Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease

Официальное название

Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease - a Prospective Comparison of Pan-Enteric Capsule Endoscopy Versus Ileocolonoscopy Plus MR Enterography or Small-Bowel Capsule Endoscopy

Обзор

The goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose Crohn's disease instead of colonoscopy and a small bowel examination (either MRI or camera pill) in patients aged 18-40 years suspected of having Crohn's disease. The main question it aims to answer is: How many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations? Researchers will compare with patients examined with colonoscopy and a small bowel examination. Participants will: * Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination * Have their electronic medical records checked to see if a diagnosis has been made * Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found

Вмешательства

• Диагностический тест Panenteric capsule endoscopy
  Panenteric capsule endoscopy
• Диагностический тест Ileocolonoscopy
  Endoscopic examination of the colon and terminal ileum after bowel preparation.
• Диагностический тест MRI enterography
  MRI of the small bowel
• Диагностический тест Small bowel capsule endoscopy
  Capsule endoscopy of the small bowel

Первичные конечные точки

• Diagnostic completeness [Срок оценки: Immediately after initial diagnostic procedure]

Вторичные конечные точки (8)

• Feasibility of pan-enteric CE [Срок оценки: After completion of follow-up (12 months)]
• Additional examinations [Срок оценки: After completion of follow-up (12 months)]
• Safety [Срок оценки: After completion of follow-up (12 months)]
• Time to diagnosis [Срок оценки: After completion of follow-up (12 months)]
• Disease classification and medical treatments [Срок оценки: After completion of follow-up (12 months)]
• Patient satisfaction [Срок оценки: Immediately after initial diagnostic procedure]
• Costs [Срок оценки: After completion of follow-up (12 months)]
• Artificial intelligence [Срок оценки: Immediately after initial diagnostic procedure]

Критерии участия

Критерии включения

• Clinical suspicion of CD\*
• Age 18-40 years
• Signed informed consent

\*A clinical suspicion of CD is based on the following definition:

• Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) and either

• fecal calprotectin ≥ 200 mg/kg or
• fecal calprotectin ≥ 50 mg/kg plus one or more of the following findings:
• C-reactive protein (CRP) > 5 mg/L
• Thrombocytosis (> 400 x 109/L)
• Anemia (hemoglobin < 7.0 mmol/L for women and < 8.0 mmol/L for men or a decrease > 0.5 mmol/L compared to the usual level)
• Prolonged fever (> 37.5 ◦C for more than 2 weeks)
• Weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight)
• Perianal abscess / fistula
• Family history of inflammatory bowel disease.

Критерии исключения

• Previous intestinal resection
• Positive serologic markers for celiac disease
• Positive stool polymerase chain reaction for pathogenic bacteria
• Positive stool polymerase chain reaction for intestinal parasites
• Suspected or established acute bowel obstruction (ileus)
• Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion, except low-dose, prophylactic acetylsalicylic acid (≤ 150 mg per day)
• Intake of opioid or opioid-like medications ≤ 1 week before inclusion
• Pregnancy or lactation
• Inability to comply with protocol requirements, e.g. for reasons including alcohol or recreational drug abuse
• Known gastrointestinal disorder other than functional gastrointestinal disorders
• Renal failure defined by a plasma-creatinine above the normal reference range

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Дания · 4 центра

• Esbjerg Hospital - University Hospital of Southern Denmark — Esbjerg
• Odense University Hospital — Odense C
• Odense University Hospital - Svendborg Hospital — Svendborg
• Lillebaelt Hospital Vejle - University Hospital of Southern Denmark — Vejle

Швеция · 1 центр

• Skåne University Hospital — Malmö

Идентификаторы

NCT: NCT06882993 · 24/50881

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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