Clinical Trials Study
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World J Gastroenterol. Jul 28, 2014; 20(28): 9570-9577
Published online Jul 28, 2014. doi: 10.3748/wjg.v20.i28.9570
Safety trial of high-intensity focused ultrasound therapy for pancreatic cancer
Atsushi Sofuni, Fuminori Moriyasu, Takatomo Sano, Fumihide Itokawa, Takayoshi Tsuchiya, Toshio Kurihara, Kentaro Ishii, Syujiro Tsuji, Nobuhito Ikeuchi, Reina Tanaka, Junko Umeda, Ryosuke Tonozuka, Mitsuyoshi Honjo, Shuntaro Mukai, Mitsuru Fujita, Takao Itoi
Atsushi Sofuni, Fuminori Moriyasu, Takatomo Sano, Fumihide Itokawa, Takayoshi Tsuchiya, Toshio Kurihara, Kentaro Ishii, Syujiro Tsuji, Nobuhito Ikeuchi, Reina Tanaka, Junko Umeda, Ryosuke Tonozuka, Mitsuyoshi Honjo, Shuntaro Mukai, Mitsuru Fujita, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo 160-0023, Japan
Author contributions: All authors contributed equally to this manuscript.
Supported by The cancer research project group of Tokyo Medical University
Correspondence to: Atsushi Sofuni, MD, PhD, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan. a-sofuni@amy.hi-ho.ne.jp
Telephone: +81-3-33426111 Fax: +81-3-53816654
Received: December 30, 2013
Revised: February 25, 2014
Accepted: April 30, 2014
Published online: July 28, 2014
Processing time: 208 Days and 2.2 Hours
Abstract

AIM: To evaluate the safety and clinical application of high-intensity focused ultrasound (HIFU) therapy for unresectable pancreatic cancer (PC).

METHODS: Thirty PC patients (16 cases in stage III and 14 cases in stage IV) with visualized pancreatic tumors were admitted for HIFU therapy as an optional local therapy in addition to systemic chemotherapy or chemoradiotherapy. Informed consent was obtained. This study began at the end of 2008 and was approved by the ethics committee of our hospital [Institutional Review Board (IRB): 890]. The HIFU device used was the FEP-BY02 (Yuande Bio-Medical Engineering, Beijing, China).

RESULTS: The mean tumor size after HIFU therapy changed to 30.9 ± 1.7 mm from 31.7 ± 1.7 mm at pre-therapy. There were no significant changes in tumor size, mean number of treatment sessions (2.7 ± 0.1 mm), or mean total treatment time (2.4 ± 0.1 h). The rate of symptom relief effect was 66.7%. The effectiveness of primary lesion treatment was as follows: complete response, 0; partial response, 4; stable disease, 22; progressive disease, 4. Treatment after HIFU therapy included 2 operations, 24 chemotherapy treatments, and 4 best supportive care treatments. Adverse events occurred in 10% of cases, namely pseudocyst formation in 2 cases and mild pancreatitis development in 1. However, no severe adverse events occurred in this study.

CONCLUSION: We suggest that HIFU therapy is safe and has the potential to be a new method of combination therapy for PC.

Keywords: High-intensity focused ultrasound; Pancreatic cancer; Safety trial; Tumor ablation; Ultrasonography

Core tip: The results of chemotherapy and chemoradiotherapy for unresectable pancreatic cancer (PC) have not been satisfactory. Therefore, new advances in therapy are expected. High-intensity focused ultrasound (HIFU), which uses focused ultrasound energy for therapeutic methods such as tissue ablation from an external body, is a new ultrasound technology. HIFU therapy is a new technology therapy for PC. The HIFU device used in this study was the FEP-BY02 (Yuande Bio-Medical Engineering, Beijing, China), which is designed to reduce adverse events. According to the current safety trial, HIFU therapy is non-invasive and promising for clinical effectiveness. HIFU therapy has the potential to be a new method of combination therapy for PC.