PANenteric Crohn's Capsule Versus Ileo-Colonoscopy and Scan Study

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 the patients' 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 the patients' symptoms are due to CD, which is important as the medication to heal the bowel is strong. But, these investigations 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. The investigators 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.

The investigators will compare the findings of all three tests. The investigators 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.

Conditions

• Crohn Disease

Interventions

DIAGNOSTIC_TEST

PillCamTM Crohn's capsule

Capsule endoscopy for small and large bowel to assess Crohn's disease activity.

DIAGNOSTIC_TEST

Magnetic resonance enterography

MRI scan of small bowel to assess small bowel Crohn's disease activity.

PROCEDURE

Ileo-colonoscopy

Endoscopic procedure to assess Crohn's disease activity in colon and terminal ileum.

Sponsors & Collaborators

• County Durham and Darlington NHS Foundation Trust

  collaborator OTHER_GOV

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• Newcastle University

  collaborator OTHER

• Durham University

  collaborator OTHER

• South Tyneside and Sunderland NHS Foundation Trust

  lead OTHER

Principal Investigators

• Simon Panter · South Tyneside and Sunderland NHS Foundation Trust

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-15

Primary Completion

2022-10-21

Completion

2022-10-21

Countries

• United Kingdom

Study Locations