Ensayos clínicos

Inclusion Criteria:

• Be a male or non-pregnant female.
• 18 to 75 years of age.
• A diagnosis of CD (established by conventional clinical, radiologic, endoscopic and histologic diagnostic criteria) as defined by the clinical guidelines of the European Crohn’s and Colitis Organization OR the American College of Gastroenterology.
• Be proficient in the English language (i.e., ability to read, write, speak, and understand English well enough to complete informed consent and take part in the interview process).
• Have documented symptomatic stricturing small bowel CD in reach of colonoscopy (i.e., starts within 15 cm of the ileocecal valve or the ileocecal anastomosis) within 4 weeks of study enrollment, with stricturing disease confirmed by cross-sectional imaging (CT, CTE, MR, MRE) read by study radiologists using diagnostic criteria as follows:
  • Localized luminal narrowing [luminal diameter reduction of at least 50% relative to a normal adjacent bowel loop]; AND
  • Bowel wall thickening [25% increase relative to adjacent nonaffected bowel]; AND either:
    • Pre-stricture dilation [luminal diameter greater than 3 cm]);
    • Inability to pass an adult or pediatric colonoscope through the narrowed area prior to dilation and unequivocal proximal small bowel dilation [but may be less than 3 cm].Endoscopic diagnosis of stricture based on inability to pass the colonoscope through the narrowed area should be within 6 months of cross-sectional imaging, and no endoscopic or surgical intervention has been performed since the time of the endoscopic examination.
• Have an anastomotic (post-surgical) and/or naïve stricture(s). Patients with only post-surgical stricture(s) must be at least one year past the date of previous surgery.
• Have known diagnosis of CD for at least 3 months.
• Have experienced clinical symptoms consistent with intestinal obstruction (e.g., bloating, abdominal distension, cramping, dietary restrictions, nausea/vomiting, abdominal pain, postprandial abdominal pain)2 within 4 weeks of study enrollment leading to most recent cross sectional imaging (i.e., CTe] or MRe]; OR have experienced obstructive symptoms co-occurring with a pre-scheduled cross sectional imaging test.
• Have provided written informed consent prior to study participation.

Exclusion Criteria:

• Internal penetrating disease as shown by fistula, abscess or inflammatory mass (phlegmon) detected by CTE or MRE.
• History of advanced abdominal malignancies, or receipt within the last year of chemotherapy, radiation, or other therapy which may interfere with symptoms of CD, in the opinion of the investigator.
• More than two distal ileal strictures at the time of baseline MRE or CTE (where 2 strictures within 3 cm are considered the same stricture; a long segment with multiple areas of narrowing or multiple strictures that have inflammation between them is counted as one stricture).
• Any colonic strictures.
• Cross sectional imaging findings not consistent with the stricture criteria for inclusion.
• Any ostomy.
• Active perianal disease.
• Diagnosis of ulcerative colitis.
• History of alcohol or drug abuse that in the opinion of the investigator or study director may interfere with the patient’s ability to comply with the study procedures.
• Any other comorbid condition or factor that, in the opinion of the investigator or study director, may confound participant’s experience of stricturing CD symptoms or otherwise interfere with ability to participate fully in a 90-min qualitative interview.