Barrett&Apos;s Intervention for Dysplasia by Endoscopy (BRIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01733719
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : March 11, 2016
National Institute for Health Research, United Kingdom
University of Leicester
Information provided by (Responsible Party):
University Hospitals, Leicester

Brief Summary:


A type of gullet cancer (oesophageal adenocarcinoma) has become the 5th commonest UK cause of cancer death. Unfortunately, by the time patients have symptoms, the cancer is often incurable. People with Barrett's oesophagus (change of gullet lining occurring in some with acid reflux) at risk of this cancer can have regular check-ups, involving examination through an endoscope (an instrument inserted by mouth, under mild sedation if required). A small proportion of people with Barrett's develop further changes (which might become cancer) in the gullet lining; if they do, it is important to remove the affected tissue before cancer develops, or when it is at an early stage.

There are several ways of removing this tissue but the investigators do not know which is best. The standard treatment is surgery, but there is a small risk of dying from the operation, and patients often suffer complications affecting them for a year or more afterwards. Two endoscopic treatments do not involve surgery. Both involve removing visible abnormalities by a technique called endoscopic resection, followed by cauterising the remaining Barrett's gullet lining by 1 of 2 techniques. One is recommended by the National Institute for Health and Clinical Excellence, but it is expensive and less widely available than the second. No-one has compared these treatments with each other, nor with surgery, in randomised trials (the most reliable way of deciding which is best). Patient groups say they would prefer to avoid surgery if the alternative works, and have encouraged us to do trials.

This feasibility study is a vital step towards two trials: (a) a trial to compare the two non-surgical techniques and (b) a trial comparing surgery with endoscopic treatment. It will help us find out whether it will be possible to enroll and retain enough patients by using several centres, and to identify/resolve any other potential barriers to recruitment and retention, including exploring viewpoints of patients and surgeons.

Condition or disease Intervention/treatment Phase
Barretts Esophagus Esophageal High-Grade Intraepithelial Neoplasia Esophageal Cancer Stage I Procedure: ER plus RFA Procedure: ER plus APC Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: BRIDE (Barrett&Apos;s Randomised Intervention for Dysplasia by Endoscopy) - a Feasibility Study
Study Start Date : February 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: ER plus RFA
Initial Endoscopic Resection of visible neoplasia/HGD in Barrett's esophagus followed by 4 x 2 monthly interventions (either ER of residual/metachronous visible lesions or RadioFrequency Ablation of 'flat' dysplastic or non-dysplastic Barrett's esophagus)
Procedure: ER plus RFA
Other Names:
  • Barrx HALO 360
  • Barrx HALO 90

Active Comparator: ER plus APC
Initial Endoscopic Resection of visible neoplasia/HGD in Barrett's esophagus followed by 4 x 2 monthly interventions (either ER of residual/metachronous visible lesions or Argon Plasma Coagulation of 'flat' dysplastic or non-dysplastic Barrett's esophagus)
Procedure: ER plus APC
2 litres/minute, 70 watts
Other Name: Erbe APC 'forward fire' endoscopic catheter

Primary Outcome Measures :
  1. Recruitment rate and retention [ Time Frame: 12 months ]

    BRIDE is a feasibility study randomising up to 100 patients with high grade dysplasia or early cancer in Barrett's oesophagus to two curative endoscopic non-surgical therapies (endoscopic resection and argon plasma photocoagulation versus endoscopic resection and radiofrequency ablation).

    Primary outcome measures at 12 months after baseline are:

    - Recruitment rate and retention

    The primary aim is to gain information that will enable realistic estimation of recruitment/retention rates in order to inform a fully powered trial (BRIDE 2) comparing the 2 endoscopic treatment techniques.

Secondary Outcome Measures :
  1. Endotherapy complications [ Time Frame: 8 months (treatment period) ]
    Complications (bleeding requiring additional intervention, perforation, stricture)

  2. Qualitative interviews with a subset of patients [ Time Frame: 12 months ]
    To determine patient attitudes to research in this disease in order to inform the definitive studies (BRIDE 2 and BREST - a trial comparing surgery with endoscopic treatment) planned to follow BRIDE.

  3. Clinician questionnaires on attitudes to surgery and endotherapy in early neoplastic Barrett's oesophagus. [ Time Frame: 12 months ]
    To investigate upper GI surgeons' and endoscopists' attitudes to research in this disease. This will inform a definitive study comparing surgery with endoscopic treatment planned to follow BRIDE.

  4. Health economic assessment [ Time Frame: 12 months ]
    To will enable calculation of healthcare resource use for the duration of the study period

  5. Quality of life [ Time Frame: 12 months ]
    To measure quality of life using EQ-5D, EORTC QLQ-C30 and OES 18 in patients undergoing the 2 forms of endoscopic treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histology: high grade dysplasia (HGD) or early cancer with a maximum depth of invasion on endoscopic resection (ER) of T1m3
  • Endoscopic ultrasound if any endoscopically visible abnormality: negative for T2 invasion or greater, and for suspicious lymph nodes.
  • CT scan (thorax & top 1/3 of abdomen): negative for evidence of locally advanced or metastatic disease (done at the discretion of the multidisciplinary team, for invasive cancer only - T1m disease); PET-CT will not usually be required but may be carried out if indicated at the discretion of the multidisciplinary team.
  • Suitability for trial agreed at local upper gastrointestinal cancer multidisciplinary team (MDT).
  • Able to give informed consent
  • Able (if applicable) to discontinue Clopidogrel for 7 days before & after endotherapy i.e. 14 days in total.
  • Able (if applicable) to discontinue Warfarin with or without a bridging plan using low molecular weight heparin. The Warfarin can be restarted 1-7 days after endotherapy according to the local endoscopist's usual clinical practice.


  • Histology: depth of invasion beyond muscularis mucosae histologically (> T1m), poorly differentiated T1m cancers or lymphatic invasion or vascular invasion.
  • Short tongues (<2 cm) of Barrett's epithelium that could be completely removed by Endoscopic Resection
  • No localised endoscopically identifiable abnormality by high definition endoscopy (with or without magnification or chromo-endoscopic techniques)
  • Prior oesophageal endoscopic therapy: e.g. Photodynamic Therapy, Endoscopic resection, prior ablation by other techniques such as argon ablation.
  • Existing symptomatic stricture or one caused by the study diagnostic ER unless this can be dilated and the patient is then judged to be suitable for endoscopic treatment by the expert endoscopist.
  • History of: radiation to mediastinum, oesophageal surgery (except fundoplication without complication), oesophageal varices or coagulopathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01733719

United Kingdom
Gloucester Hospitals NHS Foundation Trust
Gloucester, United Kingdom, gl13nn
Royal Liverpool and Broadgreen NHS Trust
Liverpool, United Kingdom
University College Hospital
London, United Kingdom
Queen's Medical Centre
Nottingham, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Sponsors and Collaborators
University Hospitals, Leicester
National Institute for Health Research, United Kingdom
University of Leicester
Principal Investigator: John S de Caestecker, MD FRCP University Hospitals, Leicester

Responsible Party: University Hospitals, Leicester Identifier: NCT01733719     History of Changes
Other Study ID Numbers: CLRN 119238
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Esophageal Neoplasms
Barrett Esophagus
Carcinoma in Situ
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Abnormalities
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type