PAN-ICS Study v1.0

  • Research type

    Research Study

  • Full title

    PANenteric Crohn's capsule versus Ileo-Colonoscopy and Scan Study

  • IRAS ID

    275854

  • Contact name

    Simon Panter

  • Contact email

    simon.panter@stft.nhs.uk

  • Sponsor organisation

    South Tyneside and Sunderland NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT04274010

  • Duration of Study in the UK

    1 years, 9 months, 1 days

  • Research summary

    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 ileo-colonoscopy (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, 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’s (PCC)) that video-records the lining of the small and large bowel. Images are sent to a recorder worn over the tummy. We aim to find out if the PCC capsule delivers a single test that is comparable to current tests (IC+MRE) for patients with CD.
    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 (up to 3 in 100 patients), all patients will have a “dummy” capsule to check that the “real” 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. When consulted, local patients with CD felt the research question is extremely important and all preferred having one non-invasive test over two invasive and uncomfortable tests.

  • REC name

    West of Scotland REC 5

  • REC reference

    20/WS/0007

  • Date of REC Opinion

    6 Feb 2020

  • REC opinion

    Further Information Favourable Opinion