- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02931149
Evaluation of the Efficacy of Platelet-rich Plasma (PRP) on Advanced Endoscopic Resection Techniques
Study Overview
Status
Intervention / Treatment
Detailed Description
Background:To avoid complications secondary to advanced endoscopic resection techniques (Endoscopic Mucosal Resection -EMR- or Endoscopic Submucosal Disection -ESD-) the endoscopists have to avoid deep thermal damage and increase mucosal healing. Platelet-rich plasma (PRP) has demonstrated efficacy in preclinical endoscopic resection models.
Aim: Evaluate the efficacy of PRP on participants submitted to advanced endoscopic resection techniques: EMR or ESD.
Material and Methods: The investigators have evaluated a prospective clinical study. The investigators have included 12 participants submitted to EMR or ESD. Patients were informed and accepted to participate with a written consent. Prior to endoscopy PRP was obtained from autologous blood with a comercial kit. Submucosal injection with PRP were performed prior to resection. Resection was performed with standard technique. Participants were followed-up after the procedure.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Barcelona
-
Badalona, Barcelona, Spain, 08916
- Endoscopy Unit. University Hospital Germans Trias
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Endoscopic lesion higher than 40mm in diameter submitted to endoscopic resection (EMR or eSD)
Exclusion Criteria:
- Ineligibility to endoscopic resection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Submucosal injection with PRP
All participants in the study received submucosal injection of PRP prior to endoscopic resection
|
Submucosal injection with PRP was performed prior to endoscopic resection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevention of delayed bleeding: percentage of participants with delayed bleeding
Time Frame: 28 days after resection
|
Delayed bleeding occurs between 13-15% of patients submitted to advanced resection techniques.
The aim of this study is to evaluate the efficacy of PRP in the prevention of this complication
|
28 days after resection
|
Prevention of coagulation syndrome (or postpolipectomy syndrome): percentage of participants with coagulation syndrome
Time Frame: 5 days after resection
|
Coagulation syndrome occurs in around 5-7% of patients submitted to EMR or ESD.
The aim is to evaluate the efficacy of PRP in the prevention of this complication
|
5 days after resection
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vicente Lorenzo-Zúñiga García, M.D., Ph.D., University Hospital Germans Trias
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EndoPRP2016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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