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This study is designed as a controlled trial to evaluate the efficacy of balloon-assisted enteroscopy-guided radial incision therapy for the treatment of stricturing small bowel Crohn's disease. The study aims to compare therapeutic outcomes, procedure-related complications, and recurrence rates in patients with stricturing small bowel Crohn's disease undergoing balloon-assisted enteroscopy-guided radial incision therapy. The results are expected to provide a novel and reliable treatment option for patients with stricturing Crohn's disease and to lay a foundation for improving disease-related symptoms and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention | Sham Comparator | Patients in this arm will not receive endoscopic interventional treatment for small bowel strictures and will be managed with standard medical therapy and clinical observation. |
|
| Balloon-assisted enteroscopy-guided balloon dilation | Experimental | Patients in this arm will undergo balloon dilation of small bowel strictures under balloon-assisted enteroscopy to relieve luminal narrowing. |
|
| Balloon-assisted enteroscopy-guided stricture incision | Experimental | Patients in this arm will receive balloon-assisted enteroscopy-guided radial incision of small bowel strictures under direct endoscopic visualization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stricture incision | Procedure | Balloon-assisted enteroscopy-guided stricture incision versus balloon dilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up | Percentage of patients who do not require any new therapeutic intervention, including endoscopic balloon dilation (EBD), endoscopic stricture incision (EST), or surgery, within 1 year after the initial procedure. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients not requiring additional therapeutic interventions at 3-year follow-up | Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 3 years after the initial procedure. | 3 years |
| Proportion of patients not requiring additional therapeutic interventions at 5-year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shenglong Xia, Phd | Contact | +86-19857128950 | xsl89@zju.edu.cn | |
| Surong Hu, PhD | Contact | +86-15868532956 | 526315332@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Chen, PhD | Second Affiliated Hospital of Zhejiang University School of Medicine | Principal Investigator |
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| balloon dilation | Procedure | Balloon-assisted enteroscopy-guided balloon dilation |
|
| No Interventions | Procedure | No Intervention |
|
Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 5 years after the initial procedure. |
| 5 years |
| Safety assessment of the two treatment methods | Evaluation of procedure-related complications, including postoperative bleeding, perforation, and any adverse events (AEs) or serious adverse events (SAEs) occurring within 2 months after the procedure. | Within 2 months post-procedure |
| Immediate technical success of the procedure | Assessment of successful passage of the endoscope through the stricture immediately after balloon dilation or stricture incision. | At the time of procedure |
| Symptom-free duration within 1 year post-procedure | Duration of symptom-free period within 1 year after the procedure, defined as a score ≤1 on the obstruction symptom assessment scale. | 1 year |
| Cost analysis of the two treatment methods | Comparative analysis of medical costs associated with balloon dilation versus stricture incision, including procedure, hospitalization, and follow-up expenses. | Up to 1 year post-procedure |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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