Assessment of the performance of the new generation Pillcam colon capsule (PCCE 2) in Crohn's disease: an exploratory study.

Assessment of the performance of the new generation Pillcam colon capsule (PCCE 2) in Crohn's disease: an exploratory study. - Pillcam study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35999

Enrollment

Registered

2012-02-01

Start date

2011-11-22

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease Inflammatory bowel disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Active Crohn's disease with CDAI > 150 * Elevated serum CRP (> 5 mg/l) and fecal calprotectin (> 200 ng/mg) * Prior documentation of colonic involvement by Crohn's disease in at least one segment of the colon and more severe than only aphthous lesions * Colonoscopy clinically indicated

Exclusion criteria

Exclusion criteria: * Any contraindication for colonoscopy or colon capsule examination including swallowing disorders, severe congestive heart failure, renal insufficiency * More than 1 resectional surgery for CD * Subtotal or total colectomy * Severely active fistulising disease * Jejunal Crohn's disease * HIgh suspicion of small bowel strictures * Short bowel syndrome or stoma

Design outcomes

Primary

Measure	Time frame
1. Diagnostic yield of PCCE 2 findings with attention to the type, size and location of lesions caused by Crohn's disease 2. Comparison of findings at PCCE 2 Pillcam recording and optical colonoscopy and validation of a Pillcam "inflammation score" using endoscopic scores as comparator	—

Secondary

Measure	Time frame
1. Safety and tolerability of the preparation procedure, the Pillcam examination and the optical colonoscopy 2. Determine inter-observer variability by serial readings of Pillcam recordings 3. Examine sensitivity and specificity of colonic Pillcam to detect mucosal healing in Crohn's patients before and after treatment with Infliximab or Adalimumab 4. Correlation of PCCE 2 findings and "inflammatory burden" measured by serum CRP and fecal Calprotectin	—

Measure

Time frame

1. Safety and tolerability of the preparation procedure, the Pillcam examination and the optical colonoscopy 2. Determine inter-observer variability by serial readings of Pillcam recordings 3. Examine sensitivity and specificity of colonic Pillcam to detect mucosal healing in Crohn's patients before and after treatment with Infliximab or Adalimumab 4. Correlation of PCCE 2 findings and "inflammatory burden" measured by serum CRP and fecal Calprotectin

—

Countries

Netherlands

Outcome results