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OpenTrials
Completed

NCT Number: NCT03220334

Healing Effects of Autologous Platelet Rich Plasma on Gastric Ulcer Caused by Endoscopic Submucosal Dissection

In Korea, where the prevalence of gastric tumors is high, the use of ESD as a treatment for gastric cancer will continue to increase. Considering that there are no special measures to prevent side effects (bleeding, perforation, etc.) of this procedure, it is possible to reduce the large medical costs through the discovery of substances that can promote gastric mucosal healing. Mechanism of PRP-based materials in the regeneration of gastric mucosal damage can be used to understand the pathophysiology of ulcers. In the future, it can be suggested as a new treatment for gastrointestinal tract damage such as intractable ulcer, perforation, mucosal fistula, gastrointestinal bleeding caused by esophagus, small intestine and large intestine as well as ulcer treatment by endoscopic procedure.

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Key information

Conditions

Platelet-Rich Plasma Endoscopic Submucosal Dissection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

KeimyungUniversity

Daegu, Jung-gu, 700-712, South Korea

About this study

Background:In Korea, where the prevalence of gastric tumors is high, the use of ESD as a treatment for gastric cancer will continue to increase. Considering that there are no special measures to prevent side effects (bleeding, perforation, etc.) of this procedure, it is possible to reduce the large medical costs through the discovery of substances that can promote gastric mucosal healing. Platelet-rich plasma (PRP) has demonstrated efficacy in preclinical endoscopic resection models.

Aim: Evaluate the efficacy of PRP on participants submitted to ESD.

Material and Methods: The investigators have evaluated a prospective clinical study. The investigators have included 10 participants submitted to ESD. Patients were informed and accepted to participate with a written consent. Prior to endoscopy PRP was obtained from autologous blood with a commercial kit. Resection was performed with standard technique. Immediately after the procedure, autologous PRP is applied to the artificial gastric ulcer using endoscopic spray. Participants were followed-up after the procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Endoscopic lesion submitted to endoscopic resection (ESD)

Exclusion criteria

  • Ineligibility to endoscopic resection
  • Patients who declined to participate in this study
  • Patients who had hematologic diseases

Treatment and study plan

Platelet rich plasma

Drug

The experimental group was treated with PRP for artificial gastric ulcer after ESD.

Other names: PRP

normal saline

Drug

The control group was treated with normal saline for artificial gastric ulcer after ESD.

Primary outcomes

  1. Recovery of artificial gastric ulcer

    Time frame: 2 weeks

    Measure the ulcer size with an endoscopy.

Secondary outcomes

  1. Recovery of artificial gastric ulcer

    Time frame: 4 weeks

    Measure the ulcer size with an endoscopy.

  2. Occurrence of postprocedure complication

    Time frame: 2 weeks

    Postprocedure complications were investigated by patient examination and endoscopy.

  3. Occurrence of postprocedure complication

    Time frame: 4 weeks

    Postprocedure complications were investigated by patient examination and endoscopy.

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2017
Registry last updated
Nov 7, 2017

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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