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

NCT ID: NCT00583466

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-05-31

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.

Conditions

Large Polyps in the Gastrointestinal Tract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 Normal saline arm

Polypectomy with normal saline injected for submucosal cushion creation

Group Type: ACTIVE_COMPARATOR

Normal saline

Intervention Type: DRUG

Normal saline will be injected under the lesion to create submucosal cushion

2 HPMC arm

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

Group Type: ACTIVE_COMPARATOR

HPMC

Intervention Type: DRUG

Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion

3 Blood arm

Polypectomy after injection of autologous blood

Group Type: EXPERIMENTAL

Autologous blood injection

Intervention Type: DRUG

Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion

Interventions

Autologous blood injection

Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion

Intervention Type: DRUG

Normal saline

Normal saline will be injected under the lesion to create submucosal cushion

Intervention Type: DRUG

HPMC

Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Polyps equal or larger than 1 cm

Exclusion Criteria

• Coagulopathy
• Inability to sign informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergey V. Kantsevoy, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

Giday SA, Magno P, Buscaglia JM, Canto MI, Ko CW, Shin EJ, Xia L, Wroblewski LM, Clarke JO, Kalloo AN, Jagannath SB, Kantsevoy SV. Is blood the ideal submucosal cushioning agent? A comparative study in a porcine model. Endoscopy. 2006 Dec;38(12):1230-4. doi: 10.1055/s-2006-944971.

Reference Type: BACKGROUND

PMID: 17163324 (View on PubMed)

Other Identifiers

NA_00008376

Identifier Type: -

Identifier Source: org_study_id