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

Phase 3

Completed

• Conditions: Endoscopic Submucosal Dissection; Platelet-rich Plasma; Endoscopic Mucosal Resection
• Interventions: Drug: Platelet-rich plasma

• Registration Number: NCT02931149
• Lead Sponsor: Germans Trias i Pujol Hospital

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.

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

• Ineligibility to endoscopic resection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Submucosal injection with PRP	Platelet-rich plasma	All participants in the study received submucosal injection of PRP prior to endoscopic resection

Primary Outcome Measures

Name	Time	Method
Prevention of delayed bleeding: percentage of participants with delayed bleeding	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	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

Trial Locations

Locations (1)

Endoscopy Unit. University Hospital Germans Trias; 🇪🇸 Badalona, Barcelona, Spain