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

Primary Purpose

Platelet-rich Plasma, Endoscopic Submucosal Dissection

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Platelet rich plasma

Normal saline

About this trial

This is an interventional treatment trial for Platelet-rich Plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

KeimyungUniversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apply platelet rich plasma to the artificial gastric ulcer

Apply normal saline to the artificial gastric ulcer

Arm Description

Outcomes

Primary Outcome Measures

Recovery of artificial gastric ulcer

Measure the ulcer size with an endoscopy.

Secondary Outcome Measures

Recovery of artificial gastric ulcer

Measure the ulcer size with an endoscopy.

Occurrence of postprocedure complication

Postprocedure complications were investigated by patient examination and endoscopy.

Occurrence of postprocedure complication

Postprocedure complications were investigated by patient examination and endoscopy.

Full Information

NCT ID

NCT03220334

First Posted

July 9, 2017

Last Updated

November 6, 2017

Sponsor

Keimyung University Dongsan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03220334

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

October 31, 2017 (Actual)

Study Completion Date

October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Keimyung University Dongsan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Platelet-rich Plasma, Endoscopic Submucosal Dissection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apply platelet rich plasma to the artificial gastric ulcer

Arm Type

Experimental

Arm Title

Apply normal saline to the artificial gastric ulcer

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Platelet rich plasma

Other Intervention Name(s)

PRP

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Recovery of artificial gastric ulcer

Description

Measure the ulcer size with an endoscopy.

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Recovery of artificial gastric ulcer

Description

Measure the ulcer size with an endoscopy.

Time Frame

4 weeks

Title

Occurrence of postprocedure complication

Description

Postprocedure complications were investigated by patient examination and endoscopy.

Time Frame

2 weeks

Title

Occurrence of postprocedure complication

Description

Postprocedure complications were investigated by patient examination and endoscopy.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

KeimyungUniversity

City

Daegu

State/Province

Jung-gu

ZIP/Postal Code

700-712

Country

Korea, Republic of

12. IPD Sharing Statement

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

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