Clinical trials

This international, multi-centre randomised controlled trial will compare dye-based chromoendoscopy with virtual chromoendoscopy, using NBI/BLI, for adenoma detection during routine surveillance pouchoscopy in adults with familial adenomatous polyposis (FAP) and an ileal pouch-anal anastomosis (IPAA). The estimated study duration is 2 years. Participants will undergo their usual scheduled pouchoscopy, performed by endoscopists experienced in FAP. Before the procedure, they will be randomised 1:1 to dye-based or virtual chromoendoscopy. Adenomas requiring endoscopic treatment will be removed during the same procedure according to standard practice. To our knowledge, no previous study has directly compared these techniques in this setting. Current guidelines recommend surveillance in patients with FAP and a pouch and permit dye-spray chromoendoscopy, but do not specify whether dye-based or virtual chromoendoscopy should be preferred. Practice varies between centres: virtual chromoendoscopy is commonly used at St Mark's Hospital, while some European centres primarily use dye-based chromoendoscopy. This study therefore aims to standardise practice and generate evidence to inform future surveillance strategies. Eligible patients will be adults aged ≥18 years with FAP, defined by a proven APC germline mutation or a clinical diagnosis of \>100 colorectal adenomas with a positive family history, and who have undergone IPAA after primary proctocolectomy or secondary proctectomy following IRA/ISA. Patients will be identified through routine endoscopy booking systems. Those who have consented to email communication from the Polyposis Registry team will receive a Participant Information Sheet in advance. They will be approached again on the day of their procedure, given the opportunity to ask questions, and consented before randomisation. Patients who do not consent will undergo their planned pouchoscopy as normal, without study randomisation. Patients lacking capacity to consent will not be approached. Randomisation will be performed using an independent computer-generated programme within Castor EDC, with allocation in a 1:1 ratio. Block randomisation will ensure balanced distribution between arms within each centre, and stratification by centre will account for differences in patient characteristics and local practice. Blinding is not feasible because dye-based and virtual chromoendoscopy have visually distinct appearances. During pouchoscopy, the pre-pouch ileum, pouch body and rectal cuff will be carefully inspected. In the dye-based arm, indigo carmine will be applied using a spray catheter before withdrawal and mucosal inspection. In the virtual chromoendoscopy arm, inspection will be performed using NBI/BLI according to local platform availability. The endoscope will be advanced to the pre-pouch ileum, followed by systematic withdrawal and spiral mucosal inspection. Lesions will be documented by size and location, including pouch body and rectal remnant/rectal cuff, using a polyp burden scoring table. Retroflexion will be performed to assess the rectal cuff. Polyp size will be estimated in millimetres, supported where appropriate by biopsy forceps of known size. Adenomas will be resected using standard polypectomy techniques where indicated, including polyps \>5 mm in the pouch body, \>2 mm in the rectal cuff, or lesions suspicious for high-grade dysplasia or early cancer. Because assessment of small polyps can vary between endoscopists, particularly for lesions \<5 mm, endoscopic images will be used to assess inter-rater and intra-rater reliability for polyp burden and size. If reliability is acceptable, smaller polyps will be included and reported. Quality parameters will be collected for each procedure, including adjusted Boston Bowel Preparation Scale assessment for the pouch and total procedural time. Procedural time will include scope introduction, irrigation, dye application where applicable, withdrawal and inspection, retroflexion, and removal and retrieval of polyps. Post-procedure follow-up will follow routine care. Patients will be asked to monitor for adverse events after pouchoscopy and contact the hospital if needed. Future surveillance will be scheduled according to each centre's usual policy. Study data will be held in routine hospital systems accessible to the patient's usual clinical team and in a study file. Participants will be assigned a study number. No identifiable patient information will leave the Trust or be accessible to anyone outside the usual care team. Anonymised data will be entered into Castor EDC. Pseudonymised data will be transferred to the central study team at Amsterdam University Medical Center under an existing data transfer agreement for pooled analysis. The study does not expose participants to risks beyond routine surveillance pouchoscopy. There is no direct individual benefit but findings may benefit future patients with FAP and families by improving evidence.

* Chest pain is one of the most common symptoms of heart disease. This could be due to narrowing in heart's blood vessels, which needs to be investigated. * Currently, people with a low risk of narrowing of heart vessels usually have a CT scan of the heart first. This scan is good at identifying those who do not have significant narrowing. However, the scan has some drawbacks, such as exposure to a small amount of radiation. * We are exploring if ultrasound of the neck vessels might give us similar kind of information as the CT scan. * You will be asked to attend the hospital for one visit to have an ultrasound scan of your neck. * The findings of your neck vessels will be compared with the CT scan of your heart vessels to see if there is a similarity.

Atherosclerotic plaques, the build-up of fatty materials within our arteries, can develop over a long period of time without causing any symptoms. These plaques may continue to grow and rupture causing narrowing and blockages of the blood vessels. This can lead to serious cardiovascular disease such as a heart attack or stroke causing over 160,000 deaths each year. Lots of research has been done on why particular groups of people may develop atherosclerosis and controlling risk factors such as diabetes and high blood pressure go a long way to reduce people's risks. However, despite the treatments we have available and controlling these risk factors, some people unfortunately still go on to develop a potentially serious disease. Further research has shown us that certain plaques in the blood vessels may be more vulnerable to rupturing compared to others. So far we know that plaques with thin caps, soft centres or those that are able to grow their own tiny blood vessels are more likely to rupture. We have now started to develop new imaging methods to try and help us detect these vulnerabilities. The hope is by being able to detect more vulnerable plaques we may be able to treat these earlier and therefore more effectively. There are different scans available to try and visualise the tiny vessels within these plaques in the neck arteries. These include, MRI (a Magnetic Resonance Imaging scan, taking pictures using a small tunnel), CT (Computed Tomography, uses a ring-shaped machine to take pictures), and ultrasound. Ultrasound has the benefit of being free of ionising radiation and iodinated contrast, therefore posing less risk to patients. However, current ultrasound uses 2D ultrasound. Although this has shown promising results, our blood vessels and any plaques are 3D structures so we don't get to see the whole plaque using 2D imaging and therefore may miss important information. The available 3D probes in use at the moment are not able to visualise the tiny vessels accurately enough. This study uses a different 3D ultrasound probe and ultrasound machine that is able to produce many more images than our usual probes. By taking images with this probe and using offline computer programmes to track the contrast through structures we hope that this system will be able to give us a visualisation of the whole plaque enabling us to detect any new blood vessels more accurately.

Texture and Colour Enhancement Imaging (TXI) improves texture, brightness, and colour in white-light endoscopy to highlight subtle tissue differences. Now available through the EVIS X1 system, early evidence suggests potential value in IBD. Studies show that TXI may help predict ulcerative colitis relapse and performs comparably to dye chromoendoscopy in detecting lesions, though no randomised data exist for dysplasia detection in IBD surveillance. We therefore propose a randomised paired study comparing TXI with high-definition white-light endoscopy for dysplasia detection in IBD surveillance.

Diseases of the heart and circulation are known as cardiovascular diseases, and they cause over 160,000 deaths each year. Coronary heart disease (CHD) is the most common cardiovascular disease. This is due to a build-up of fatty material, known as atherosclerosis, in the blood vessels supplying blood to the heart muscle. This can cause chest pain or if blocked, can cause a heart attack. Two of the main non-invasive tests to look for coronary heart disease are Computed Tomography Coronary Angiography (CTCA) and Stress Echocardiography (Ultrasound scan). CTCA shows the arteries and allows small amounts of disease to be seen that may not yet be causing any symptoms. However, if there's lots of disease and calcification, it becomes difficult to tell how severe it is, which means several tests may be needed. Stress Echocardiography shows if enough blood is reaching the heart muscle, so can show if there is severe disease that needs treatment. However, it can't see the arteries so doesn't showt small disease that may benefit from tablet treatment. There is not yet an effective non-invasive combined test that can give all this information in one go. Studies have shown that if there's atherosclerosis in another artery, a person is very likely to have coronary atherosclerosis as well. Carotid atherosclerosis, in the neck arteries, can be seen with ultrasound similar to stress echocardiography. So, by combining these two tests the investigators want to see if it is possible to see severe as well as small areas of disease in one test, to provide better treatment. The study will enrol 2,000 participants, who need investigation for CHD, equally randomised to CTCA or stress echocardiography with carotid ultrasound. We will follow these participants for 5 years and observe for any adverse outcomes and ask them to complete a questionnaire.

In individuals with inflammatory bowel disease (IBD), bowel cancer can develop from abnormal cell changes (dysplasia). Regular colonoscopies are recommended to identify these early changes, which can be difficult to detect because they are often small and subtle. Dye-based imaging has been used to improve detection, but it requires additional preparation and time. Texture and Colour Enhancement Imaging (TXI) is a newer method available in clinical practice that adjusts brightness, colour, and texture on high-definition cameras. This study will compare TXI with dye-based imaging to assess which approach detects precancerous changes more effectively in patients with IBD.

The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence. This is particularly important as afflicted individuals may not readily volunteer information about their symptoms and struggles and need to be safeguarded by the presence of robust care pathways that ensure adequate follow up and care provision. As obstetric anal sphincter injuries have been associated with increased litigation rates over the years, positive interventions towards patient care will help ameliorate the financial burden that litigation carries on the National Health Service. It is noteworthy of mention that perineal injury, in itself, may not be suggestive of negligent care and is a recognized complication of vaginal delivery. However, a failure to adequately manage the injury may carry medicolegal implications.

The study will compare standard ultrasound images to high frame rate ultrasound images in patients with heart disease or with a low risk of heart disease to see if a higher frame rate of ultrasound adds to the information obtained from standard ultrasound.

Why? PSYLIVED is a qualitative study that aims to understand the psychological experience of individuals living with inherited colorectal cancer. It addresses the question of how individuals cope emotionally and adapt to the unique challenges they face. This research sheds light on the emotional journey of those with inherited colorectal cancer, potentially leading to improved support services, interventions, and care practices tailored to their needs. The study seeks to enhance the well-being of patients undergoing genetic testing and contribute to better services and support practices. What? PSYLIVED is a qualitative study that will employ reflexive Thematic Analysis methodology to explore the emotional responses and experiences of participants over time. Who? The investigators are interested in interviewing between 30 to 66 individuals who have first-hand experience of being at risk or having an inherited colorectal cancer syndrome. Where? While the study is conducted by the St Mark's Centre for Familial Intestinal Cancer, this study is open to individuals in the UK. Interviews will primarily be conducted via telephone or Microsoft Teams to facilitate accessibility. However, participants residing near London who prefer face-to-face interviews will be offered this option. How? Each participant will take part in a one-hour audio-recorded interview where they will be asked to talk about their experiences. The interview will be recorded, so it can be transcribed word by word. During the transcription, the interview will be anonymised to ensure confidentiality. The responses will then be compared and analysed to create a result summary, along with interviews from other individuals with similar experiences. The study is set to commence in June 2024, with recruitment open for approximately two years.