Endoscopic Balloon Dilatation Combined With PRP Injection in Colonic Stenosis in Crohn's Disease

Study Overview
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Brief Summary
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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 (PRP prepared by the blood transfusion department of our hospital) 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.

Official Title
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Efficacy and Safety of Endoscopic Balloon Dilatation Combined With Autologous Platelet-rich Plasma (PRP) Injection in Colonic Stenosis in Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: PRP Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as CD; Stenosis of the colon was found during colonoscopy, and surgery was not considered for the time being; ③ Imaging stenosis was found, that is, CTE suggested stenosis with proximal intestinal dilatation >3cm; Narrow length <5cm; ⑤ The patients agreed to undergo endoscopic balloon dilatation and voluntarily signed the informed consent to participate in this study, and were capable of complying with the agreement. 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; ④ Foreign patients; ⑤ Patients with a history of malignant tumors, including melanoma (except local skin cancer); ⑥ Pregnant or nursing patients; ⑦ Patients who could not be followed at all nodes of the primary outcome indicator; Other diseases that researchers believe could put patients at risk; ⑧ Other diseases that researchers believe could put patients at risk.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP high concentration group<br>Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with high concentration (platlet 2*10^6/μL) | Other: PRP Injection<br>* Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with different concerntrations<br>|
| Experimental: PRP low concentration group<br>Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with low concentration (platlet 1*10^6/μL) | Other: PRP Injection<br>* Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with different concerntrations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 1 year after endotherapy |