Barrett&Apos;s Intervention for Dysplasia by Endoscopy (BRIDE)
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.
Esophageal High-Grade Intraepithelial Neoplasia
Esophageal Cancer Stage I
Procedure: ER plus RFA
Procedure: ER plus APC
|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&Apos;s Randomised Intervention for Dysplasia by Endoscopy) - a Feasibility Study|
- 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.
- 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
|Study Start Date:||February 2013|
|Study Completion Date:||November 2015|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733719
|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|
|Principal Investigator:||John S de Caestecker, MD FRCP||University Hospitals, Leicester|