deltatrials
Completed NA INTERVENTIONAL 2-arm NCT02407392

Using Dilute Vinegar to Find Changes in Cells During Endoscopy for Patients With Barrett's Oesophagus (The ABBA Study) (ABBA)

Acetic Acid Guided Biopsies in Barrett's Surveillance for Neoplasia Detection Versus Non-targeted Biopsies (Seattle Protocol): A Feasibility Study for a Randomised Tandem Endoscopy Trial. The ABBA Study.

Sponsor: Brighton and Sussex University Hospitals NHS Trust

Updated 8 times since 2017 Last updated: Jul 1, 2024 Started: Jul 10, 2015 Primary completion: Jan 31, 2017 Completion: Feb 28, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Barrett Esophagus and is currently completed. Brighton and Sussex University Hospitals NHS Trust leads this study, which shows 8 recorded versions since 2015 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

This is a feasibility study to enable powering of a larger study. The investigators would assume a disease detection of 4.5% with acetic acid chromoendoscopy and 1.5% with protocol driven mapping biopsies. However, these assumptions are largely driven from a single centre cohort study and as such need clarification before they could be used for the purposes of powering a study. Based on the historical cohort studies and wide consultation within the British Society of Gastroenterology research committee and consultation with experts in the field, it is estimated that 200 patients would be reasonable for recruitment to enable the reproducibility and generalisability of this data to be established. The purpose of this study is not to produce statistically significant data in itself but to establish likely event rates and effect size to inform the power calculation for the definitive study.

This is a feasibility study to enable powering of a larger study. The investigators would assume a disease detection of 4.5% with acetic acid chromoendoscopy and 1.5% with protocol driven mapping biopsies. However, these assumptions are largely driven from a single centre cohort study and as such need clarification before they could be used for the purposes of powering a study. Based on the historical cohort studies and wide consultation within the British Society of Gastroenterology research committee and consultation with experts in the field, it is estimated that 200 patients would be reasonable for recruitment to enable the reproducibility and generalisability of this data to be established. The purpose of this study is not to produce statistically significant data in itself but to establish likely event rates and effect size to inform the power calculation for the definitive study.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotRecruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshotUnknown~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2024 — Present [monthly]

    Completed NA

  3. Aug 2024 — Sep 2024 [monthly]

    Completed NA

    Status: UnknownCompleted

  4. Jul 2024 — Aug 2024 [monthly]

    Unknown NA

    Status: Unknown StatusUnknown

  5. Jan 2021 — Jul 2024 [monthly]

    Unknown Status NA

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Unknown Status NA

  2. Apr 2018 — Jun 2018 [monthly]

    Unknown Status NA

    Status: RecruitingUnknown Status

  3. Jan 2017 — Apr 2018 [monthly]

    Recruiting NA

    First recorded

Jul 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Brighton and Sussex University Hospitals NHS Trust
  • Gloucestershire Hospitals NHS Foundation Trust
  • Portsmouth Hospitals NHS Trust
  • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
  • University Hospitals, Leicester
  • University of Portsmouth
  • Western Sussex Hospitals NHS Trust
Data source: Portsmouth Hospitals NHS Trust

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations