Barretts EsophagusBRIDENCT01733719
Barrett&Apos;s Intervention for Dysplasia by Endoscopy
A study testing ER plus RFA and ER plus APC in people with Barretts Esophagus and Esophageal High-Grade Intraepithelial Neoplasia, run by University Hospitals, Leicester at 5 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Barretts Esophagus, Esophageal High-Grade Intraepithelial Neoplasia, Esophageal Cancer Stage I
- What is being tested?
- ER plus RFA and ER plus APC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Feb 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Gloucester Hospitals NHS Foundation Trust
Gloucester, gl13nn
Royal Liverpool and Broadgreen NHS Trust
Liverpool
University College Hospital
London
Queen's Medical Centre
Nottingham
Queen Alexandra Hospital
Portsmouth
About this study
Official title: BRIDE (Barrett&Apos;s Randomised Intervention for Dysplasia by Endoscopy) - a Feasibility Study
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.
Read more
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.
Read the detailed description
The study will comprise 2 parts:
Firstly, randomising up to 100 suitable patients over a 1 year period, identified at the upper gastrointestinal cancer specialist multidisciplinary team meeting in 6 expert English centres. Patients will have either high grade dysplasia (HGD) or early cancer in Barrett's oesophagus (BE) and will be randomised to two curative endoscopic non-surgical therapies (endoscopic resection [ER] and argon plasma photocoagulation [APC] versus ER and radiofrequency ablation [RFA]). All techniques are used in current clinical practice, but have never been directly compared.
Secondly, 2 qualitative studies in which we will examine clinicians' and surgeon's attitudes towards a trial of oesophageal surgery compared to endoscopic treatment (ER and ablation) by questionnaire. Qualitative interviews with a purposive sample of patients will explore their views of randomisation, recruitment and participation to help identify and pre-empt problems in subsequent planned trials of endoscopic treatments compared to each other and to surgical removal of all or part of the gullet.
Participants will be randomised to the ER plus RFA or ER plus APC group at enrollment. The randomisation schedule will be managed by the University of Leicester Clinical Trials Unit, using a computer generated random assignment.
Randomisation will be stratified for length of Barrett's epithelium (< 5; 5-10; > 10 cm).
DETAILS OF SAMPLE SIZE
Currently available estimates of eradication rates have poor precision, being derived from small case series. Consequently the sample size has been chosen to allow estimation of the quantities of interest whilst not exposing too many patients to trial procedures.
10- -15 new cases per million population per year are treated. Each participating centre is based on an upper gastrointestinal cancer treatment centre serving 1.5- - 2 million people.
Since each centre would expect to see 15- - 20 new patients a year, we aim recruit up to 100 patients over 1 year from 6 UK centres.
ENDOSCOPIC INTERVENTIONS
ER, RFA and APC are all techniques used in current practice, with which all investigators are familiar. We will ensure that all investigators are using the same techniques and that histological assessment is scrutinised by an an external expert pathology panel (see quality control below).
Best practice is to perform ER of all visible lesions. We will therefore aim for complete resection of all visible lesions initially and ablate residual flat Barrett's mucosa at subsequent treatment sessions (at 2 monthly intervals up to 8 months after the initial treatment by ER).
The treatment phase of the trial terminates at 8 months. At T= 12 months, diagnostic high resolution endoscopy is performed with targeted biopsies of any abnormal areas as well as 4 quadrant biopsies at 2 cm intervals of the area containing or previously containing the BE. The biopsies are in order to identify 'buried' Barrett's glands under the new squamous epithelium. The clinical endpoint is at 1 year when recurrent or persistent HGD or cancer will be assessed. Any residual BE (not containing HGD or cancer) will be assessed and recorded.
QUALITATIVE STUDIES
A purposive sub-sample of patients (sampling strategy designed to include a wide range of views and experiences, including patients from each centre) will be interviewed by telephone after being invited to take part in the feasibility trial, using a topic guide (developed collaboratively with lay representatives, with an emphasis on encouraging patients to describe their own perspectives freely - a preliminary topic guide has been developed and is included with this application), exploring views on being invited to participate in research in which they are randomised to different treatment options. The interview would also invite views on conducting a trial of endotherapy versus surgery. Interviews will be audio-recorded with separate consent and transcribed verbatim by transcribers working to professional standards of confidentiality.
Analysis of Qualitative Data
Analysis of the interview transcripts will be based on the constant comparative approach and managed by NVivo software. The findings will thus include a set of issues that are important from a patient perspective, that can help/hinder recruitment and retention, to inform subsequent trials.
Surgeon/clinician Questionnaires
A purposive sample of surgeons and clinicians at expert centres will receive questionnaires to explore views to endotherapy and surgery for the treatment of Barrett's oesophagus with HGD or early cancer and on the proposed trials (including 'free text' options inviting views on randomization to a trial comparing surgery to endoscopic treatment). Questionnaires will be distributed to up to 100 oesophagogastric surgeons and clinicians (lead MDT gastroenterologists or expert endoscopists) from the participating centres and other centres in the UK as advised by our surgical lead. The questionnaires will be administered by e mail. A second e mail will follow after a month in the case of non-response, but those who chose not to respond thereafter will not be further contacted.
Quality of life assessments and healthcare cost assessment
Quality of Life will be assessed at baseline and at the 6 and 12 months visits, using the EORTC Quality of Life Questionnaire version 3.0 (EORTC QLQ-C30) and module QLQ-OES18 to assess specific relevant aspects of quality of life related to oesophageal disease. General quality of life will also be assessed using EQ-5D. Additional data on healthcare utilisation will be collected at baseline, 6 and 12 months using a questionnaire we have developed which patients will be asked to complete at these scheduled visits for endoscopy.
The perspective of the economic analysis will be that of the NHS and personal social service. Costs to be obtained will include the costs of endoscopic treatment and continued endoscopic surveillance in both groups, as well as any additional intervention after the initial 8- month therapeutic phase of the trial. The costs of any salvage treatment at any stage will be included. We will test the validity and feasibility of administering the economic evaluation questionnaire (patient healthcare utilisation questionnaire and EQ-5D), examining the response rate achieved and levels of missing data. EORTC QLQ- C30 will also be tested to directly estimate QALYs using EORTC- 8D. Both EQ-5D and EORTC will be used to obtain the appropriate information for cost per QALY analysis in future economic evaluation. The economic analysis will inform sample size calculation and other necessary information to calculate the cost savings for future economic evaluation.
- Conditions
- Barretts Esophagus, Esophageal High-Grade Intraepithelial Neoplasia, Esophageal Cancer Stage I
- Being tested
- ER plus RFA, ER plus APC
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ER plus RFAProcedure or surgery
Also called Barrx HALO 360, Barrx HALO 90
ER plus APCProcedure or surgery
Also called Erbe APC 'forward fire' endoscopic catheter
2 litres/minute, 70 watts
| Study group | Role | What they receive |
|---|---|---|
| ER plus RFA | Active comparator | 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) Receives: Procedure: ER plus RFA |
| ER plus APC | Active comparator | 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) Receives: Procedure: ER plus APC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate and retention
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.
Measured: 12 months
Secondary outcomes (5)
Endotherapy complications
Complications (bleeding requiring additional intervention, perforation, stricture)
Measured: 8 months (treatment period)
Qualitative interviews with a subset of patients
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.
Measured: 12 months
Clinician questionnaires on attitudes to surgery and endotherapy in early neoplastic Barrett's oesophagus.
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.
Measured: 12 months
Health economic assessment
To will enable calculation of healthcare resource use for the duration of the study period
Measured: 12 months
Quality of life
To measure quality of life using EQ-5D, EORTC QLQ-C30 and OES 18 in patients undergoing the 2 forms of endoscopic treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barretts EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Leicester
- Responsible party
- Sponsor
- Investigators
- John S de Caestecker, MD FRCP, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733719
- Sponsor's protocol ID
- CLRN 119238
- Acronym
- BRIDE
- Status last verified
- Mar 2016
- First submitted
- 20 Nov 2012
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Peerally MF, Bhandari P, Ragunath K, Barr H, Stokes C, Haidry R, Lovat L, Smart H, Harrison R, Smith K, Morris T, de Caestecker JS. Radiofrequency ablation compared with argon plasma coagulation after endoscopic resection of high-grade dysplasia or stage T1 adenocarcinoma in Barrett's esophagus: a randomized pilot study (BRIDE). Gastrointest Endosc. 2019 Apr;89(4):680-689. doi: 10.1016/j.gie.2018.07.031. Epub 2018 Aug 1.
PubMed 30076843
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRIDE (Barrett&Apos;s Randomised Intervention for Dysplasia by Endoscopy) - a Feasibility Study
- ClinicalTrials.gov ID
- NCT01733719
- Acronym / sponsor ID
- BRIDE / CLRN 119238
- Conditions
- Barretts Esophagus, Esophageal High-Grade Intraepithelial Neoplasia, Esophageal Cancer Stage I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Leicester
- Study start
- Feb 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will comprise 2 parts:
Firstly, randomising up to 100 suitable patients over a 1 year period, identified at the upper gastrointestinal cancer specialist multidisciplinary team meeting in 6 expert English centres. Patients will have either high grade dysplasia (HGD) or early cancer in Barrett's oesophagus (BE) and will be randomised to two curative endoscopic non-surgical therapies (endoscopic resection [ER] and argon plasma photocoagulation [APC] versus ER and radiofrequency ablation [RFA]). All techniques are used in current clinical practice, but have never been directly compared.
Secondly, 2 qualitative studies in which we will examine clinicians' and surgeon's attitudes towards a trial of oesophageal surgery compared to endoscopic treatment (ER and ablation) by questionnaire. Qualitative interviews with a purposive sample of patients will explore their views of randomisation, recruitment and participation to help identify and pre-empt problems in subsequent planned trials of endoscopic treatments compared to each other and to surgical removal of all or part of the gullet.
Participants will be randomised to the ER plus RFA or ER plus APC group at enrollment. The randomisation schedule will be managed by the University of Leicester Clinical Trials Unit, using a computer generated random assignment.
Randomisation will be stratified for length of Barrett's epithelium (< 5; 5-10; > 10 cm).
DETAILS OF SAMPLE SIZE
Currently available estimates of eradication rates have poor precision, being derived from small case series. Consequently the sample size has been chosen to allow estimation of the quantities of interest whilst not exposing too many patients to trial procedures.
10- -15 new cases per million population per year are treated. Each participating centre is based on an upper gastrointestinal cancer treatment centre serving 1.5- - 2 million people.
Since each centre would expect to see 15- - 20 new patients a year, we aim recruit up to 100 patients over 1 year from 6 UK centres.
ENDOSCOPIC INTERVENTIONS
ER, RFA and APC are all techniques used in current practice, with which all investigators are familiar. We will ensure that all investigators are using the same techniques and that histological assessment is scrutinised by an an external expert pathology panel (see quality control below).
Best practice is to perform ER of all visible lesions. We will therefore aim for complete resection of all visible lesions initially and ablate residual flat Barrett's mucosa at subsequent treatment sessions (at 2 monthly intervals up to 8 months after the initial treatment by ER).
The treatment phase of the trial terminates at 8 months. At T= 12 months, diagnostic high resolution endoscopy is performed with targeted biopsies of any abnormal areas as well as 4 quadrant biopsies at 2 cm intervals of the area containing or previously containing the BE. The biopsies are in order to identify 'buried' Barrett's glands under the new squamous epithelium. The clinical endpoint is at 1 year when recurrent or persistent HGD or cancer will be assessed. Any residual BE (not containing HGD or cancer) will be assessed and recorded.
QUALITATIVE STUDIES
A purposive sub-sample of patients (sampling strategy designed to include a wide range of views and experiences, including patients from each centre) will be interviewed by telephone after being invited to take part in the feasibility trial, using a topic guide (developed collaboratively with lay representatives, with an emphasis on encouraging patients to describe their own perspectives freely - a preliminary topic guide has been developed and is included with this application), exploring views on being invited to participate in research in which they are randomised to different treatment options. The interview would also invite views on conducting a trial of endotherapy versus surgery. Interviews will be audio-recorded with separate consent and transcribed verbatim by transcribers working to professional standards of confidentiality.
Analysis of Qualitative Data
Analysis of the interview transcripts will be based on the constant comparative approach and managed by NVivo software. The findings will thus include a set of issues that are important from a patient perspective, that can help/hinder recruitment and retention, to inform subsequent trials.
Surgeon/clinician Questionnaires
A purposive sample of surgeons and clinicians at expert centres will receive questionnaires to explore views to endotherapy and surgery for the treatment of Barrett's oesophagus with HGD or early cancer and on the proposed trials (including 'free text' options inviting views on randomization to a trial comparing surgery to endoscopic treatment). Questionnaires will be distributed to up to 100 oesophagogastric surgeons and clinicians (lead MDT gastroenterologists or expert endoscopists) from the participating centres and other centres in the UK as advised by our surgical lead. The questionnaires will be administered by e mail. A second e mail will follow after a month in the case of non-response, but those who chose not to respond thereafter will not be further contacted.
Quality of life assessments and healthcare cost assessment
Quality of Life will be assessed at baseline and at the 6 and 12 months visits, using the EORTC Quality of Life Questionnaire version 3.0 (EORTC QLQ-C30) and module QLQ-OES18 to assess specific relevant aspects of quality of life related to oesophageal disease. General quality of life will also be assessed using EQ-5D. Additional data on healthcare utilisation will be collected at baseline, 6 and 12 months using a questionnaire we have developed which patients will be asked to complete at these scheduled visits for endoscopy.
The perspective of the economic analysis will be that of the NHS and personal social service. Costs to be obtained will include the costs of endoscopic treatment and continued endoscopic surveillance in both groups, as well as any additional intervention after the initial 8- month therapeutic phase of the trial. The costs of any salvage treatment at any stage will be included. We will test the validity and feasibility of administering the economic evaluation questionnaire (patient healthcare utilisation questionnaire and EQ-5D), examining the response rate achieved and levels of missing data. EORTC QLQ- C30 will also be tested to directly estimate QALYs using EORTC- 8D. Both EQ-5D and EORTC will be used to obtain the appropriate information for cost per QALY analysis in future economic evaluation. The economic analysis will inform sample size calculation and other necessary information to calculate the cost savings for future economic evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ER plus RFA | Active comparator | Procedure: ER plus RFAInitial 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) |
| ER plus APC | Active comparator | Procedure: ER plus APCInitial 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) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ER plus RFAAlso: Barrx HALO 360, Barrx HALO 90 | Procedure or surgery | ER plus RFA |
| ER plus APCAlso: Erbe APC 'forward fire' endoscopic catheter2 litres/minute, 70 watts | Procedure or surgery | ER plus APC |
Primary outcome
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.
5 secondary outcomes
Endotherapy complications
Time frame: 8 months (treatment period)
Qualitative interviews with a subset of patients
Time frame: 12 months
Clinician questionnaires on attitudes to surgery and endotherapy in early neoplastic Barrett's oesophagus.
Time frame: 12 months
Health economic assessment
Time frame: 12 months
Quality of life
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Derived from this study: PubMed 30076843Peerally MF, Bhandari P, Ragunath K, Barr H, Stokes C, Haidry R, Lovat L, Smart H, Harrison R, Smith K, Morris T, de Caestecker JS. Radiofrequency ablation compared with argon plasma coagulation after endoscopic resection of high-grade dysplasia or stage T1 adenocarcinoma in Barrett's esophagus: a randomized pilot study (BRIDE). Gastrointest Endosc. 2019 Apr;89(4):680-689. doi: 10.1016/j.gie.2018.07.031. Epub 2018 Aug 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S de Caestecker, MD FRCP principal investigator
University Hospitals, Leicester
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ER plus RFA and ER plus APC in people with Barretts Esophagus and Esophageal High-Grade Intraepithelial Neoplasia, run by University Hospitals, Leicester at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate and retention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01733719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.