TY - JOUR
T1 - Injectable drug-eluting elastomeric polymer
T2 - A novel submucosal injection material
AU - Tran, Richard T.
AU - Palmer, Michael
AU - Tang, Shou Jiang
AU - Abell, Thomas L.
AU - Yang, Jian
N1 - Funding Information:
DISCLOSURE: The authors disclosed no financial relationships relevant to this publication. This work was supported in part by a R21 award ( EB009795 ) (to J.Y.) and a R01 award ( 1R01EB012575-01A1 ) (to J.Y.) from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), and a National Science Foundation CAREER award 0954109 (to J.Y.).
PY - 2012/5
Y1 - 2012/5
N2 - 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. Design: Comparative study of 3 different solutions by using material characterization tests and ex vivo and in vivo porcine models. Setting: Academic hospital. Interventions: 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. Main Outcome Measurements: 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. Limitations: 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.
AB - 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. Design: Comparative study of 3 different solutions by using material characterization tests and ex vivo and in vivo porcine models. Setting: Academic hospital. Interventions: 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. Main Outcome Measurements: 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. Limitations: 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.
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U2 - 10.1016/j.gie.2011.12.009
DO - 10.1016/j.gie.2011.12.009
M3 - Article
C2 - 22301346
AN - SCOPUS:84862792993
SN - 0016-5107
VL - 75
SP - 1092
EP - 1097
JO - Gastrointestinal Endoscopy
JF - Gastrointestinal Endoscopy
IS - 5
ER -