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

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Large Polyps in the Gastrointestinal Tract

Treatments: Drug: Normal saline; Drug: Autologous blood injection; Drug: HPMC

Study type: Interventional

Funder types: Other

Identifiers

NCT00583466

NA_00008376

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Polyps equal or larger than 1 cm

Exclusion criteria

• Coagulopathy
• Inability to sign informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

1 Normal saline arm

Active Comparator group

Description:

Polypectomy with normal saline injected for submucosal cushion creation

Treatment:

Drug: Normal saline

2 HPMC arm

Active Comparator group

Description:

Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion

Treatment:

Drug: HPMC

3 Blood arm

Experimental group

Description:

Polypectomy after injection of autologous blood

Treatment:

Drug: Autologous blood injection