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

Platelet-rich Plasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931149
• Other study ID #: EndoPRP2016
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2016
• Last updated: February 13, 2018
• Start date: August 2016
• Est. completion date: February 2017

Study information

• Verified date: February 2018
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Ineligibility to endoscopic resection

Related Conditions & MeSH terms

• Endoscopic Mucosal Resection
• Endoscopic Submucosal Dissection
• Platelet-rich Plasma

Intervention

Drug:
• Platelet-rich plasma
Submucosal injection with PRP was performed prior to endoscopic resection

Locations

Country	Name	City	State
Spain	Endoscopy Unit. University Hospital Germans Trias	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Lorenzo-Zúñiga V, Boix J, Moreno de Vega V, Bon I, Marín I, Bartolí 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-0042-1091 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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