Evaluation of the Efficacy of Platelet-rich Plasma (PRP) on Advanced Endoscopic Resection Techniques

NCT ID: NCT02931149

Last Updated: 2018-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Platelet-rich Plasma Endoscopic Mucosal Resection Endoscopic Submucosal Dissection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Submucosal injection with PRP

All participants in the study received submucosal injection of PRP prior to endoscopic resection

Group Type EXPERIMENTAL

Platelet-rich plasma

Intervention Type DRUG

Submucosal injection with PRP was performed prior to endoscopic resection

Interventions

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Platelet-rich plasma

Submucosal injection with PRP was performed prior to endoscopic resection

Intervention Type DRUG

Other Intervention Names

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PRP

Eligibility Criteria

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Inclusion Criteria

* Endoscopic lesion higher than 40mm in diameter submitted to endoscopic resection (EMR or eSD)

Exclusion Criteria

* Ineligibility to endoscopic resection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Germans Trias i Pujol Hospital

OTHER

Sponsor Role lead

Responsible Party

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Vicente Lorenzo-Zúñiga García

Study Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vicente Lorenzo-Zúñiga García, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Germans Trias

Locations

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Endoscopy Unit. University Hospital Germans Trias

Badalona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 27540573 (View on PubMed)

Other Identifiers

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EndoPRP2016

Identifier Type: -

Identifier Source: org_study_id

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