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

Not Applicable

Not yet recruiting

• Conditions: Crohn Disease
• Interventions: Other: PRP Injection

• Registration Number: NCT06165289
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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 (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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Last Update Submitted: 2023-12-01
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11
• Study Start: 2023-12-15
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Diagnosed as CD;

  • Stenosis of the colon was found during colonoscopy, and surgery was not considered for the time being; ③ Imaging stenosis was found, that is, CTE suggested stenosis with proximal intestinal dilatation >3cm;

    • Narrow length <5cm; ⑤ 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;

      ④ Foreign patients;

      ⑤ Patients with a history of malignant tumors, including melanoma (except local skin cancer);

      ⑥ Pregnant or nursing patients;

      ⑦ Patients who could not be followed at all nodes of the primary outcome indicator; Other diseases that researchers believe could put patients at risk;

      ⑧ Other diseases that researchers believe could put patients at risk.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRP high concentration group	PRP Injection	Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with high concentration (platlet 2\*10\^6/μL)
PRP low concentration group	PRP Injection	Endoscopic balloon dilatation combined with autologous platelet-rich plasma (PRP) injection with low concentration (platlet 1\*10\^6/μL)

Primary Outcome Measures

Name	Time	Method
restenosis rate	3 months after endotherapy	restenosis means the endoscopy with size of 10.5mm can not pass the stricture afer endotherapy

Secondary Outcome Measures

Name	Time	Method
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