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The aim was to investigate whether endoscopic balloon dilatation combined with PRP injection can help prevent or prolong restenosis in patients with Crohn's disease with colonic stenosis, and to explore the concentration of PRP. The study was a single-center, randomized, non-controlled study. Experimental group of patients underwent endoscopic balloon dilation and submucosal injection of PRP at the wound edge, historical control was used, and the patients included in the study were randomly divided into high concentration group and low concentration group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP high concentration group | Experimental | Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with high concentration (platlet 2*10^6/μL) |
|
| PRP low concentration group | Experimental | Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with low concentration (platlet 1*10^6/μL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP Injection | Other | Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with different concerntrations |
|
| Measure | Description | Time Frame |
|---|---|---|
| restenosis rate | restenosis means the endoscopy with size of 10.5mm can not pass the stricture afer endotherapy | 3 months after endotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in intestinal ultrasound | the thickness of the stricture intestinal wall, and the width of the proximal intestinal cavity | 3 months after endotherapy |
| Proportion of surgery | The proportion of surgery due to stenosis or perforation |
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Inclusion Criteria:
Diagnosed as CD;
Exclusion Criteria:
The patient has contraindications for endoscopic therapy, such as coagulation disorder, severe cardiopulmonary dysfunction, active bleeding, and inability to cooperate.
Deep and large active ulcer was found in the stenosis;
< 18 years old;
Foreign patients;
Patients with a history of malignant tumors, including melanoma (except local skin cancer);
Pregnant or nursing patients;
Patients who could not be followed at all nodes of the primary outcome indicator; Other diseases that researchers believe could put patients at risk;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510655 | China |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 1 year after endotherapy |
| D007410 | Intestinal Diseases |