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

Platelet-rich Plasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03220334
• Other study ID #: 12-181
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2017
• Last updated: November 6, 2017
• Start date: June 1, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: November 2017
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Submucosal Dissection
• Platelet-rich Plasma
• Stomach Ulcer

Intervention

Drug:
• Platelet rich plasma
The experimental group was treated with PRP for artificial gastric ulcer after ESD.
• Normal saline
The control group was treated with normal saline for artificial gastric ulcer after ESD.

Locations

Country	Name	City	State
Korea, Republic of	KeimyungUniversity	Daegu	Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of artificial gastric ulcer	Measure the ulcer size with an endoscopy.	2 weeks
Secondary	Recovery of artificial gastric ulcer	Measure the ulcer size with an endoscopy.	4 weeks
Secondary	Occurrence of postprocedure complication	Postprocedure complications were investigated by patient examination and endoscopy.	2 weeks
Secondary	Occurrence of postprocedure complication	Postprocedure complications were investigated by patient examination and endoscopy.	4 weeks