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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00583466
First received: December 20, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Large Polyps in the Gastrointestinal Tract
Drug: Autologous blood injection
Drug: Normal saline
Drug: HPMC
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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)
Arms Assigned Interventions
Active Comparator: 1 Normal saline arm
Polypectomy with normal saline injected for submucosal cushion creation
Drug: Normal saline
Normal saline will be injected under the lesion to create submucosal cushion
Active Comparator: 2 HPMC arm
Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion
Drug: HPMC
Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion
Experimental: 3 Blood arm
Polypectomy after injection of autologous blood
Drug: Autologous blood injection
Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Polyps equal or larger than 1 cm

Exclusion Criteria:

  • Coagulopathy
  • Inability to sign informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583466

Contacts
Contact: Sergey V Kantsevoy, M.D., Ph.D 410-614-6708 svkan@jhmi.edu
Contact: Samuel A Giday, M.D. 410-614-6708 sgiday1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Sergey V. Kantsevoy, M.D., Ph.D.    410-614-6708    svkan@jhmi.edu   
Contact: Samuel A. Giday, M.D.    410-614-6708    sgiday1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Sergey V. Kantsevoy, M.D., Ph.D. Johns Hopkins University
  More Information

Publications:
Responsible Party: Sergey V. Kantsevoy, M.D., Ph.D., Associate Professor of Medicine, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00583466     History of Changes
Other Study ID Numbers: NA_00008376
Study First Received: December 20, 2007
Last Updated: December 20, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
submucosal cushion
polypectomy
endoscopic mucosal resection

Additional relevant MeSH terms:
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014