Clinical trial NCT00583466: Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection
Official title: Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Large Polyps in the Gastrointestinal Tract
Keywords: submucosal cushion
polypectomy
endoscopic mucosal resection
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Polyps equal or larger than 1 cm

Exclusion Criteria:

* Coagulopathy
* Inability to sign informed consent

Primary outcomes:
measure: Duration of the Submucosal Cushion
timeFrame: Immediately after the procedure, Up to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Sergey V. Kantsevoy, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.