NCT03220334

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Keimyung University Dongsan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Platelet-rich Plasma
• Endoscopic Submucosal Dissection

Interventions

Type	Name	Description
DRUG	Platelet rich plasma	The experimental group was treated with PRP for artificial gastric ulcer after ESD.
DRUG	Normal saline	The control group was treated with normal saline for artificial gastric ulcer after ESD.

Timeline

• Start date: 2017-06-01
• Primary completion: 2017-10-31
• Completion: 2017-10-31
• First posted: 2017-07-18
• Last updated: 2017-11-07

Locations

1 site across 1 country: South Korea