Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05578677
Study type Interventional
Source St. Antonius Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date June 23, 2021
Completion date December 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03554356 - Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) N/A
Completed NCT03015389 - Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma
Completed NCT03434834 - OCT Pilot in Esophagus N/A
Terminated NCT04642690 - Nitrates and IL-8 in Barrett's Esophagus
Completed NCT03468634 - Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy N/A
Recruiting NCT02310230 - An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy N/A
Completed NCT00217087 - Endoscopic Therapy of Early Cancer in Barretts Esophagus Phase 2
Completed NCT02284802 - Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy N/A
Recruiting NCT05530343 - Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance N/A
Active, not recruiting NCT04151524 - Classification of Adenocarcinoma of the Esophagogastric Junction
Completed NCT00955019 - Novel Method of Surveillance in Barrett's Esophagus Phase 2
Terminated NCT00386594 - Pilot Study of Oral 852A for Elimination of High-Grade Dysplasia in Barrett's Esophagus N/A
Completed NCT00576498 - Novel Imaging Techniques in Barrett's Esophagus N/A
Completed NCT02688114 - Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus N/A
Recruiting NCT06071845 - Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples N/A
Completed NCT02560623 - A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus N/A
Recruiting NCT05056051 - Wide-Area Transepithelial Sampling in Endoscopic Eradication Therapy for Barrett's Esophagus N/A
Recruiting NCT04001478 - Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
Completed NCT03859557 - The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy
Completed NCT04587310 - Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study