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

Study Overview
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Brief Summary
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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. 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
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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. 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.

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

Conditions
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Large Polyps in the Gastrointestinal Tract

Intervention / Treatment
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* Drug: Autologous blood injection
* Drug: Normal saline
* Drug: HPMC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Polyps equal or larger than 1 cm Exclusion Criteria: Coagulopathy Inability to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Normal saline arm<br>Polypectomy with normal saline injected for submucosal cushion creation | Drug: Normal saline<br>* Normal saline will be injected under the lesion to create submucosal cushion<br>|
| Active Comparator: 2 HPMC arm<br>Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion | Drug: HPMC<br>* Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion<br>|
| Experimental: 3 Blood arm<br>Polypectomy after injection of autologous blood | Drug: Autologous blood injection<br>* Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the Submucosal Cushion |  | Immediately after the procedure, Up to 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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submucosal cushion, polypectomy, endoscopic mucosal resection