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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 165
- 试验地点
- 12
- 主要终点
- Diagnostic completeness
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Traditional work-up
Colonoscopy and either MRI enterography or small bowel capsule endoscopy
干预措施: MRI enterography (Diagnostic Test)
Traditional work-up
Colonoscopy and either MRI enterography or small bowel capsule endoscopy
干预措施: Small bowel capsule endoscopy (Diagnostic Test)
Minimally invasive diagnostic algorithm
干预措施: Panenteric capsule endoscopy (Diagnostic Test)
Traditional work-up
Colonoscopy and either MRI enterography or small bowel capsule endoscopy
干预措施: Ileocolonoscopy (Diagnostic Test)
结局指标
主要结局
Diagnostic completeness
时间窗: Immediately after initial diagnostic procedure
Proportion of patients in each arm achieving a complete gastrointestinal assessment and an unambiguous diagnosis after completion of the initial diagnostic procedure(s) without need for supplementary examinations
次要结局
- Feasibility of pan-enteric CE(After completion of follow-up (12 months))
- Additional examinations(After completion of follow-up (12 months))
- Safety(After completion of follow-up (12 months))
- Time to diagnosis(After completion of follow-up (12 months))
- Disease classification and medical treatments(After completion of follow-up (12 months))
- Patient satisfaction(Immediately after initial diagnostic procedure)
- Costs(After completion of follow-up (12 months))
- Artificial intelligence(Immediately after initial diagnostic procedure)
研究者
Frederik Drejer Thrane
PhD Student
Esbjerg Hospital - University Hospital of Southern Denmark