Barrett Esophagus Clinical Trial
— BITEOfficial title:
Endoscopic Biopsy Techniques in Barrett's Esophagus Patients
Verified date | April 2024 |
Source | St. Antonius Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | December 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | St. Antonius Ziekenhuis | Nieuwegein | Utrecht |
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
St. Antonius Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Size of biopsy specimen, as assessed by a blinded study investigator | Surface area of biopsy specimen in mm2 | 14 days | |
Secondary | 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. | 14 days | |
Secondary | 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 | 14 days | |
Secondary | 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 | Day 0, during the endoscopy | |
Secondary | 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 | Day 0, during the endoscopy | |
Secondary | The percentage biopsies with the presence of dysplasia, as assessed by a blinded upper GI pathologist | The presence of dysplasia in biopsy specimens | 14 days |
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