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
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
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
Start Date: May 2007
Completed Date: May 2008
Phase: Phase 2
Primary Outcome: Duration of the Submucosal Cushion
Study sponsors, principal investigator, and references
Principal Investigator: Sergey V. Kantsevoy, M.D., Ph.D.
Lead Sponsor: Johns Hopkins University
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.