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

NCT ID: NCT03220334

Last Updated: 2017-11-07

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Platelet-rich Plasma Endoscopic Submucosal Dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Apply platelet rich plasma to the artificial gastric ulcer

Group Type EXPERIMENTAL

Platelet rich plasma

Intervention Type DRUG

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

Apply normal saline to the artificial gastric ulcer

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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Platelet rich plasma

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Other Intervention Names

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PRP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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YooJin Lee

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KeimyungUniversity

Daegu, Jung-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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12-181

Identifier Type: -

Identifier Source: org_study_id