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Large Polyps in the Gastrointestinal Tract | Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection

Large Polyps in the Gastrointestinal Tract research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Large Polyps in the Gastrointestinal Tract

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

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

Drug:HPMCHydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1 Normal saline armPolypectomy with normal saline injected for submucosal cushion creation

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

3 Blood armPolypectomy after injection of autologous blood

Study Status

Completed

Start Date: May 2007

Completed Date: May 2008

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Duration of the Submucosal Cushion

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Sergey V. Kantsevoy, M.D., Ph.D.

Lead Sponsor: Johns Hopkins University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00583466

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.

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