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

NCT06165289 | Enrolling By Invitation DMC

• 1 other identifier: luyi45
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• restenosis rate

  restenosis means the endoscopy with size of 10.5mm can not pass the stricture afer endotherapy

  3 months after endotherapy

Secondary Outcomes (2)

• Changes in intestinal ultrasound

  3 months after endotherapy

• Proportion of surgery

  1 year after endotherapy

Study Arms (2)

PRP high concentration group

EXPERIMENTAL

Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with high concentration (platlet 2\*10\^6/μL)

Other: PRP Injection

PRP low concentration group

EXPERIMENTAL

Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with low concentration (platlet 1\*10\^6/μL)

Other: PRP Injection

Interventions

PRP Injection OTHER

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

PRP high concentration group; PRP low concentration group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)