy specimen is present in the container that is sent to the pathology department
The total biopsy time, as assessed by the endoscopy nurse
Time between first insertion of the biopsy forceps until the last biopsy specimen has reached the jar, divided by the number of biopsies per patient
The percentage biopsies with the presence of dysplasia, as assessed by a blinded upper GI pathologist
The presence of dysplasia in biopsy specimens

Full Information

First Posted
January 7, 2022
Last Updated
October 10, 2022
Sponsor
St. Antonius Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05578677
Brief Title
Endoscopic Biopsy Techniques in Barrett's Esophagus Patients
Acronym
BITE
Official Title
Endoscopic Biopsy Techniques in Barrett's Esophagus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital

4. Oversight

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

5. Study Description

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, we 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.
Detailed Description
Our study will consist of three consecutive parts: a retrospective analysis, a two-by-two factorial randomised study, and a prospective before after study. The results of the preceding part of the BITE study will determine the continuation with subsequent part. If the second part of the BITE-study fails to identify a specific technique as the optimal biopsy technique (i.e. biopsy size is not significantly increased by using the single-biopsy turn-and-suction technique), we will not proceed with the third step of the BITE-study. Part I - retrospective analysis The retrospective analysis will be performed. This analysis of biopsy size aims to properly compare biopsy size of esophageal biopsies taken by BE-expert en non-expert endoscopists. Part II - Two-by-two factorial design randomised study The second part of the BITE study is a two-by-two factorial design randomised study. This is a prospective, individually randomised study and will be performed in two different hospitals in the Netherlands: St. Antonius Hospital Nieuwegein and University Medical Centre Utrecht (UMCU). Patients who are willing to participate will be randomised into four different groups: in group A, biopsies will be taken using the single-biopsy advance-and-close technique; in group B, biopsies are obtained by the single-biopsy turn-and-suction technique; in group C the double-biopsy advance-and-close technique will be used; and group D, biopsies will be taken by the double-biopsy turn-and-suction technique. All upper endoscopies will be performed by BE-expert endoscopists. Part III - retrospective before-after study The third and last part of the BITE study is a prospective before-after study. If the single-biopsy turn-and-suction technique proves to be the superior biopsy technique, this technique will be implemented among non BE-expert endoscopists. Non BE-expert endoscopists will be trained in the turn-and-suction technique, and data will be collected of biopsies before and after the training. If the second part of the BITE-study fails to identify the single-biopsy turn-and-suction technique as the optimal biopsy technique (i.e. biopsy size is not significantly increased by using the single-biopsy turn-and-suction technique), we will not proceed with the third step of the BITE-study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2x2 factorial design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Single-biopsy advance-and-close
Arm Title
B
Arm Type
Other
Arm Description
Single-biopsy turn-and-suction
Arm Title
C
Arm Type
Other
Arm Description
Double-biopsy advance-and-close
Arm Title
D
Arm Type
Other
Arm Description
Double-biopsy turn-and-suction
Intervention Type
Other
Intervention Name(s)
Biopsy technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Size of biopsy specimen, as assessed by a blinded study investigator
Description
Surface area of biopsy specimen in mm2
Time Frame
14 days
Secondary Outcome Measure Information:
Title
The percentage of biopsies in which the muscularis mucosae is present as assessed by a blinded upper GI-pathologist
Description
Muscularis mucosa present, only strands of muscularis mucosa present, muscularis mucosa absent.
Time Frame
14 days
Title
The percentage of biopsies with the presence of crush artefacts in the biopsy specimen, as assessed by a blinded upper GI-pathologist
Description
Absent, <50% of the biopsy specimen, or >50% of the biopsy specimen
Time Frame
14 days
Title
The number of lost biopsy specimens, as assessed by the endoscopy nurse
Description
The number of times two biopsies have been taken, and only one biopsy specimen is present in the container that is sent to the pathology department
Time Frame
Day 0, during the endoscopy
Title
The total biopsy time, as assessed by the endoscopy nurse
Description
Time between first insertion of the biopsy forceps until the last biopsy specimen has reached the jar, divided by the number of biopsies per patient
Time Frame
Day 0, during the endoscopy
Title
The percentage biopsies with the presence of dysplasia, as assessed by a blinded upper GI pathologist
Description
The presence of dysplasia in biopsy specimens
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilse Beaufort, Drs.
Phone
+31883206043
Email
i.beaufort@antoniusziekenhuis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B. Weusten, prof. Dr.
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
B. Weusten, prof. Dr.
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435 CM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I. Beaufort, Drs.
Phone
+31 88 320 6043
Email
i.beaufort@antoniusziekenhuis.nl
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I. Beaufort, Drs.
Phone
+31 88 320 6043
Email
i.beaufort@antoniusziekenhuis.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Endoscopic Biopsy Techniques in Barrett's Esophagus Patients

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