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

NCT04274010 | Terminated DMC

• 1 other identifier: 275854
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

capsule endoscopy; ileocolonoscopy; magnetic resonance enterography

Outcome Measures

Primary Outcomes (1)

• Positive yields in Crohn's capsule vs ileo-colonoscopy and magnetic resonance enterography.

  To assess the rate of macroscopically detectable disease or "positive yields" by the PillCamTM Crohn's capsule compared to ileo-colonoscopy and magnetic resonance enterography in patients with an established diagnosis of Crohn's disease.

  4-6 weeks

Secondary Outcomes (5)

• Correlation between small bowel scoring systems.

  4-6 weeks

• Correlation between colonic scoring systems.

  4-6 weeks

• Positive diagnostic yield of Crohn's capsule with clinical severity of Crohn's disease.

  4-6 weeks

• Positive diagnostic yield of Crohn's capsule with patient quality of life.

  4-6 weeks

• Patient experience in each modality.

  4-6 weeks

Study Arms (1)

Crohn's capsule

OTHER

Single-arm non-randomised study, all participants will undergo MRE, ileo-colonoscopy and Crohn's capsule.

Diagnostic Test: PillCamTM Crohn's capsule; Diagnostic Test: Magnetic resonance enterography; Procedure: Ileo-colonoscopy

Interventions

PillCamTM Crohn's capsule DIAGNOSTIC_TEST

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

Crohn's capsule

Magnetic resonance enterography DIAGNOSTIC_TEST

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

Crohn's capsule

Ileo-colonoscopy PROCEDURE

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

Crohn's capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75
• Established diagnosis of Crohn's disease
• Patients who have been referred for IC and MRE for CD assessment as deemed appropriate by referring clinician as part of standard care

You may not qualify if:

• Indeterminate colitis or ulcerative colitis
• Stricturing disease - history consistent with obstruction e.g. nausea, vomiting, abdominal pain, bloating after meals or stricture seen on previous imaging
• Enteric fistulating disease based on clinical examination or previous imaging (perianal fistulae alone is allowed in the absence of anal strictures)
• Previous small bowel or colonic resection within 12 months
• Known or suspected bowel dysmotility
• Previous pelvic radiotherapy
• Insulin-treated diabetes mellitus
• Pregnancy
• Recent non-steroidal agent use within 4 weeks of study entry (excluding aspirin \<150mg per day)
• Contraindications to MRE, IC or capsule endoscopy
• Contraindications to taking bowel preparation

Sponsors & Collaborators

• South Tyneside and Sunderland NHS Foundation Trust: lead
• County Durham and Darlington NHS Foundation Trust: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• Newcastle University: collaborator
• Durham University: collaborator

Study Sites (1)

South Tyneside District Hospital

South Shields, Tyne and Wear, NE34 0PL, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Simon Panter

  South Tyneside and Sunderland NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: February 18, 2020
• Study Start: December 15, 2020
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)