Injectable drug-eluting elastomeric polymer: a novel submucosal injection material.
BACKGROUND
Biodegradable hydrogels can deliver therapeutic payloads with great potentials in EMR and endoscopic submucosal dissection (ESD) to yield improvements in efficacy and foster mucosal regeneration.


OBJECTIVE
To assess the efficacy of an injectable drug-eluting elastomeric polymer (iDEEP) as a submucosal injection material.


METHODS
Comparative study of 3 different solutions by using material characterization tests and ex vivo and in vivo porcine models.


METHODS
Academic hospital.


METHODS
Thirty gastric submucosal cushions were achieved with saline solution (0.9%), sodium hyaluronate (0.4%), and iDEEP (n = 10) in ex vivo porcine stomachs. Four porcine gastric submucosal cushions were then created in vivo by using iDEEP.


METHODS
Maximum injection pressure, rebamipide release rate, submucosal elevation duration, and assessment of in vivo efficacy by en bloc resection.


RESULTS
No significant difference in injection pressures between iDEEP (28.9 ± 0.3 psi) and sodium hyaluronate (29.5 ± 0.4 psi, P > .05) was observed. iDEEP gels displayed a controlled release of rebamipide up to 2 weeks in vitro. The elevation height of iDEEP (5.7 ± 0.5 mm) was higher than that of saline solution (2.8 ± 0.2 mm, P < .01) and sodium hyaluronate (4.2 ± 0.2 mm, P < .05). All EMR procedures were successfully performed after injection of iDEEP, and a large gel cushion was noted after the resection procedure.


CONCLUSIONS
Benchtop, ex vivo, and nonsurvival pig study.


CONCLUSIONS
A novel injection solution was evaluated for endoscopic resection. These results suggest that iDEEP may provide a significant step toward the realization of an ideal EMR and endoscopic submucosal dissection injection material.
Department of Bioengineering, The University of Texas at Arlington, 500 UTA Boulevard, Arlington, TX 76010-0138, USA.
Richard T
RT
Tran
Michael
M
Palmer
Shou-Jiang
SJ
Tang
Thomas L
TL
Abell
Jian
J
Yang
D000409:Alanine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000818:Animals; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D004337:Drug Carriers / Q000008:administration & dosage*; D005753:Gastric Mucosa / Q000601:surgery*; D006820:Hyaluronic Acid / Q000008:administration & dosage; D020100:Hydrogels / Q000008:administration & dosage*; D015552:Injections, Intralesional; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011312:Pressure; D015363:Quinolones / Q000008:administration & dosage; D012965:Sodium Chloride / Q000008:administration & dosage; D013552:Swine
D000897:Anti-Ulcer Agents; D004337:Drug Carriers; D020100:Hydrogels; D015363:Quinolones; C574868:polyethylene glycol maleate citrate; D011092:Polyethylene Glycols; D012965:Sodium Chloride; D006820:Hyaluronic Acid; C052785:rebamipide; D000409:Alanine