Crohn Disease
Conditions
Brief summary
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.
Interventions
OTHERPRP Injection
Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with different concerntrations
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed as CD; * Stenosis of the colon was found during colonoscopy, and surgery was not considered for the time being; ③ Narrow length \<5cm; ④ 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; * 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; * Other diseases that researchers believe could put patients at risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| restenosis rate | 3 months after endotherapy | restenosis means the endoscopy with size of 10.5mm can not pass the stricture afer endotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in intestinal ultrasound | 3 months after endotherapy | the thickness of the stricture intestinal wall, and the width of the proximal intestinal cavity |
| Proportion of surgery | 1 year after endotherapy | The proportion of surgery due to stenosis or perforation |
Countries
China
Outcome results
None listed