Title: Performance characteristics of PillCam(TM) Crohn’s compared with conventional ileocolonoscopy and Magnetic Resonance Enterography in the assessment of patients with Crohn’s disease (PAN-ICS study) (PANenteric Crohn’s capsule versus Ileo-Colonosocpy and Scan)
Funder: Department of Health and Social Care

Abstract: Background Crohn s disease (CD) is a chronic relapsing remitting condition resulting in inflammation in any part of the gastrointestinal tract from the mouth to the anus. It most commonly affects the small bowel and colon, resulting in diarrhoea, abdominal pain, rectal bleeding and weight loss. It is standard practice that the assessment of the small bowel and colon in patients with an established diagnosis of CD includes both magnetic resonance enterography (MRE) and ileocolonoscopy (IC). These assess deterioration in symptoms or response to treatment (in particular biological treatment to assess for mucosal healing), but currently, patients require both of these costly and invasive tests. Advancement in capsule endoscopy has led to the development of PillCam Crohn sTM (PCC) which allows panenteric assessment of the small bowel and colon in a single test, potentially removing the need for 2 separate tests. Recent feasibility studies utilising PCC or small bowel capsule or colon capsule have supported the concept of panenteric assessment via capsule endoscopy. There is an urgent need to understand the equivalence of PCC in the assessment of the small bowel and colon compared to usual care. Research question Is PCC comparable to current standard tests (IC+MRE) in the assessment of patients with known CD? Aims and objectives Aim: To assess if the diagnostic yield of PCC is comparable to IC+MRE in patients with an established diagnosis of CD. Primary objective: To assess the rate of macroscopically detectable disease or &ldquo;positive yields&rdquo;, by PCC compared to IC+MRE in patients with of CD. Secondary objectives: Association between the scoring system of each modality To compare the positive diagnostic yield of PCC with patient quality of life To assess the patient experience of each modality in a subset of patients Methods 125 patients planned to have disease assessment with IC+ MRE, as part of standard care, will be recruited over a 2-year period (September 2019-August 2021), to undergo all three investigations. All recruited patients will undergo patency capsule prior to PCC to ascertain gastrointestinal tract luminal patency. Where there is suggestion of patency capsule retention (confirmed by a CT scan), they will not proceed to the PCC. Bowel preparation is required prior to both colonoscopy and PCC; patient involvement demonstrated the importance of ensuring that patients only receive this once. Thus, the research team will endeavour for IC and PCC appointments to coincide. Data from all three investigations will be recorded and compared. Telephone interviews will be conducted to assess patient acceptability of PCC compared to IC+ MRE. Timelines, dissemination May 2019: completion of study documents and submission for ethical approval Oct 2019: commencement of patient recruitment Aug 2021: completion of study recruitment, commencement of data analysis Mar-Aug 2022: Write up of study results and submission of study results to peer reviewed journal and conferences Anticipated impact PCC has the potential to be more cost-effective, less invasive, less time-consuming and as such could have an extensive impact on patients with CD, their families, their employers, the NHS, and wider society.

Lay abstract: Background to the research Crohn s disease (CD) is a lifelong condition affecting the small and/or large bowel, causing diarrhoea, abdominal pain and weight loss. Patients with CD receive two tests to assess if their CD is active, namely ileocolonoscopy (camera examination of the large bowel, IC) and a scan of the small bowel (MRE). Together, these tests help determine if their symptoms are due to CD, which is important as the medication to heal the bowel is strong. But, they are uncomfortable, embarrassing and time consuming, and involve hospital visits to two separate departments. A new test involves swallowing a miniature camera, the size of a large vitamin pill (PillCam Crohn sTM (PCC)) that video-records the lining of the small and large bowel. Images are transmitted to a recorder worn over the tummy. We don t know if this one test (PCC) is the same (or better) than the two current tests (IC+MRE) in picking up active disease. Aim of the research To find out if the new PCC capsule delivers a single test that is comparable to current tests (IC+MRE) for patients with CD. Design and methods 125 patients with CD referred for IC+ MRE will be recruited from 3 NHS hospitals. Each patient will undergo all three tests (IC+ MRE and PCC). As there is a small risk of the capsule getting stuck (1-2 in 100 patients), all patients will have a &ldquo;dummy&rdquo; capsule to check that the &ldquo;real&rdquo; capsule can travel safely through the bowel. If successful (checked with a handheld scanner and CT scan if required), patients proceed to PCC. Patients will receive bowel preparation (a drink to clean the bowel) prior to IC and PCC. We will compare the findings of all three tests. We will interview patients to find out their experiences to inform the way the test is introduced into practice. Patient and public involvement Local patients with CD were consulted about the study design. They felt the research question is extremely important, and all preferred the prospect of having one non-invasive test over two invasive and uncomfortable tests. The group would be willing to participate in the trial despite having an extra test. The group expressed strong preference for a single bowel preparation; we will endeavour that patients have this once by ensuring their IC and PCC appointments coincide. A patient group will be established and consulted about study recruitment processes, data collection processes and data interpretation. Two nominated group members will be supported to attend and contribute to steering group meetings. Dissemination We will submit our results for publication to peer reviewed journals and conferences to make it available to doctors and patients worldwide

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: ORAL AND GASTROINTESTINAL