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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06165289
• Other study ID #: luyi45
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Yi Lu, MD
• Phone: +86 02038254116
• Email: luyi45[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed as CD;
• Stenosis of the colon was found during colonoscopy, and surgery was not considered for the time being; ? Imaging stenosis was found, that is, CTE suggested stenosis with proximal intestinal dilatation >3cm;
• Narrow length <5cm; ? 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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• PRP Injection
Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with different concerntrations

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	restenosis rate	restenosis means the endoscopy with size of 10.5mm can not pass the stricture afer endotherapy	3 months after endotherapy
Secondary	Changes in intestinal ultrasound	the thickness of the stricture intestinal wall, and the width of the proximal intestinal cavity	3 months after endotherapy
Secondary	Proportion of surgery	The proportion of surgery due to stenosis or perforation	1 year after endotherapy