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.

Study Overview

• Status: Completed
• Conditions: Endoscopic Submucosal Dissection; Platelet-rich Plasma
• Intervention / Treatment: Drug: Platelet rich plasma; Drug: Normal saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jung-gu
    • Daegu, Jung-gu, Korea, Republic of, 700-712
      • KeimyungUniversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: July 9, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Stomach Ulcer
• Other Study ID Numbers: 12-181

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No