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A Novel Absorbable Radiopaque Hydrogel Spacer to Separate the Head of the Pancreas and Duodenum in Radiation Therapy for Pancreatic Cancer.

ABSTRACT: We assessed the feasibility and theoretical dosimetric advantages of an injectable hydrogel to increase the space between the head of the pancreas (HOP) and duodenum in a human cadaveric model.Using 3 human cadaveric specimens, an absorbable radiopaque hydrogel was injected between the HOP and duodenum by way of open laparotomy in 1 case and endoscopic ultrasound (EUS) guidance in 2 cases. The cadavers were subsequently imaged using computed tomography and dissected for histologic confirmation of hydrogel placement. The duodenal dose reduction and planning target volume (PTV) coverage were characterized using pre- and postspacer injection stereotactic body radiation therapy (SBRT) plans for the 2 cadavers with EUS-guided placement, the delivery method that appeared the most clinically desirable. Modeling studies were performed using 60 SBRT plans consisting of 10 previously treated patients with unresectable pancreatic cancer, each with 6 different HOP-duodenum separation distances. The duodenal volume receiving 15 Gy (V15), 20 Gy (V20), and 33 Gy (V33) was assessed for each iteration.In the 3 cadaveric studies, an average of 0.9 cm, 1.1 cm, and 0.9 cm HOP-duodenum separation was achieved. In the 2 EUS cases, the V20 decreased from 3.86 cm3 to 0.36 cm3 and 3.75 cm3 to 1.08 cm3 (treatment constraint <3 cm3), and the V15 decreased from 7.07 cm3 to 2.02 cm3 and 9.12 cm3 to 3.91 cm3 (treatment constraint <9 cm3). The PTV coverage improved or was comparable between the pre- and postinjection studies. Modeling studies demonstrated that a separation of 8 mm was sufficient to consistently reduce the V15, V20, and V33 to acceptable clinical constraints.Currently, dose escalation has been limited owing to radiosensitive structures adjacent to the pancreas. We demonstrated the feasibility of hydrogel separation of the HOP and duodenum. Future studies will evaluate the safety and efficacy of this technique with the potential for more effective dose escalation using SBRT or intensity-modulated radiation therapy to improve the outcomes in patients with unresectable pancreatic cancer.

SUBMITTER: Rao AD

PROVIDER: S-EPMC5699940 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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A Novel Absorbable Radiopaque Hydrogel Spacer to Separate the Head of the Pancreas and Duodenum in Radiation Therapy for Pancreatic Cancer.

Rao Avani D AD Feng Ziwei Z Shin Eun Ji EJ He Jin J Waters Kevin M KM Coquia Stephanie S DeJong Robert R Rosati Lauren M LM Su Lin L Li Dengwang D Jackson Juan J Clark Stephen S Schultz Jeffrey J Hutchings Danielle D Kim Seong-Hun SH Hruban Ralph H RH DeWeese Theodore L TL Wong John J Narang Amol A Herman Joseph M JM Ding Kai K

International journal of radiation oncology, biology, physics 20170814 5

<h4>Purpose</h4>We assessed the feasibility and theoretical dosimetric advantages of an injectable hydrogel to increase the space between the head of the pancreas (HOP) and duodenum in a human cadaveric model.<h4>Methods and materials</h4>Using 3 human cadaveric specimens, an absorbable radiopaque hydrogel was injected between the HOP and duodenum by way of open laparotomy in 1 case and endoscopic ultrasound (EUS) guidance in 2 cases. The cadavers were subsequently imaged using computed tomograp ...[more]

PMID: 28943075

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Project description:PurposePancreatic cancer is the fourth leading cause of cancer-related death, with a very low 5-year overall survival rate (OS). Radiation therapy (RT) together with dose escalation significantly increases the OS at 2 and 3 years. However, dose escalation is very limited due to the proximity of the duodenum. Hydrogel spacers are an effective way to reduce duodenal toxicity, but the complexity of the anatomy and the procedure makes the success and effectiveness of the spacer procedure highly uncertain. To provide a preoperative simulation of hydrogel spacers, we presented a patient-specific spacer simulator algorithm and used it to create a decision support system (DSS) to provide a preoperative optimal spacer location to maximize the spacer benefits.Materials and methodsOur study was divided into three phases. In the validation phase, we evaluated the patient-specific spacer simulator algorithm (FEMOSSA) for the duodenal spacer using the dice similarity coefficient (DSC), overlap volume histogram (OVH), and radial nearest neighbor distance (RNND). For the simulation phase, we simulated four virtual spacer scenarios based on the location of the spacer in para-duodenal space. Next, stereotactic body radiation therapy (SBRT) plans were designed and dosimetrically analyzed. Finally, in the prediction phase, using the result of the simulation phase, we created a Bayesian DSS to predict the optimal spacer location and biological effective dose (BED).ResultsA realistic simulation of the spacer was achieved, reflected in a statistically significant increase in average target and duodenal DSC for the simulated spacer. Moreover, the small difference in average mean and 5th-percentile RNNDs (0.5 and 2.1 mm) and OVH thresholds (average of less than 0.75 mm) showed that the simulation attained similar separation as the real spacer. We found a spacer-location-independent decrease in duodenal V20Gy, a highly spacer-location-dependent change in V33Gy, and a strong correlation between L1cc and V33Gy. Finally, the Bayesian DSS predicted the change in BED with a root mean squared error of 3.6 Gys.ConclusionsA duodenal spacer simulator platform was developed and used to systematically study the dosimetric effect of spacer location. Further, L1cc is an informative anatomical feedback to guide the DSS to indicate the spacer efficacy, optimum location, and expected improvement.

Project description:PurposeTo assess the efficacy of placing a polyethylene glycol (PEG) spacing hydrogel in patients undergoing proton beam radiation therapy for prostate cancer. This study also aims to assess the effect on rectal radiation dose of prostate-rectum separation in various anatomic planes.Methods and materialsSeventy-two consecutive prostate cancer patients undergoing conventionally fractionated pencil beam scanning proton radiation therapy with and without hydrogel placement were compared. Magnetic resonance images taken after hydrogel placement measured prostate-rectum separation and were correlated to rectal dosing and rectal toxicity. Univariate analysis of clinical variables and radiation dosing was conducted using nonparametric Wilcoxon rank-sum test with continuity correction between groups (hydrogel spacer vs controls). Spearman's rank correlation coefficient assessed relationships between the various anatomic dimensions of perirectal space and rectal radiation dosing.ResultsFifty-one patients had hydrogel placement before therapy and 21 did not. There was a 42.2% reduction in rectal dosing (mL3 rectum) in hydrogel patients (P < .001). Increasing midline sagittal lift resulted in a greater mitigation of total rectal dose (P = .031). The degree of prostate surface area coverage on coronal plane did not correlate with further reductions in rectal radiation dose (P = .673). Patients who had PEG hydrogels placed reported more rectal side effects during treatment compared with those patients who did not (35.3% vs 9.5%, P = .061). At median 9.5-month follow-up, there was no difference in reporting of grade ≤2 rectal toxicity between the 2 groups (7.7% vs 7.1%, P = .145).ConclusionsPolyethylene glycol hydrogel placement before pencil proton beam radiation therapy for prostate cancer reduced rectal radiation dose. The most important factor reducing total rectal dose was the degree of sagittal midline separation created by the PEG hydrogel. This is the largest study with the longest follow-up to investigate hydrogel placement in the proton beam radiation setting.

Dataset Information

A Novel Absorbable Radiopaque Hydrogel Spacer to Separate the Head of the Pancreas and Duodenum in Radiation Therapy for Pancreatic Cancer.

Publications

A Novel Absorbable Radiopaque Hydrogel Spacer to Separate the Head of the Pancreas and Duodenum in Radiation Therapy for Pancreatic Cancer.

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