| Registry | NCT03220334 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 20 (Actual) |
| Sponsor | Keimyung University Dongsan Medical Center (Other) |
| Conditions | Platelet-rich Plasma, Endoscopic Submucosal Dissection |
| Interventions | Platelet rich plasma, Normal saline (Drug) |
| Dates | start 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 in South Korea |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 |
Sex: All, ages: 18 Years to any
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 | City | Country | Status |
|---|---|---|---|
| KeimyungUniversity | Daegu, Jung-gu | South Korea |