Endoscopic Balloon Dilatation Combined With PRP Injection in Colonic Stenosis in Crohn's Disease (NCT06165289) | Clinical Trial Compass
By InvitationNot Applicable
Endoscopic Balloon Dilatation Combined With PRP Injection in Colonic Stenosis in Crohn's Disease
China74 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
restenosis rate
Timeframe: 3 months after endotherapy
Trial details
NCT IDNCT06165289
SponsorSixth Affiliated Hospital, Sun Yat-sen University