Study To Validate A Novel PRO Tool And Imaging Index Items In Stricturing Crohn’s Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-010927
Sponsor Protocol Number: STARWP3
About this study
The objectives of this study are to perform measured testing of the stricture PRO tool, including validation and assessment of responsiveness, and to assess responsiveness of the magnetic resonance image-based stricture radiology index (SRI) items.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Male or nonpregnant, nonlactating females, 18 to 75 years of age at the time of the baseline MRE.
- An established diagnosis of CD.
- Documented symptomatic stricturing small bowel CD in reach of colonoscopy (i.e., a portion of the stricture is located within 15 cm of the ileocecal valve or ileocecal anastomosis).
- Anastomotic or naïve small bowel CD stricture(s) at the time of the baseline MRE, where:
- Naïve small bowel stricture is defined by the combination of:
- localized luminal narrowing (luminal diameter reduction of at least 50% relative to normal adjacent bowel loop); AND
- bowel wall thickening (25% increase relative to adjacent nonaffected bowel); AND
- either:
- prestricture 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 (≥ 2.5 cm 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 MRE.
- An anastomotic stricture is defined the same as a naïve stricture, but at the site of prior intestinal resection with anastomosis.
- Clinical symptoms consistent with obstruction (e.g., bloating, abdominal distension, cramping, dietary restrictions, nausea/vomiting, abdominal pain, and/or postprandial abdominal pain) within 1 month of the baseline MRE.
- Ability of subject to participate fully in all aspects of this study.
- Written informed consent is obtained and documented.
Exclusion Criteria:
- Internal penetrating disease as shown by fistula, abscess, or inflammatory mass (phlegmon) at baseline. A blind-ending sinus tract is not excluded.
- Gastrointestinal malignancies.
- More than 2 distal ileal strictures at the time of baseline MRE (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 1 stricture).
- A terminal ileal stricture in a subject with end ileostomy, where the stricture is confined within the subcutaneous tissues and does not extend intra-abdominally.
- A diverting loop ileostomy proximal to the dominant stricture.
- Total proctocolectomy with an ileoanal or Kock pouch.
- Stricturoplasty in the distal ileum.
- Contraindication to MRE or inability to undergo MRE (e.g., claustrophobia).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Joel Fletcher, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available