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

NCT ID: NCT06165289

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRP high concentration group

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

Group Type EXPERIMENTAL

PRP Injection

Intervention Type OTHER

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

PRP low concentration group

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

Group Type EXPERIMENTAL

PRP Injection

Intervention Type OTHER

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

Interventions

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PRP Injection

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yi Lu

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yi Lu, MD

Role: CONTACT

Phone: +86 02038254116

Email: [email protected]

Other Identifiers

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luyi45

Identifier Type: -

Identifier Source: org_study_id