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

Study Overview
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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.

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

Conditions
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Platelet-rich Plasma, Endoscopic Submucosal Dissection

Intervention / Treatment
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* Drug: Platelet rich plasma
* Drug: Normal saline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apply platelet rich plasma to the artificial gastric ulcer<br> | Drug: Platelet rich plasma<br>* The experimental group was treated with PRP for artificial gastric ulcer after ESD.<br>* Other names: PRP;|
| Placebo Comparator: Apply normal saline to the artificial gastric ulcer<br> | Drug: Normal saline<br>* The control group was treated with normal saline for artificial gastric ulcer after ESD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of artificial gastric ulcer | Measure the ulcer size with an endoscopy. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of artificial gastric ulcer | Measure the ulcer size with an endoscopy. | 4 weeks | 
| Occurrence of postprocedure complication | Postprocedure complications were investigated by patient examination and endoscopy. | 2 weeks | 
| Occurrence of postprocedure complication | Postprocedure complications were investigated by patient examination and endoscopy. | 4 weeks |