Endoscopic Submucosal Dissection, Platelet-rich Plasma
Conditions
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.
Interventions
DRUGPlatelet rich plasma
The experimental group was treated with PRP for artificial gastric ulcer after ESD.
DRUGNormal saline
The control group was treated with normal saline for artificial gastric ulcer after ESD.
Sponsors
Keimyung University Dongsan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of artificial gastric ulcer | 2 weeks | Measure the ulcer size with an endoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of artificial gastric ulcer | 4 weeks | Measure the ulcer size with an endoscopy. |
| Occurrence of postprocedure complication | 2 weeks | Postprocedure complications were investigated by patient examination and endoscopy. |
Countries
South Korea
Outcome results
None listed