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. We decided to use blood drawn from the patient for injection under the lesion. We 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.
Primary Outcome Measures:
- Duration of the submucosal cushion
Ease of injection
Ability to complete lesion removal
Post-procedure complications [ Time Frame: Immediately after the procedure ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Ability to perform lesion removal
Ability to visualize during the procedure [ Time Frame: Immediately after the procedure ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: |
18 |
| Study Start Date: |
May 2007 |
| Estimated Study Completion Date: |
May 2008 |
| Estimated Primary Completion Date: |
May 2008 (Final data collection date for primary outcome measure) |
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1 Normal saline arm: Active Comparator
Polypectomy with normal saline injected for submucosal cushion creation
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Drug: Normal saline
Normal saline will be injected under the lesion to create submucosal cushion
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2 HPMC arm: Active Comparator
Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion
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Drug: HPMC
Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion
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3 Blood arm: Experimental
Polypectomy after injection of autologous blood
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Drug: Autologous blood injection
Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion
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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. We decided to use blood drawn from the patient for injection under the lesion. We 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.
Purpose
