Clinical Trials Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Jul 15, 2020; 12(7): 768-781
Published online Jul 15, 2020. doi: 10.4251/wjgo.v12.i7.768
Endoscopic ultrasound-guided fiducial marker placement for neoadjuvant chemoradiation therapy for resectable pancreatic cancer
Reiko Ashida, Nobuyasu Fukutake, Ryoji Takada, Tatsuya Ioka, Kazuyoshi Ohkawa, Kazuhiro Katayama, Hirofumi Akita, Hidenori Takahashi, Shingo Ohira, Teruki Teshima
Reiko Ashida, Tatsuya Ioka, Department of Cancer Survey and Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka 541-8567, Japan
Nobuyasu Fukutake, Ryoji Takada, Kazuyoshi Ohkawa, Kazuhiro Katayama, Department of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer Institute, Osaka 541-8567, Japan
Hirofumi Akita, Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka 565-0871, Japan
Hidenori Takahashi, Department of Surgery, Osaka International Cancer Institute, Osaka 541-8567, Japan
Shingo Ohira, Teruki Teshima, Department of Radiation Oncology, Osaka International Cancer Institute, Osaka 541-8567, Japan
Author contributions: Ashida R and Fukutake N designed the research; Ashida R, Fukutake N, Takada R, Ioka T, Ohkawa K, Katayama K, Akita H, Takahashi H, Ohira S and Teshima T performed the research; Teshima T contributed the grant; Ashida R, Fukutake N and Ohira S analyzed the data; Ashida R wrote the paper; All authors have read and agreed to the final manuscript.
Supported by the JSPS KAKENHI Grant [Grant-in Aid for Scientific Research (B)], No. 15H04913.
Institutional review board statement: The protocol of this study was approved by the Osaka International Cancer Institute Institutional Review Board.
Clinical trial registration statement: This registration policy applies to the prospective study only.
Informed consent statement: All study participants, or their legal guardians, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Tatsuya Ioka received an advisor’s role and speaker’s fee from Taiho Pharmaceutical, and he also received a speaker’s fee from Yakult Honsha. The other authors declare no conflict of interests for this paper.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Reiko Ashida, MD, PhD, Attending Doctor, Department of Cancer Survey and Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan. rashida@goo.jp
Received: February 3, 2020
Peer-review started: February 3, 2020
First decision: March 24, 2020
Revised: April 13, 2020
Accepted: May 12, 2020
Article in press: May 12, 2020
Published online: July 15, 2020
Processing time: 163 Days and 6 Hours
ARTICLE HIGHLIGHTS
Research background

Preoperative neoadjuvant chemoradiation therapy (NACRT) is applied for resectable pancreatic cancer (RPC). To maximize the efficacy of NACRT, it is essential to ensure the accurate placement of fiducial markers for image-guided radiation. However, no standard method for delivering fiducial markers has been established.

Research motivation

For the accurate placement of fiducial markers, endoscopic ultrasound-guided fiducial marker placement (EUS-FP) have been published for unresectable locally advanced PC or borderline RPC showing promising results. However, there is no study that has focused only on RPC. Therefore, the present study focused on the feasibility and safety of EUS-FP for RPC undergoing NACRT as well as the nature of RPC during NACRT.

Research objectives

A total of 29 patients (18 males, 11 females) with pathologically confirmed resectable adenocarcinoma with unclear margin for NACRT were referred for EUS-FP.

Research methods

Under EUS guidance, a single gold marker was placed into the tumor using either a 19- or 22-gauge fine-needle aspiration needle. The differences in daily marker positioning were measured by comparing simulation computed tomography and treatment computed tomography.

Research results

In all 29 patients (100%) who underwent EUS-FP, fiducials were placed successfully with only minor, self-limiting bleeding during puncture observed in 2 patients (6.9%). NACRT was subsequently administered to all patients and completed in 28/29 (96.6%) cases, with one patient experiencing repeat cholangitis. Spontaneous migration of gold markers was observed in 1 patient. Twenty-four patients (82.8%) had surgery with 91.7% (22/24) R0 resection, and two patients experienced complete remission. No inflammatory changes around the marker were observed in the surgical specimen. The daily position of gold markers showed large positional changes, particularly in the superior-inferior direction. Moreover, tumor location was affected by food and fluid intake as well as bowel gas, which changes daily.

Research conclusions

EUS-FP for RPC not only has a high technical success rate and a very low complication rate, it provides accurate tumor location information during daily radiation therapy.

Research perspectives

A prospective randomized controlled study with a larger sample size of patients is needed to further evaluate the role EUS-FP following NACRT for RPC.