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

NCT00583466 | Completed Phase 2 Results DMC

• 1 other identifier: NA_00008376
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Large Polyps in the Gastrointestinal Tract

Keywords

submucosal cushion; polypectomy; endoscopic mucosal resection

Outcome Measures

Primary Outcomes (1)

• Duration of the Submucosal Cushion

  Immediately after the procedure, Up to 5 minutes

Study Arms (3)

1 Normal saline arm

ACTIVE COMPARATOR

Polypectomy with normal saline injected for submucosal cushion creation

Drug: Normal saline

2 HPMC arm

ACTIVE COMPARATOR

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

Drug: HPMC

3 Blood arm

EXPERIMENTAL

Polypectomy after injection of autologous blood

Drug: Autologous blood injection

Interventions

Autologous blood injection DRUG

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

3 Blood arm

Normal saline DRUG

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

1 Normal saline arm

HPMC DRUG

Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion

2 HPMC arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Polyps equal or larger than 1 cm

You may not qualify if:

• Coagulopathy
• Inability to sign informed consent

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 17163324 BACKGROUND

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Johns Hopkins ClinicalTrials.gov Program
• Organization: Johns Hopkins University

registerclinicaltrials@jhmi.edu

410-550-6484

Study Officials

• Sergey V. Kantsevoy, M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 13, 2017
• Results First Posted: September 13, 2017

Record last verified: 2017-09

Locations

US (1)