TY - JOUR
T1 - Evaluation of a Novel Absorbable Radiopaque Hydrogel in Patients Undergoing Image Guided Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
AU - Rao, Avani Dholakia
AU - Shin, Eun Ji
AU - Meyer, Jeffrey
AU - Thompson, Elizabeth L.
AU - Fu, Wei
AU - Hu, Chen
AU - Fishman, Elliot K.
AU - Weiss, Matthew
AU - Wolfgang, Christopher
AU - Burkhart, Richard
AU - He, Jin
AU - Kerdsirichairat, Tossapol
AU - Herman, Joseph M.
AU - Ding, Kai
AU - Narang, Amol
N1 - Publisher Copyright:
© 2020 American Society for Radiation Oncology
PY - 2020/11/1
Y1 - 2020/11/1
N2 - Purpose: We assessed the feasibility and safety of placing a radiopaque hydrogel in the pancreaticoduodenal groove via endoscopic ultrasound guidance in patients with borderline resectable/locally advanced pancreatic cancer (BR/LAPC). Methods and Materials: Hydrogel injections were done at time of fiducial placement to form blebs in the pancreaticoduodenal groove. Patients subsequently underwent simulation computed tomography (sim-CT) followed by hypofractionated stereotactic body radiotherapy (SBRT; 33 Gy in 5 fractions). Four to 8 weeks after SBRT, patients underwent CT re-evaluation for surgical candidacy and assessment of hydrogel location and size. Hydrogel placement was considered successful if identified in the pancreaticoduodenal groove on sim-CT scan. Stability was evaluated using equivalence testing analyses, with a null hypothesis of the presence of a ≥20% mean percentage change in volume and ≥2 mm change in the median and mean interbleb surface distance with a P value <.05 required to reject the null hypothesis and conclude equivalence. For patients undergoing pancreaticoduodenectomy, hydrogel sites were histologically examined for location and local inflammatory reactions. Results: Hydrogel placement was successful in 6 of the 6 evaluable patients. The average changes in median and mean interbleb distances were −0.43 mm and −0.35 mm, respectively, with P < .05. The average change in volume from sim-CT to post-SBRT CT was −1.0%, with P < .05. One patient experienced grade 3 nausea after fiducial/hydrogel placement, with no other adverse events to date. Conclusions: These data demonstrate feasibility and safety of injecting a hydrogel marker in the pancreaticoduodenal groove in patients with BR/LAPC and set the stage for a follow-up clinical trial to place hydrogel as a spacer between the pancreatic tumor and dose-limiting, radiosensitive duodenum.
AB - Purpose: We assessed the feasibility and safety of placing a radiopaque hydrogel in the pancreaticoduodenal groove via endoscopic ultrasound guidance in patients with borderline resectable/locally advanced pancreatic cancer (BR/LAPC). Methods and Materials: Hydrogel injections were done at time of fiducial placement to form blebs in the pancreaticoduodenal groove. Patients subsequently underwent simulation computed tomography (sim-CT) followed by hypofractionated stereotactic body radiotherapy (SBRT; 33 Gy in 5 fractions). Four to 8 weeks after SBRT, patients underwent CT re-evaluation for surgical candidacy and assessment of hydrogel location and size. Hydrogel placement was considered successful if identified in the pancreaticoduodenal groove on sim-CT scan. Stability was evaluated using equivalence testing analyses, with a null hypothesis of the presence of a ≥20% mean percentage change in volume and ≥2 mm change in the median and mean interbleb surface distance with a P value <.05 required to reject the null hypothesis and conclude equivalence. For patients undergoing pancreaticoduodenectomy, hydrogel sites were histologically examined for location and local inflammatory reactions. Results: Hydrogel placement was successful in 6 of the 6 evaluable patients. The average changes in median and mean interbleb distances were −0.43 mm and −0.35 mm, respectively, with P < .05. The average change in volume from sim-CT to post-SBRT CT was −1.0%, with P < .05. One patient experienced grade 3 nausea after fiducial/hydrogel placement, with no other adverse events to date. Conclusions: These data demonstrate feasibility and safety of injecting a hydrogel marker in the pancreaticoduodenal groove in patients with BR/LAPC and set the stage for a follow-up clinical trial to place hydrogel as a spacer between the pancreatic tumor and dose-limiting, radiosensitive duodenum.
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U2 - 10.1016/j.prro.2020.01.013
DO - 10.1016/j.prro.2020.01.013
M3 - Article
C2 - 32151732
AN - SCOPUS:85084985444
SN - 1879-8500
VL - 10
SP - e508-e513
JO - Practical Radiation Oncology
JF - Practical Radiation Oncology
IS - 6
ER -