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Enrolling by Invitation

NCT Number: NCT06165289

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRP injection

Other

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

Primary outcomes

  1. restenosis rate

    Time frame: 3 months after endotherapy

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

Secondary outcomes

  1. Changes in intestinal ultrasound

    Time frame: 3 months after endotherapy

    the thickness of the stricture intestinal wall, and the width of the proximal intestinal cavity

  2. Proportion of surgery

    Time frame: 1 year after endotherapy

    The proportion of surgery due to stenosis or perforation

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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