Crohn’s disease–related ileocecal valve stricture
Conditions
Interventions
EBD followed by PRP injection (single arm):EBD followed by immediate local PRP injection
staged up to 3 sessions (M0, M1+/-7d, M2+/-7d
at least 1 session).
Sponsors
Yancheng First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for Crohn’s disease (CD); 2. Endoscopy and imaging studies (such as CT/MR enterography or transabdominal intestinal ultrasound) confirm a single or predominant stricture at the ileocecal valve, with a stricture length <= 5 cm; 3. The stricture is predominantly fibrotic, with no evidence of active penetrating disease or abscess formation; 4. Presence of chronic or intermittent symptoms related to obstruction, such as abdominal pain, bloating, and reduced passage of gas and stool; 5. Aged 18–75 years, regardless of gender; 6. The subject’s general condition is sufficient to tolerate endoscopic procedures and sedation/anesthesia; 7. The baseline treatment regimen for CD (e.g., 5-ASA, immunomodulators, biologics, etc.) has been relatively stable within the past 4 weeks, with no significant dose adjustments; 8. The subject voluntarily participates in this study, fully understands the study objectives, methods, and potential risks, and signs a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Stricture length > 5 cm, or multiple strictures/marked angulation, with anticipated high EBD risk or inability to complete the procedure; 2. Imaging or endoscopy suggests prominent deep ulcers, active fistula, adjacent abscess, or acute complete obstruction; 3. EBD or surgery at the same site within the past 3 months that would affect evaluation; 4. Significant coagulation abnormalities, or anticoagulant/antiplatelet therapy that cannot be discontinued; 5. Severe cardiopulmonary/hepatic/renal insufficiency, active infection, or pregnancy/lactation; 6. Other conditions deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility (enrollment and completion rate, PRP preparation success rate, technical success rate, follow-up completion rate);Safety outcomes (including AE/SAE incidence rate, perforation, clinically significant bleeding, infection/abscess, emergency surgery/hospitalization, death); | — |
Secondary
| Measure | Time frame |
|---|---|
| Obstruction symptom recording;Abdominal pain VAS;Harvey-Bradshaw Index;C-reactive protein;Erythrocyte sedimentation rate;Complete blood count;Albumin;Fecal calprotectin;Maximum dilated diameter;Endoscopic passability;Ulcer grading;Minimum luminal diameter;Bowel wall thickness;Blood flow score;Hyperechoic layer thickness;Reintervention/surgery and hospitalization within 3 months;Quality of life IBDQ; | — |
Countries
China
Contacts
Public ContactWu Xudong
Yancheng First People's Hospital
Outcome results
None listed