Barrett's Intervention for Dysplasia by Endoscopy (BRIDE)

This study is not yet open for participant recruitment.
Verified November 2012 by University Hospitals, Leicester
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University of Leicester
Information provided by (Responsible Party):
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT01733719
First received: November 20, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

LAY 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 Intervention
Barrett's Esophagus
Esophageal High-Grade Intraepithelial Neoplasia
Esophageal Cancer Stage I
Procedure: ER plus RFA
Procedure: ER plus APC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: BRIDE (Barrett's Randomised Intervention for Dysplasia by Endoscopy) - a Feasibility Study

Resource links provided by NLM:


Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • Recruitment rate and retention [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.


  • Persistence of HGD, cancer and benign Barrett's epithelium [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 measure at 12 months after baseline is:

    -Persistence of HGD or cancer

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



Secondary Outcome Measures:
  • Endotherapy complications [ Time Frame: 8 months (treatment period) ] [ Designated as safety issue: Yes ]
    Complications (bleeding requiring additional intervention, perforation, stricture)

  • Qualitative interviews with a subset of patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Clinician questionnaires on attitudes to surgery and endotherapy in early neoplastic Barrett's oesophagus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Health economic assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To will enable calculation of healthcare resource use for the duration of the study period

  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To measure quality of life using EQ-5D, EORTC QLQ-C30 and OES 18 in patients undergoing the 2 forms of endoscopic treatment


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • 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.

EXCLUSION CRITERIA:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733719

Contacts
Contact: John S de Caestecker, MD FRCP 00441162584796 john.decaestecker@uhl-tr.nhs.uk

Locations
United Kingdom
Gloucester Hospitals NHS Foundation Trust Not yet recruiting
Gloucester, United Kingdom
Principal Investigator: Hugh Barr, MD FRCS         
Royal Liverpool and Broadgreen NHS Trust Not yet recruiting
Liverpool, United Kingdom
Principal Investigator: Howard Smart, MD FRCP         
University College Hospital Not yet recruiting
London, United Kingdom
Principal Investigator: Laurence Lovat, PhD FRCP         
Queen's Medical Centre Not yet recruiting
Nottingham, United Kingdom
Principal Investigator: Krish Ragunath, MD FRCP         
Queen Alexandra Hospital Not yet recruiting
Portsmouth, United Kingdom
Principal Investigator: Pradeep Bhandari, MD FRCP         
Sponsors and Collaborators
University Hospitals, Leicester
National Institute for Health Research, United Kingdom
University of Leicester
Investigators
Principal Investigator: John S de Caestecker, MD FRCP University Hospitals, Leicester
  More Information

No publications provided

Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT01733719     History of Changes
Other Study ID Numbers: CLRN 119238
Study First Received: November 20, 2012
Last Updated: November 26, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on April 23, 2014