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

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.

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Key information

Conditions

Platelet-Rich Plasma Endoscopic Mucosal Resection Endoscopic Submucosal Dissection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Endoscopy Unit. University Hospital Germans Trias

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Ineligibility to endoscopic resection

Treatment and study plan

platelet-rich plasma

Drug

Submucosal injection with PRP was performed prior to endoscopic resection

Other names: PRP

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Oct 12, 2016
Registry last updated: Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed