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

NCT03220334 | Completed Phase 3

• 1 other identifier: 12-181
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet-rich Plasma; Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

• Recovery of artificial gastric ulcer

  Measure the ulcer size with an endoscopy.

  2 weeks

Secondary Outcomes (3)

• Recovery of artificial gastric ulcer

  4 weeks

• Occurrence of postprocedure complication

  2 weeks

• Occurrence of postprocedure complication

  4 weeks

Study Arms (2)

Apply platelet rich plasma to the artificial gastric ulcer

EXPERIMENTAL

Drug: Platelet rich plasma

Apply normal saline to the artificial gastric ulcer

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

Platelet rich plasma DRUG

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

Also known as: PRP

Apply platelet rich plasma to the artificial gastric ulcer

Normal saline DRUG

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

Apply normal saline to the artificial gastric ulcer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endoscopic lesion submitted to endoscopic resection (ESD)

You may not qualify if:

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

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead

Study Sites (1)

KeimyungUniversity

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

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 9, 2017
• First Posted: July 18, 2017
• Study Start: June 1, 2017
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

KR (1)