Evaluation of the Efficacy of Platelet-rich Plasma (PRP) on Advanced Endoscopic Resection Techniques
1 other identifier
interventional
11
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2016
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFebruary 14, 2018
February 1, 2018
6 months
October 7, 2016
February 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prevention of delayed bleeding: percentage of participants with delayed bleeding
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
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
Study Arms (1)
Submucosal injection with PRP
EXPERIMENTALAll participants in the study received submucosal injection of PRP prior to endoscopic resection
Interventions
Submucosal injection with PRP was performed prior to endoscopic resection
Eligibility Criteria
You may qualify if:
- Endoscopic lesion higher than 40mm in diameter submitted to endoscopic resection (EMR or eSD)
You may not qualify if:
- Ineligibility to endoscopic resection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Endoscopy Unit. University Hospital Germans Trias
Badalona, Barcelona, 08916, Spain
Related Publications (1)
Lorenzo-Zuniga V, Boix J, Moreno de Vega V, Bon I, Marin I, Bartoli R. Efficacy of platelet-rich plasma as a shielding technique after endoscopic mucosal resection in rat and porcine models. Endosc Int Open. 2016 Aug;4(8):E859-64. doi: 10.1055/s-0042-109170. Epub 2016 Aug 10.
PMID: 27540573RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Vicente Lorenzo-Zúñiga García, M.D., Ph.D.
University Hospital Germans Trias
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
October 7, 2016
First Posted
October 12, 2016
Study Start
August 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
February 14, 2018
Record last verified: 2018-02