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

Sun Yat-sen University

Status: Invitation-only

Conditions: Crohn Disease

Treatments: Other: PRP Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06165289

luyi45

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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74 participants in 2 patient groups

PRP high concentration group

Experimental group

Description:

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

Treatment:

Other: PRP Injection

PRP low concentration group

Experimental group

Description:

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

Treatment:

Other: PRP Injection