CCE Newsletter - Issue 7 - October 2022
Dear All
CCE Study
If there is anything that you would like to see in the newsletter or if there is anything that you would like us to share with other sites please email the study team.
Update from the CI
We are grateful to all those patients, clinicians and researchers who are taking part in the CCE study. One of the great things about the study is it’s teaching us how we can use CCE in the real world at the same time as supporting prioritisation of diagnostic capacity within 49 hard pressed units up and down the country. Below are some initial results from the study:
- Over 3,703 capsules have been swallowed
- Approximately 69% of patients are being spared colonoscopy after CCE.
- For those who do go on to have a colonoscopy, approximately 64% of the time it is to treat significant polyp disease that has been identified.
- 36% of patients that are referred for an onward investigation only require a flexible sigmoidoscopy
- Careful patient selection and support remains important to reduce the risk of an incomplete or inadequate quality CCE. 62% of the time an incomplete CCE can be addressed through flexible sigmoidoscopy.
Recruitment
Feedback from sites has suggested that consenting in person on the day of the investigation by the clinical team or research team is leading to higher consent rates. Please ensure that your team is doing this and, if it is not possible, that you are consenting patients retrospectively and/or prospectively by post. If you are having any issues with consenting patients, please contact the study team.
As a reminder, sites are not permitted to offer CCE to patients who do not have a FIT result or have a FIT result >100ug/m. Sites are permitted to use CCE in patients with a FIT <10 ug/m as per the clinical guidance, however the focus of the study is patients with a FIT result between 10 and 100 ug/m.
If sites are not currently recruiting two week wait patients that are having a CTC or colonoscopy but would like to begin recruiting these patients, please contact the study team to discuss.
eCRF Completion
Based on the CRF uploads we are currently at 27% of our overall evaluation powering target with approx. 270 CRFs that have been partially completed. As you know, submission to the eCRF is an essential part of the pilot and all data on CCE procedures must be uploaded. We are currently lagging behind on data submissions to the eCRF, with around 50% of total activity having been submitted. Please review the first chart in the attached Evaluation Site Breakdown document to see how your site is performing and liaise with your R&D teams to address any issues.
The eCRF should be completed within 30 days from the initial investigation. We understand that patients who require further investigations may not have a final diagnosis within the 30 day period. For symptomatic patients and surveillance patients requiring an immediate follow-up investigation, the eCRF should not be submitted until all investigations have been completed and reported. For surveillance patients who have been referred for a colonoscopy or flexi-sigmoidoscopy deferred by a year, the form will ask for the projected date of investigation and allows you to submit the form without completing the details of the investigation.
The CRF for the Post-polypectomy surveillance patients is live! This will appear as a separate tab on the database. If you cannot see the tab for the surveillance CRF and you require access to it please contact the study team.
If you have any concerns about being able to complete the eCRF please contact the study team.
Patient Experience Study
Patients who have completed contact forms or patients have indicated on their consent form that they are happy for their contact details to be sent to the Sponsor are being sent a questionnaire about their experience by post or email. All of this is being done by the Trial Management Team at York, there is no involvement required by sites.
So far 728 patients have returned a questionnaire. If you receive any completed contact forms or patients have indicated on their consent form that they are happy for their contact details to be sent to the Sponsor please send these through to yhs-tr.ccestudy@nhs.net.
Focus group discussions and interviews that allow in-depth assessment of the themes that developed out of the questionnaire have begun with patients.
Information for Clinical Teams:
Sites Using Prucalopride
Anecdotal evidence from pilot sites suggests that in around 5% of patients, prucalopride has improved bowel transit so much that the capsule wakes up in the ascending colon and misses caecal views. Sites using prucalopride are advised to trial administering prucalopride 45 minutes before capsule ingestion in the next 20 patients.
Bowel Prep Shortages
As many of you are aware, there have been supply chain issues affecting the availability of Moviprep, Plenvu and, more recently, Fleet Phospha-soda.
We have received assurance from Norgine, the supplier of Moviprep and Plenvu, that stocks of both should be fully stabilised by the end of October.
Our Clinical Advisors have met to discuss these shortages and advise the following:
In the absence of Moviprep:
Plenvu should now be accessible. A low, split dose (500ml + 500ml) of Plenvu should be administered and patients should be advised to sip this over 30 minutes to reduce the risk of nausea. Trials in colonoscopy indicate equivalence and Plenvu has been used successfully in CCE in Israel and some NHS England pilot sites.
In the absence of Fleet Phospho-soda (NaP):
It’s possible that the current regimen (including prucalopride and gastrografin but excluding NaP) will be sufficient. Pilot sites unable to obtain NaP should trial the use of this restricted regimen in 5 consecutive patients to monitor outcomes.
Monitoring and reporting outcomes:
If trialling the above, it’s important to ensure that outcomes are carefully monitored and reported to the National Team. As well as reporting through the eCRF, please could we ask you to report successes and issues to scott.pygall@nhs.net so that we can share best practice and update national guidance, if necessary.
Meeting Slides & Recordings
Slides and recordings for CCE Delivery Group and drop-in sessions will be uploaded to the following Future’s workspace: CCE Governance Groups - Cancer Alliances Workspace - FutureNHS Collaboration Platform If you require access to the Future’s platform, please email Julie Townson j.townson@nhs.net
Dr Ana Terlevich, Consultant Gastroenterologist at North Bristol NHS Trust said:
“We are really excited at North Bristol NHS Trust to be taking part in this trial. This new colon capsule service will enable patients to safely have a cancer excluded without the need for an invasive procedure or sedation.
The technology involves swallowing a pill sized camera that takes a video of the bowel. The colon capsule requires minimal time spent in the hospital and our patients will be able to be at home during the majority of the investigation.
All of our patients should be confident that the NHS is safe and is here for them and so if you are experiencing symptoms, please get in touch.”
Evaluation Site Breakdown Sept-2022
