CC BY-NC-ND 4.0 · Endosc Int Open 2024; 12(07): E861-E867
DOI: 10.1055/a-2286-1995
Original article

EUS-guided hydrogel injection to separate pancreatic head carcinoma from duodenum for enhanced radiotherapy: Multi-site feasibility study

Manoop S. Bhutani
1   Department of Gastroenterology, Hepatology and Nutrition, University of Texas MD Anderson Cancer Center, Houston, United States (Ringgold ID: RIN4002)
,
Amol K. Narang
2   Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, United States (Ringgold ID: RIN1466)
,
Kai Ding
2   Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, United States (Ringgold ID: RIN1466)
,
Brenna Casey
3   Interventional Gastroenterology, Massachusetts General Hospital Harvard Medical School, Boston, United States (Ringgold ID: RIN1855)
,
Kumar Krishnan
4   Gastroenterology, Massachusetts General Hospital, Boston, United States (Ringgold ID: RIN2348)
,
Eugene J. Koay
5   Department of GI Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, United States (Ringgold ID: RIN4002)
,
Theodore S. Hong
6   Radiation Oncology, Massachusetts General Hospital, Boston, United States (Ringgold ID: RIN2348)
,
Joseph M. Herman
7   Department of Radiation Medicine, Northwell, New Hyde Park, United States (Ringgold ID: RIN5799)
,
Kristen H. Griffin
8   Urology, Boston Scientific Corp, Marlborough, United States (Ringgold ID: RIN5724)
,
Eun Ji Shin
9   Internal Medicine, Johns Hopkins Medicine, Baltimore, United States (Ringgold ID: RIN1501)
› Author Affiliations
Supported by: Boston Scientific Corporation

Clinical Trial: Registration number (trial ID): NCT03998566, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Multi-Center Feasibility Study

Abstract

Background and study aims The proximity of a pancreas head tumor to the duodenum often limits delivery of an ablative dose of radiation therapy. This study evaluated the feasibility and safety of using an injectable polyethylene glycol (PEG) hydrogel between the head of the pancreas and duodenum.

Patients and methods In a multi-site feasibility cohort study of patients with localized pancreatic cancer, PEG hydrogel was injected under endoscopic ultrasound guidance to temporarily position the duodenum away from the pancreas. Procedure characteristics were recorded, including hydrogel volume and space created. Patients were monitored for adverse events (AEs) and radiotherapy toxicity.

Results In all six intent-to-treat patients (four with borderline resectable, two with locally advanced disease), the ability to place and visualize PEG hydrogel and create space between the duodenum and the head of the pancreas was successful. There were no procedure-related AEs resulting in radiotherapy delay. There were no device-related AEs and no reports of pancreatitis.

Conclusions PEG hydrogel was successfully placed, created space between the duodenum and the head of the pancreas, and was not associated with major toxicity. Enhancing radiotherapy for pancreatic cancer by using PEG hydrogel to create peri-duodenal space could have beneficial implications for treatment and warrants more exploration.

Supplementary Material



Publication History

Received: 15 November 2023

Accepted after revision: 21 March 2024

Accepted Manuscript online:
25 March 2024

Article published online:
10 July 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clinicians 2019; 69: 7-34
  • 2 American Cancer Society. Cancer Facts & Figures 2020 Atlanta: American Cancer Society. 2020 https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf
  • 3 Thomas TO, Hasan S, Small W. et al. The tolerance of gastrointestinal organs to stereotactic body radiation therapy: what do we know so far?. J Gastrointest Oncol 2014; 5: 236-246
  • 4 Mariados N, Sylvester J, Shah D. et al. Hydrogel spacer prospective multicenter randomized controlled pivotal trial: dosimetric and clinical effects of perirectal spacer application in men undergoing prostate image guided intensity modulated radiation therapy. Int J Radiat Oncol Biol Phys 2015; 92: 971-977
  • 5 Song DY, Herfarth KK, Uhl M. et al. A multi-institutional clinical trial of rectal dose reduction via injected polyethylene-glycol hydrogel during intensity modulated radiation therapy for prostate cancer: analysis of dosimetric outcomes. Int J Radiat Oncol Biol Phys 2013; 87: 81-87
  • 6 Kim SH, Ding K, Rao A. et al. EUS-guided hydrogel microparticle injection in a cadaveric model. J Appl Clin Med Phys 2021; 22: 83-91
  • 7 Rao AD, Shin EJ, Meyer J. et al. Evaluation of a novel absorbable radiopaque hydrogel in patients undergoing image guided radiation therapy for borderline resectable and locally advanced pancreatic adenocarcinoma. Pract Radiat Oncol 2020; 10: e508-e513
  • 8 Alexander A, AjazuddinKhan J. et al. Polyethylene glycol (PEG)–Poly(N-isopropylacrylamide) (PNIPAAm) based thermosensitive injectable hydrogels for biomedical applications. Eur J Pharm Biopharm 2014; 88: 575-585
  • 9 Hatiboglu G, Pinkawa M, Vallée JP. et al. Application technique: placement of a prostate-rectum spacer in men undergoing prostate radiation therapy. BJU Int 2012; 110: E647-E652
  • 10 de Souza Lawrence L, Ford E, Gilbert C. et al. Novel applications of an injectable radiopaque hydrogel tissue marker for management of thoracic malignancies. Chest 2013; 143: 1635-1641
  • 11 Rao AD, Shin EJ, Beck SE. et al. Demonstration of safety and feasibility of hydrogel marking of the pancreas-duodenum interface for image guided radiation therapy (igrt) in a porcine model: implications in igrt for pancreatic cancer patients. Int J Radiat Oncol Biol Phys 2018; 101: 640-645
  • 12 Narang AK, Hong TS, Ding K. et al. A multi-institutional safety and feasibility study exploring the use of hydrogel to create spatial separation between the pancreas and duodenum in patients with pancreatic cancer. Pract Radiat Oncol 2023; 23: 1879-8500
  • 13 Verma V, Lazenby AJ, Zheng D. et al. Dosimetric parameters correlate with duodenal histopathologic damage after stereotactic body radiotherapy for pancreatic cancer: Secondary analysis of a prospective clinical trial. Radiother Oncol 2017; 122: 464-469
  • 14 Burgart LJ, Chopp WV, Jain D. Protocol for the Examination of Specimens from Patients with Carcinoma of the Pancreas, version 4.2.0.0: College of American Pathologists (CAP). 2021 https://documents.cap.org/protocols/Panc.Exo_4.2.0.0.REL_CAPCP.pdf
  • 15 Crane CH, Willett CG. Stereotactic radiotherapy for pancreatic cancer?. Cancer 2009; 115: 468-472
  • 16 Goldsmith C, Plowman PN, Green MM. et al. Stereotactic ablative radiotherapy (SABR) as primary, adjuvant, consolidation and re-treatment option in pancreatic cancer: scope for dose escalation and lessons for toxicity. Radiat Oncol 2018; 13: 204
  • 17 de Geus SWL, Eskander MF, Kasumova GG. et al. Stereotactic body radiotherapy for unresected pancreatic cancer: A nationwide review. Cancer 2017; 123: 4158-4167
  • 18 Tozzi A, Comito T, Alongi F. et al. SBRT in unresectable advanced pancreatic cancer: preliminary results of a mono-institutional experience. Radiat Oncol 2013; 8: 148
  • 19 Ko AH, Crane CH. Radiation therapy in operable and locally advanced pancreatic cancer. J Natl Compr Canc Netw 2010; 8: 1022-1031
  • 20 Koay EJ, Hanania AN, Hall WA. et al. Dose-escalated radiation therapy for pancreatic cancer: a simultaneous integrated boost approach. Pract Radiat Oncol 2020; 10: e495-e507
  • 21 Chang DT, Schellenberg D, Shen J. et al. Stereotactic radiotherapy for unresectable adenocarcinoma of the pancreas. Cancer 2009; 115: 665-672