When a patient is diagnosed with a rectal (bowel) polyp or cancer, radiology doctors read MRI scans to describe how deeply the cancer invades into the bowel wall (this is the 'stage' of the cancer). In this project, we will teach radiologists to find more early-stage rectal cancers. These are cancers that have only grown partially into the bowel wall. If we succeed, more patients could have these lesions removed by a local procedure that preserves the bowel and avoids the risks and complications of major surgery. We have developed a new method for radiology doctors to read MRI scans, which is more accurate than current practice. Currently only 3/10 of early rectal cancers are found by radiologists but by using our MRI reading system, 9/10 patients can be accurately identified as having early rectal cancer. We have proven that we can teach this method to other radiology doctors whose reports help to accurately inform patients of all possible treatment options, so they can be offered the option of a local procedure. In this initial work we will train radiology doctors in our MRI reading method in 20 hospitals. We will compare MRI reports before and after training to see if an accurate reading method improves treatments choices for patients. We will also determine whether more patients have local procedures after our training. The results of this initial work will help us to apply for national funding for a trial that we can quickly roll out to all NHS hospitals.
Many patients diagnosed with Early Rectal Cancer (ERC) are currently over-treated. Most patients with confirmed ERC will undergo an MRI, but some are not correctly identified in endoscopy and immediately removed. Of those who undergo MRI, 69% are over-staged and undergo major surgery or unnecessary radiotherapy when local excision surgery to preserve the patients rectum, and quality of life, would have been possible. \<10% of patients with ERC are staged accurately and offered local excision, with the majority who are staged as ERC on MRI still undergoing major surgery, likely due to uncertainty in the staging report. Prof Gina Brown developed a more accurate radiological staging system (PRESERVE) or ERC, whereby T2 tumours are identified and classified according to the degree of preservation of the individual layers of the rectal wall. It has been shown that PRESERVE enabled better identification of ERC suitable for local excision from the expected 30% to 89% accuracy. This improved accuracy was replicated in a further study by training a cohort of 12 radiologists. It is predicted that wider adoption of PRESERVE will result in increased organ-preserving surgery from the current rates of 10% to \>50%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
MRI scans will be recommended for all rectal polyps ≥20mm in size, or with other features suspicious of malignancy, prior to removal. This is designed to reduce the numbers of Early Rectal Cancers missed in endoscopy.
Radiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer.
Royal Berkshire Hospital
Reading, Berkshire, United Kingdom
NOT_YET_RECRUITINGBuckinghamshire Healthcare Nhs Trust
Amersham, Buckinghamshire, United Kingdom
RECRUITINGUniversity College London Hospitals Nhs Foundation Trust
London, Greater London, United Kingdom
NOT_YET_RECRUITINGKing'S College Hospital Nhs Foundation Trust
London, Greater London, United Kingdom
Impact of a training intervention on the accuracy of the tumour staging diagnosis through systematic reporting approach to MRI scans against current (pre intervention) practice.
Comparison of the proportion of patients with early rectal cancer who are diagnosed by pathology vs those staged as such by MRI, before and after the intervention.
Time frame: 1 year
Proportion of patients with technically adequacate scans before and after intervention
Proportion of patients scanned with high resolution MR in the correct planes
Time frame: 1 year
Proportion of primary tumour characterised by morphology and other features associated with malignancy before and after intervention
Proportion of reports where primary tumour has been characterised by morphology before and after intervention in i) endoscopy, ii) radiology reports before and after intervention
Time frame: 1 year
Proportion of MRI reports with T substage given before and after intervention
Proportion of reports where T substage of primary tumour has been recorded before and after intervention
Time frame: 1 year
Number of patients identified on imaging as suitable for rectal preservation by local excision
Proportion of imaging reports where suitable patients are identified on the report as suitable for rectal preservation by local excision being identified by the radiologist on the report before and after intervention
Time frame: 1 year
Number of patients identified by MDT as suitable for rectal preservation by local excision
Proportion of MDT decisions where patients suitable for rectal preservation by local excision are identified and comparison of treatments offered to patients by the MDT, before and after the intervention
Time frame: 1 year
Correlation of accuracy in the identification of safe plane of excision for rectal preservation by the radiologist
Proportion of patients with \>1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients with \>1mm submucosa preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients undergoing TME that have \<1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention
Time frame: 1 year
Numebr of patients with R0 by local excision or TME as appropriate
Proportion of patients with R0 that have \>1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients with R0 that have\>1mm submucosa preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients undergoing TME with R0 that have \<1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention
Time frame: 1 year
Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Comparison of QoL EORTC QLQ-CR29 scores before and after intervention. Questions relate to difficulty in performing every day tasks answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
Time frame: 1 year, 3 years, 5 years
Qualitative EORTC QLQ-CR30 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Comparison of QoL EORTC QLQ-CR30 scores before and after intervention. Questions relate to the presences of symptoms over the previous week answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
Time frame: 1 year, 3 years, 5 years
Qualitative LARS Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Comparison of LARS scores before and after intervention. Questions relate to bowel function answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
Time frame: 1 year, 3 years, 5 years
Qualitative Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Comparison of self evaluation of overall health and quality of life scores before and after intervention. Answers are rated from 1 very poor to 7 excellent
Time frame: 1 year, 3 years, 5 years
Comparison of total costs of procedures performed between patients undergoing local excision surgery to those undergoing major surgery
Comparison of total costs of hospital procedures performed based on individual pathways before and after intervention
Time frame: 1 year
Comparison of inpatient costs between patients undergoing local excision surgery to those undergoing major surgery
Comparison of cost of inpatient episodes based on individual pathways before and after intervention
Time frame: 1 year
Comparison of total cost of outpatient visits between patients undergoing local excision surgery to those undergoing major surgery
Comparison of total cost of outpatient episodes based on individual pathways before and after intervention
Time frame: 1 year
Comparison of total community costs between patients undergoing local excision surgery to those undergoing major surgery
Comparison of total cost of treatments delivered in the community based on individual pathways before and after intervention
Time frame: 1 year
Number of patients without disease and/or without stoma between patients undergoing local excision surgery, compared to those undergoing major surgery
DFS and stoma free survival in patients based on individual pathways before and after intervention
Time frame: 1 year, 3 years, 5 years
Assessment results for the effectiveness of mrSRT after a year from training
Determine longevity of training by assessment of radiologists trained with the PRESERVE mrSRT accuracy 1 year after training
Time frame: 1 year
Identification of histopathological biomarkers to improve selection of patients who can undergo rectal preserving strategies for Early Recal Cancer
Comparison of relative % histopathological biomarkers screening panels between patients identified on imaging as suitable for rectal preservation by local excision being identified by the radiologist on the report before and after intervention
Time frame: 2 months, 1 year, 3 years, 5 years
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West Middlesex Hospital
London, Greater London, United Kingdom
NOT_YET_RECRUITINGImperial College Healthcare Nhs Trus
London, Greater London, United Kingdom
NOT_YET_RECRUITINGThe Hillingdon Hospitals Nhs Foundation Trust
Uxbridge, Greater London, United Kingdom
NOT_YET_RECRUITINGHampshire Hospitals Nhs Foundation Trust
Basingstoke, Hampshire, United Kingdom
NOT_YET_RECRUITINGSouthampton General Hospital
Southampton, Hampshire, United Kingdom
NOT_YET_RECRUITINGKent & Canterbury Hospital
Canterbury, KENT, United Kingdom
NOT_YET_RECRUITING...and 13 more locations