title: Safety trial of high-intensity focused ultrasound therapy for pancreatic cancer.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  We suggest that HIFU therapy is safe and has the potential to be a new method of combination therapy for PC.
authors: 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.
authors: Atsushi
authors: A
authors: Sofuni
authors: 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.
authors: Fuminori
authors: F
authors: Moriyasu
authors: 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.
authors: Takatomo
authors: T
authors: Sano
authors: 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.
authors: Fumihide
authors: F
authors: Itokawa
authors: 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.
authors: Takayoshi
authors: T
authors: Tsuchiya
authors: 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.
authors: Toshio
authors: T
authors: Kurihara
authors: 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.
authors: Kentaro
authors: K
authors: Ishii
authors: 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.
authors: Syujiro
authors: S
authors: Tsuji
authors: 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.
authors: Nobuhito
authors: N
authors: Ikeuchi
authors: 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.
authors: Reina
authors: R
authors: Tanaka
authors: 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.
authors: Junko
authors: J
authors: Umeda
authors: 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.
authors: Ryosuke
authors: R
authors: Tonozuka
authors: 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.
authors: Mitsuyoshi
authors: M
authors: Honjo
authors: 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.
authors: Shuntaro
authors: S
authors: Mukai
authors: 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.
authors: Mitsuru
authors: M
authors: Fujita
authors: 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.
authors: Takao
authors: T
authors: Itoi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017024:Chemotherapy, Adjuvant; D005260:Female; D057086:High-Intensity Focused Ultrasound Ablation / Q000009:adverse effects; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010180:Pancreatectomy; D010190:Pancreatic Neoplasms / Q000473:pathology / Q000601:surgery*; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D013997:Time Factors; D016896:Treatment Outcome; D047368:Tumor Burden
keywords: High-intensity focused ultrasound; Pancreatic cancer; Safety trial; Tumor ablation; Ultrasonography