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Eto K.,Tomakomai City Hospital | Kawakami H.,Hokkaido University | Haba S.,Nippon Telegraph and Telephone | Yamato H.,Municipal Hakodate Hospital | And 9 more authors.
Journal of Hepato-Biliary-Pancreatic Sciences | Year: 2015

Background Two-stage treatment involving stone removal after drainage is recommended for mild to moderate acute cholangitis associated with choledocholithiasis. However, single-stage treatment has some advantages. We aimed to assess the efficacy and safety of single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis. Methods A multicenter, non-randomized, open-label, exploratory clinical trial was performed in 12 institutions. A total of 50 patients with a naïve papilla and a body temperature ≥37 °C who were diagnosed with mild to moderate cholangitis associated with choledocholithiasis were enrolled between August 2012 and February 2014. Results Of the 50 patients, 15 had mild cholangitis and 35 had moderate cholangitis. The median number of common bile duct stones was 2 (range, 1-8), and the median diameter of the common bile duct stones was 7.5 mm (range, 1-18). The cure rate of acute cholangitis within 4 days after single-stage treatment was 90% (45/50) based on a body temperature <37 °C for ≥24 h. The incidence of complications was 10% (5/50). Conclusion Single-stage endoscopic treatment may be effective and safe for mild to moderate acute cholangitis associated with choledocholithiasis (clinical trial registration number: UMIN000008494). Highlight Eto and colleagues demonstrated high cure rates and low complication rates in the first multicenter prospective study to verify the still controversial efficacy and safety of single-stage endoscopic treatment involving endoscopic retrograde cholangiopancreatography and sphincterotomy for mild to moderate acute cholangitis associated with choledocholithiasis according to the TG07. © 2015 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Kobayashi Y.,Hokkaido University | Komatsu Y.,Hokkaido University | Yuki S.,Hokkaido University | Fukushima H.,Hokkaido University | And 19 more authors.
Future Oncology | Year: 2015

Aim: We planned a randomized, open-label trial to evaluate differences between pre-emptive and reactive skin treatment for panitumumab (Pmab)-associated skin toxicities in Japanese patients with metastatic colorectal cancer. Patients & methods: Patients receiving third-line Pmab-containing regimens were randomized to pre-emptive or reactive treatment. The primary end point was the cumulative incidence of ≥grade 2 skin toxicities during 6 weeks. Retrospectively, a dermatologist reviewed skin toxicities, in a blinded manner. Results: A total of 95 patients were enrolled (pre-emptive: 47, reactive: 48). The primary end point was achieved (21.3 and 62.5% [risk ratio: 0.34; p < 0.001], for pre-emptive and reactive treatment, respectively). A similar trend was observed in central review. Conclusion: Pre-emptive skin treatment could reduce the severity of Pmab-associated skin toxicities in Japanese metastatic colorectal cancer patients. © 2015 Future Medicine Ltd.

Suda G.,Hokkaido University | Yamamoto Y.,Hakodate City Hospital | Nagasaka A.,Sapporo City General Hospital | Furuya K.,Hokkaido Social Insurance Hospital | And 39 more authors.
Hepatology Research | Year: 2015

Aim: Telaprevir-based therapy for chronic hepatitis C patients is effective; however, the high prevalence of dermatological reactions is an outstanding issue. The mechanism and characteristics of such adverse reactions are unclear; moreover, predictive factors remain unknown. Granulysin was recently reported to be upregulated in the blisters of patients with Stevens-Johnson syndrome (SJS). Therefore, we investigated the risk factors for severe telaprevir-induced dermatological reactions as well as the association between serum granulysin levels and the severity of such reactions. Methods: A total of 89 patients who received telaprevir-based therapy and had complete clinical information were analyzed. We analyzed the associations between dermatological reactions and clinical factors. Next, we investigated the time-dependent changes in serum granulysin levels in five and 14 patients with grade 3 and non-grade 3 dermatological reactions, respectively. Results: Of the 89 patients, 57 patients had dermatological reactions, including nine patients with grade 3. Univariate analysis revealed that grade 3 dermatological reactions were significantly associated with male sex. Moreover, serum granulysin levels were significantly associated with the severity of dermatological reactions. Three patients with grade 3 dermatological reaction had severe systemic manifestations including SJS, drug-induced hypersensitivity syndrome, and systemic lymphoid swelling and high-grade fever; all were hospitalized. Importantly, among the three patients, two patients' serum granulysin levels exceeded 8ng/mL at onset and symptoms deteriorated within 6 days. Conclusion: Male patients are at high risk for severe telaprevir-induced dermatological reactions. Moreover, serum granulysin levels are significantly associated with the severity of dermatological reactions and may be a predictive factor in patients treated with telaprevir-based therapy. © 2015 John Wiley & Sons, Ltd.

Kuwatani M.,Hokkaido University | Kawakami H.,Hokkaido University | Hayashi T.,Sapporo Medical University | Eto K.,Tomakomai City Hospital | And 4 more authors.
Endoscopic Ultrasound | Year: 2014

Background and Objective: Antispasmodic drugs (ADs) have been used to reduce examination time or improve the quality of gastrointestinal endoscopy, although the practice is controversial. No evidence about the efficacy of AD for endoscopic ultrasonography/EUS-guided fine-needle aspiration (EUS/EUS-FNA) is available. This study was aimed to evaluate the efficacy of AD in EUS/EUS-FNA. Patients and Methods: A total of 400 patients with pancreaticobiliary, peripancreatic, or peribiliary disease or disorder undergoing EUS/EUS-FNA were prospectively and evenly randomized to undergo EUS/EUS-FNA with AD (w-AD) or without AD (w/o-AD). The primary endpoint was total EUS/EUS-FNA examination time. The secondary endpoints were visual analogue scale (VAS) scores of endoscopists (patient body motion, gastrointestinal peristalsis, and accomplishment of the purpose) and patients (pain, discomfort, and willingness to undergo re-examination), vital sign changes, adverse events, and sedative dose. Results: Two hundred patients in the w-AD group and 197 patients in the w/o-AD group were ultimately analyzed. The total examination time was similar between the groups (2299 ± 937 vs. 2259 ± 1019 s). The difference in total examination time from w/o-AD group to w-AD group was -40 s (95% confidence interval, -234-153 s), which was within the noninferiority margin. No statistical differences were observed in endoscopist and patient VAS scores, changes in vital signs, adverse events, or total sedative dose other than fentanyl between the groups. Conclusion: EUS/EUS-FNA can be effectively and safely performed w/o-AD. Further, randomized controlled trials on EUS/EUS-FNA in various disease entities may be required to confirm the results of this study (UMIN000008047).

Miyashita K.,Abashiri Kosei General Hospital | Kang J.-H.,Center for Gastroenterology | Saga A.,Aiiku Hospital | Takahashi K.,Toshiba General Hospital | And 16 more authors.
Hepatology Research | Year: 2012

Aim: In developed countries including Japan, the transmission route of indigenous hepatitis E virus (HEV) infection is obscure. Accordingly, public health implications of indigenous HEV infection have not been well addressed. The aim of this study was to clarify the route of transmission of a small outbreak of acute hepatitis E and assess the public health implications of indigenous zoonotic HEV transmission. Methods: Three patients with non-A, B and C acute hepatitis, two of whom presented in a critical condition, were assessed for HEV infection using polymerase chain reaction and their route of infection; the genome sequences of the infecting HEV were also analyzed. A phylogenetic tree based on the full, or near full, HEV RNA sequences were constructed by neighbor-joining method. Results: All three patients ingested grilled pork meat and entrails at the same barbecue restaurant in Abashiri, Hokkaido, Japan. When comparing partial to entire, or nearly entire, nucleotide sequences of HEV detected in these patients, they were 99.9-100% identical to each other. These genotype 4 isolates had great resemblance to the genome sequences of the isolates from the mini-outbreak in 2004 in Kitami, a city adjacent to Abashiri. These Kitami/Abashiri strains were segregated into a single cluster on the phylogenetic tree of HEV genotype 4 indigenous to Japan. Conclusion: Indigenous HEV transmission via a zoonotic food-borne route has been demonstrated in Kitami and Abashiri via pork meat and entrails contaminated with virulent HEV strains. Because a similar outbreak can recur in the future, infection sources and distribution routes should be clarified rapidly for public health. © 2012 The Japan Society of Hepatology.

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