Crohn’s Disease
Conditions
Interventions
Observation group:None
Sponsors
The Sixth Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years and above; 2. Patients who have previously received =5, and with ulcers present in any segment of the terminal ileum, proximal ileum, or jejunum; 4. Patients intending to start GUS treatment; 5. Disease duration of at least 3 months (defined as at least 12 weeks), confirmed by imaging, histology, and/or endoscopy, with current or previous involvement of the ileum or ileocolonic area in CD or fistulizing CD; 6. Patients with endoscopically confirmed ileocolonic lesions or isolated small bowel lesions, including moderate to severe inflammation in the proximal small intestine (duodenum, jejunum, or proximal-mid ileum).
Exclusion criteria
Exclusion criteria: 1. Patients who have used medications known to cause small bowel injury (such as nonsteroidal anti-inflammatory drugs) within 3 months prior to device-assisted small bowel endoscopy; 2. Patients with a history of intestinal resection, known intestinal obstruction, or current symptoms of obstruction; 3. Patients who have undergone gastrointestinal surgery within 3 months prior to enrollment, or have Crohn's disease-related complications requiring urgent/planned surgery or endoscopic intervention (such as abscess, stricture, or fistula); 4. Patients with sufficiently treated skin/perianal abscesses (>=3 weeks prior) or intra-abdominal abscesses (>=8 weeks prior) may be included if no further surgery is anticipated; 5. Difficulty swallowing; implanted cardiac devices; 6. Presence of severe comorbidities and active infections (including uncontrolled tuberculosis, human immunodeficiency virus [HIV] infection, hepatitis); 7. Patients with malignant tumors currently undergoing anticancer therapy; 8. Patients previously treated with IL-12/23 or IL-23 therapies (e.g., ustekinumab, briakinumab, guselkumab, mirikizumab, and risankizumab); 9. Other exclusion criteria: (1) Pregnancy or breastfeeding; (2) Unable to provide informed consent; (3) Currently participating in interventional clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endoscopic remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical remission rate;Transmural healing rate; | — |
Countries
China
Contacts
Public ContactGao Xiang
The Sixth Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed