Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection

Phase 2

Completed

• Conditions: Large Polyps in the Gastrointestinal Tract
• Interventions: Drug: Autologous blood injection; Drug: Normal saline; Drug: HPMC

• Registration Number: NCT00583466
• Lead Sponsor: Johns Hopkins University

Brief Summary

For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation.

Detailed Description

For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators decided to use blood drawn from the patient for injection under the lesion. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation. Blood can also have local hemostatic action preventing from bleeding during polypectomy.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-31
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2017-08-11
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-11
• Last Update Submitted: 2017-09-11
• Results First Posted: 2017-09-13
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Polyps equal or larger than 1 cm

Exclusion Criteria

• Coagulopathy
• Inability to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 Blood arm	Autologous blood injection	Polypectomy after injection of autologous blood
1 Normal saline arm	Normal saline	Polypectomy with normal saline injected for submucosal cushion creation
2 HPMC arm	HPMC	Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion

Primary Outcome Measures

Name	Time	Method
Duration of the Submucosal Cushion	Immediately after the procedure, Up to 5 minutes

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States