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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.


PubMed | Red Cross, Abashiri Kosei General Hospital, Sapporo Higashi Tokushukai Hospital, Tomakomai City Hospital and 8 more.
Type: Clinical Trial | Journal: Journal of hepato-biliary-pancreatic sciences | Year: 2016

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.A multicenter, non-randomized, open-label, exploratory clinical trial was performed in 12 institutions. A total of 50 patients with a nave papilla and a body temperature 37C who were diagnosed with mild to moderate cholangitis associated with choledocholithiasis were enrolled between August 2012 and February 2014.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 7.5mm (range, 1-18). The cure rate of acute cholangitis within 4days after single-stage treatment was 90% (45/50) based on a body temperature <37C for 24h. The incidence of complications was 10% (5/50).Single-stage endoscopic treatment may be effective and safe for mild to moderate acute cholangitis associated with choledocholithiasis (clinical trial registration number: UMIN000008494).


PubMed | Red Cross, Abashiri Kosei General Hospital, Tomakomai City Hospital, Nippon Telegraph and Telephone and 8 more.
Type: Journal Article | Journal: Endoscopy | Year: 2016

Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent. We therefore conducted a multicenter prospective randomized trial to compare catheter performance.We enrolled patients with a BDS diameter 10mm and common bile duct diameter 15mm. Participants were randomly assigned to groups that were treated with basket or balloon catheters between October 2013 and September 2014. The primary endpoint was the rate of complete clearance of the duct; the secondary endpoints were the rate and time to complete clearance in one endoscopic session.We initially enrolled 172 consecutive patients; 14 were excluded after randomization. The complete clearance rates were 92.3% (72/78) in the balloon group and 80.0% (64/80) in the basket group.The difference in the rates between the two groups was 12.3 percentage points, indicating non-inferiority of the balloon method (non-inferiority limit -10%; P<0.001 for non-inferiority). Moreover, the balloon was superior to the basket (P=0.037). The rate of complete clearance in one endoscopic session was 97.4% using the balloon and 97.5% using the basket (P=1.00). The median times to complete clearance in one endoscopic session were 6.0 minutes (1-30) and 7.8 minutes (1-37) in the balloon and basket groups, respectively (P=0.15).For extraction of BDSs10mm, complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter.University Hospital Medical Information Network Trials Registry: UMIN000011887.


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.


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).


PubMed | Hakodate Municipal Hospital, Sapporo Medical University, Tomakomai City Hospital, Abashiri Kosei General Hospital and Hokkaido University
Type: Journal Article | Journal: Endoscopic ultrasound | Year: 2014

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.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.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.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 | Miyashita K.,Aiiku Hospital | Kang J.-H.,Teine Keijinkai Hospital | Saga A.,Aiiku Hospital | And 17 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.


Imai A.,Abashiri Kosei General Hospital | Osada T.,Abashiri Kosei General Hospital | Suzuki T.,Abashiri Kosei General Hospital | Kobayashi T.,Abashiri Kosei General Hospital | And 3 more authors.
Japanese Journal of Cancer and Chemotherapy | Year: 2012

A-63-year-old man was admitted to our hospital because of epigastralgia. On gastrointestinal fiberscopy, a complete obstruction of the pylorus was found, and endoscopic biopsy specimens from this region revealed gastric small cell carcinoma. CT scans showed the primary tumor at the pylorus with many regional lymph node metastases invading the pancreas. We performed gastrojejunostomy, followed by chemotherapy with irinotecan plus cisplatin (CDDP 30 mg/m 2 and CPT-11 60 mg/m2 on day 1 and 15). Three courses of treatment resulted in a marked reduction of both the primary tumor and regional lymph nodes. Subsequently, the patient underwent distal gastrectomy. Micro examination, revealed that the tumor had mostly changed to necrosis and fibrosis, and the pathological TNM grading was pT3 (SS) pN0M0, stage II A. Postoperatively, three courses of the same chemotherapy were performed. However, the patient died 5 months after the second operation, due to meningitis carcinomatosa without metastases of other organs.


PubMed | Asahikawa University, Abashiri Kosei General Hospital and Keio University
Type: Journal Article | Journal: Pediatrics international : official journal of the Japan Pediatric Society | Year: 2016

Over the past few years, several drugs, each with a different mechanism, have been developed for the treatment of pulmonary hypertension (PH) and are now prescribed in the clinical setting. While the optimal doses of these drugs in adults have been determined, the optimal dose in children, however, is unclear. The aim of this study was therefore, to measure blood drug levels and analyze the pharmacokinetics of two such drugs in children.From April 2010 to May 2015, we prospectively enrolled 23 children with PH for treatment with bosentan and/or tadalafil. Twenty children were treated with bosentan and 19 received tadalafil. Sixteen children were given both drugs. Blood samples were collected after 2 weeks of treatment, and blood drug levels measured using high-performance liquid chromatography.For both drugs, the peak plasma concentration was lower and the half-life was shorter than the known values in adults. The blood trough level of bosentan significantly correlated with its dose, but no such correlation was seen for tadalafil. For both drugs, no correlation was observed between age and blood drug levels.Oral dosing with bosentan and tadalafil in children may not achieve therapeutic blood concentration. Thus, the optimal dosing must be established individually while monitoring blood drug level.


PubMed | Abashiri Kosei General Hospital
Type: Case Reports | Journal: Gan to kagaku ryoho. Cancer & chemotherapy | Year: 2012

A-63-year-old man was admitted to our hospital because of epigastralgia. On gastrointestinal fiberscopy, a complete obstruction of the pylorus was found, and endoscopic biopsy specimens from this region revealed gastric small cell carcinoma. CT scans showed the primary tumor at the pylorus with many regional lymph node metastases invading the pancreas. We performed gastrojejunostomy, followed by chemotherapy with irinotecan plus cisplatin (CDDP 30mg/m and CPT-11 60mg/ m on day 1 and 15). Three courses of treatment resulted in a marked reduction of both the primary tumor and regional lymph nodes. Subsequently, the patient underwent distal gastrectomy. Micro examination, revealed that the tumor had mostly changed to necrosis and fibrosis, and the pathological TNM grading was pT3 (SS) pN0M0, stage II A. Postoperatively, three courses of the same chemotherapy were performed. However, the patient died 5 months after the second operation, due to meningitis carcinomatosa without metastases of other organs.

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