Endoscopic Balloon Dilatation Combined With PRP Injection in Colonic Stenosis in Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRP Injection.
- Who it may be relevant to
- Registry conditions: Crohn Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Endoscopic Balloon Dilatation Combined With Autologous Platelet-rich Plasma (PRP) Injection in Colonic Stenosis in Crohn's Disease
Overview
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
- Other PRP Injection
Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with different concerntrations
Primary outcome measures
- restenosis rate [Time frame: 3 months after endotherapy]
Secondary outcome measures (2)
- Changes in intestinal ultrasound [Time frame: 3 months after endotherapy]
- Proportion of surgery [Time frame: 1 year after endotherapy]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06165289 · luyi45