Barrett EsophagusBITENCT05578677
Endoscopic Biopsy Techniques in Barrett's Esophagus Patients
A study testing Biopsy technique in people with Barrett Esophagus, run by St. Antonius Hospital at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Biopsy technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesNetherlands
- Study dates
- 23 Jun 2021to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435 CM
University Medical Center Utrecht
Utrecht, 3584 CX
About this study
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.
Read the detailed description
This 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), the investigators 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), the investigators will not proceed with the third step of the BITE-study.
- Conditions
- Barrett Esophagus
- Being tested
- Biopsy technique
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy techniqueOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Single-biopsy advance-and-close Receives: Other: Biopsy technique |
| B | Other | Single-biopsy turn-and-suction Receives: Other: Biopsy technique |
| C | Other | Double-biopsy advance-and-close Receives: Other: Biopsy technique |
| D | Other | Double-biopsy turn-and-suction Receives: Other: Biopsy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of biopsy specimen, as assessed by a blinded study investigator
Surface area of biopsy specimen in mm2
Measured: 14 days
Secondary outcomes (5)
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.
Measured: 14 days
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
Measured: 14 days
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
Measured: Day 0, during the endoscopy
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
Measured: Day 0, during the endoscopy
The percentage biopsies with the presence of dysplasia, as assessed by a blinded upper GI pathologist
The presence of dysplasia in biopsy specimens
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start23 Jun 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilse Beaufort, St. Antonius Hospital
- Investigators
- B. Weusten, prof. Dr., Principal investigator, St. Antonius HospitalB. Weusten, prof. Dr., Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578677
- Sponsor's protocol ID
- W21.022
- Acronym
- BITE
- Status last verified
- Apr 2024
- First submitted
- 7 Jan 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Biopsy Techniques in Barrett's Esophagus Patients
- ClinicalTrials.gov ID
- NCT05578677
- Acronym / sponsor ID
- BITE / W21.022
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This 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), the investigators 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), the investigators will not proceed with the third step of the BITE-study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 factorial design
| Arm | Type | Receives |
|---|---|---|
| A | Other | Other: Biopsy techniqueSingle-biopsy advance-and-close |
| B | Other | Other: Biopsy techniqueSingle-biopsy turn-and-suction |
| C | Other | Other: Biopsy techniqueDouble-biopsy advance-and-close |
| D | Other | Other: Biopsy techniqueDouble-biopsy turn-and-suction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | A, B, C, D |
Primary outcome
Size of biopsy specimen, as assessed by a blinded study investigator
Time frame: 14 days
Surface area of biopsy specimen in mm2
5 secondary outcomes
The percentage of biopsies in which the muscularis mucosae is present as assessed by a blinded upper GI-pathologist
Time frame: 14 days
The percentage of biopsies with the presence of crush artefacts in the biopsy specimen, as assessed by a blinded upper GI-pathologist
Time frame: 14 days
The number of lost biopsy specimens, as assessed by the endoscopy nurse
Time frame: Day 0, during the endoscopy
The total biopsy time, as assessed by the endoscopy nurse
Time frame: Day 0, during the endoscopy
The percentage biopsies with the presence of dysplasia, as assessed by a blinded upper GI pathologist
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B. Weusten, prof. Dr. principal investigator
St. Antonius Hospital
B. Weusten, prof. Dr. principal investigator
UMC Utrecht
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy technique in people with Barrett Esophagus, run by St. Antonius Hospital at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of biopsy specimen, as assessed by a blinded study investigator (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.