1.Efficacy and Safety of a Novel Tapered-Tip Sheath System for Biliary-Lesion Tissue Sampling: A Randomized Controlled Trial
Hirokazu OKADA ; Norimitsu UZA ; Tomoaki MATSUMORI ; Hajime YAMAZAKI ; Muneji YASUDA ; Takeshi KUWADA ; Yoshihiro NISHIKAWA ; Takahisa MARUNO ; Masahiro SHIOKAWA ; Atsushi TAKAI ; Ken TAKAHASHI ; Akihisa FUKUDA ; Etsuro HATANO ; Sachiko MINAMIGUCHI ; Hiroshi SENO
Gut and Liver 2025;19(1):136-144
Background/Aims:
Pathological evaluation is crucial for diagnosing biliary lesions and determining appropriate treatment strategies. However, tissue sampling via the transpapillary route can be difficult. In this study, we aimed to assess the efficacy and safety of a novel tapered-tip sheath system for tissue sampling from biliary strictures.
Methods:
This single-center, randomized, parallel-group clinical trial included patients aged 20 to 85 years admitted to Kyoto University Hospital for biliary strictures. The patients were randomly assigned (1:1) to a new or conventional method group. The primary outcome was technical success of biopsy at the target bile duct using the assigned method, as determined in accordance with the intention-to-treat principle. Adverse events were assessed in all eligible patients.
Results:
Fifty-six patients were assessed for eligibility between September 2020 and March 2023; 50 patients were enrolled. The patients were randomly divided into the new (n=25) method group and the conventional (n=25) method group. Technical success was achieved in 96.0% (24/25) and 48.0% (12/25) of patients in the new and conventional method groups, respectively (risk ratio, 2.00; 95% confidence interval [CI], 1.32 to 3.03; risk difference, 48.0%; 95% CI, 27.0% to 69.0%; p<0.001). Adverse events occurred in 4.0% (1/25) and 36.0% (9/25) of patients in the new and conventional method groups, respectively (risk ratio, 0.11; 95% CI, 0.02 to 0.81; risk difference, –32.0%; 95% CI, –52.3% to –11.7%; p=0.005).
Conclusions
The novel tapered-tip sheath system is a promising option for precisely and safely delivering biopsy forceps to target sites, thereby facilitating the diagnosis of biliary strictures.
2.Efficacy and Safety of a Novel Tapered-Tip Sheath System for Biliary-Lesion Tissue Sampling: A Randomized Controlled Trial
Hirokazu OKADA ; Norimitsu UZA ; Tomoaki MATSUMORI ; Hajime YAMAZAKI ; Muneji YASUDA ; Takeshi KUWADA ; Yoshihiro NISHIKAWA ; Takahisa MARUNO ; Masahiro SHIOKAWA ; Atsushi TAKAI ; Ken TAKAHASHI ; Akihisa FUKUDA ; Etsuro HATANO ; Sachiko MINAMIGUCHI ; Hiroshi SENO
Gut and Liver 2025;19(1):136-144
Background/Aims:
Pathological evaluation is crucial for diagnosing biliary lesions and determining appropriate treatment strategies. However, tissue sampling via the transpapillary route can be difficult. In this study, we aimed to assess the efficacy and safety of a novel tapered-tip sheath system for tissue sampling from biliary strictures.
Methods:
This single-center, randomized, parallel-group clinical trial included patients aged 20 to 85 years admitted to Kyoto University Hospital for biliary strictures. The patients were randomly assigned (1:1) to a new or conventional method group. The primary outcome was technical success of biopsy at the target bile duct using the assigned method, as determined in accordance with the intention-to-treat principle. Adverse events were assessed in all eligible patients.
Results:
Fifty-six patients were assessed for eligibility between September 2020 and March 2023; 50 patients were enrolled. The patients were randomly divided into the new (n=25) method group and the conventional (n=25) method group. Technical success was achieved in 96.0% (24/25) and 48.0% (12/25) of patients in the new and conventional method groups, respectively (risk ratio, 2.00; 95% confidence interval [CI], 1.32 to 3.03; risk difference, 48.0%; 95% CI, 27.0% to 69.0%; p<0.001). Adverse events occurred in 4.0% (1/25) and 36.0% (9/25) of patients in the new and conventional method groups, respectively (risk ratio, 0.11; 95% CI, 0.02 to 0.81; risk difference, –32.0%; 95% CI, –52.3% to –11.7%; p=0.005).
Conclusions
The novel tapered-tip sheath system is a promising option for precisely and safely delivering biopsy forceps to target sites, thereby facilitating the diagnosis of biliary strictures.
3.Efficacy and Safety of a Novel Tapered-Tip Sheath System for Biliary-Lesion Tissue Sampling: A Randomized Controlled Trial
Hirokazu OKADA ; Norimitsu UZA ; Tomoaki MATSUMORI ; Hajime YAMAZAKI ; Muneji YASUDA ; Takeshi KUWADA ; Yoshihiro NISHIKAWA ; Takahisa MARUNO ; Masahiro SHIOKAWA ; Atsushi TAKAI ; Ken TAKAHASHI ; Akihisa FUKUDA ; Etsuro HATANO ; Sachiko MINAMIGUCHI ; Hiroshi SENO
Gut and Liver 2025;19(1):136-144
Background/Aims:
Pathological evaluation is crucial for diagnosing biliary lesions and determining appropriate treatment strategies. However, tissue sampling via the transpapillary route can be difficult. In this study, we aimed to assess the efficacy and safety of a novel tapered-tip sheath system for tissue sampling from biliary strictures.
Methods:
This single-center, randomized, parallel-group clinical trial included patients aged 20 to 85 years admitted to Kyoto University Hospital for biliary strictures. The patients were randomly assigned (1:1) to a new or conventional method group. The primary outcome was technical success of biopsy at the target bile duct using the assigned method, as determined in accordance with the intention-to-treat principle. Adverse events were assessed in all eligible patients.
Results:
Fifty-six patients were assessed for eligibility between September 2020 and March 2023; 50 patients were enrolled. The patients were randomly divided into the new (n=25) method group and the conventional (n=25) method group. Technical success was achieved in 96.0% (24/25) and 48.0% (12/25) of patients in the new and conventional method groups, respectively (risk ratio, 2.00; 95% confidence interval [CI], 1.32 to 3.03; risk difference, 48.0%; 95% CI, 27.0% to 69.0%; p<0.001). Adverse events occurred in 4.0% (1/25) and 36.0% (9/25) of patients in the new and conventional method groups, respectively (risk ratio, 0.11; 95% CI, 0.02 to 0.81; risk difference, –32.0%; 95% CI, –52.3% to –11.7%; p=0.005).
Conclusions
The novel tapered-tip sheath system is a promising option for precisely and safely delivering biopsy forceps to target sites, thereby facilitating the diagnosis of biliary strictures.
4.Efficacy and Safety of a Novel Tapered-Tip Sheath System for Biliary-Lesion Tissue Sampling: A Randomized Controlled Trial
Hirokazu OKADA ; Norimitsu UZA ; Tomoaki MATSUMORI ; Hajime YAMAZAKI ; Muneji YASUDA ; Takeshi KUWADA ; Yoshihiro NISHIKAWA ; Takahisa MARUNO ; Masahiro SHIOKAWA ; Atsushi TAKAI ; Ken TAKAHASHI ; Akihisa FUKUDA ; Etsuro HATANO ; Sachiko MINAMIGUCHI ; Hiroshi SENO
Gut and Liver 2025;19(1):136-144
Background/Aims:
Pathological evaluation is crucial for diagnosing biliary lesions and determining appropriate treatment strategies. However, tissue sampling via the transpapillary route can be difficult. In this study, we aimed to assess the efficacy and safety of a novel tapered-tip sheath system for tissue sampling from biliary strictures.
Methods:
This single-center, randomized, parallel-group clinical trial included patients aged 20 to 85 years admitted to Kyoto University Hospital for biliary strictures. The patients were randomly assigned (1:1) to a new or conventional method group. The primary outcome was technical success of biopsy at the target bile duct using the assigned method, as determined in accordance with the intention-to-treat principle. Adverse events were assessed in all eligible patients.
Results:
Fifty-six patients were assessed for eligibility between September 2020 and March 2023; 50 patients were enrolled. The patients were randomly divided into the new (n=25) method group and the conventional (n=25) method group. Technical success was achieved in 96.0% (24/25) and 48.0% (12/25) of patients in the new and conventional method groups, respectively (risk ratio, 2.00; 95% confidence interval [CI], 1.32 to 3.03; risk difference, 48.0%; 95% CI, 27.0% to 69.0%; p<0.001). Adverse events occurred in 4.0% (1/25) and 36.0% (9/25) of patients in the new and conventional method groups, respectively (risk ratio, 0.11; 95% CI, 0.02 to 0.81; risk difference, –32.0%; 95% CI, –52.3% to –11.7%; p=0.005).
Conclusions
The novel tapered-tip sheath system is a promising option for precisely and safely delivering biopsy forceps to target sites, thereby facilitating the diagnosis of biliary strictures.
5.Chronic Dissecting Abdominal Aortic Aneurysm Coexisting with Horseshoe Kidney Requiring Supra-Renal Clamp and Reattachment of Accessory Renal Arteries
Atsunori KONO ; Atsushi OMURA ; Shunya CHOMEI ; Mari HAMAGUCHI ; Kazunori SAKAGUCHI ; Hidekazu NAKAI ; Katsuhiro YAMANAKA ; Takeshi INOUE ; Kenji OKADA
Japanese Journal of Cardiovascular Surgery 2024;53(1):33-37
A 60-year-old man underwent open surgery for chronic dissecting abdominal aorta accompanied with a horseshoe kidney. Through open laparotomy, the abdominal aortic aneurysm was exposed without revision of the horseshoe kidney. Cold ringer solution was infused to accessory renal arteries for renal protection. After supra-renal clamping, proximal anastomosis was then performed at the level just below the renal arteries. Abdominal cross clamp time at the level of the supra-renal arteries was 23 min. Median and right accessory arteries were reattached with an ischemic time of 73 and 103 min, respectively. Although serum creatine was elevated a preoperative level of 1.17 mg/dl to 3.63 mg/dl at postoperative day 2, that was gradually decreased to nearly preoperative level of 1.25 mg/dl at discharge. Postoperative enhanced CT demonstrated patency of the reattached accessory arteries. The patient was discharged without major complication on postoperative day 21. One year postoperatively, his follow-up course was uneventful without deterioration of renal function.
6.A Case of Unstable Angina Pectoris With Asymptomatic Internal Carotid Artery and Middle Cerebral Artery Occlusion With Impaired Cerebral Perfusion Reserve Treated With Simultaneous Superficial Temporal Artery-Middle Cerebral Artery Anastomosis and Coronary Artery Bypass Grafting
Kai TAKAYANAGI ; Takeshi OKADA ; Otone ENDO ; Kentaro FUJII ; Tomotaka ISHIZAKI ; Taku HIRAMATSU ; Takenori YAMAZAKI ; Hajime ARIMA
Journal of the Japanese Association of Rural Medicine 2021;70(1):69-75
A 68-year-old woman had unstable angina pectoris with asymptomatic right internal carotid artery and right middle cerebral artery occlusion with impaired cerebral perfusion reserve. The cardiology, cardiovascular surgery, anesthesiology, and neurosurgery departments discussed the treatment plan. We simultaneously performed superficial temporal artery-middle cerebral artery anastomosis and coronary artery bypass grafting to reduce the likelihood of perioperative ischemic stroke. Fortunately, neither cerebral ischemia nor myocardial ischemia occurred. Simultaneous superficial temporal artery-middle cerebral artery anastomosis and coronary artery bypass grafting can be a therapeutic option for patients with unstable angina and impaired cerebral perfusion reserve. However, the risk of bleeding associated with anticoagulation during coronary artery bypass grafting cannot be ignored.
7.A Case of Cyst Formation 20 Years After Gamma Knife Radiosurgery for Cerebral Arteriovenous Malformation
Hayato YOKOYAMA ; Takeshi OKADA ; Otone ENDO ; Kentaro FUJII ; Kai TAKAYANAGI ; Taku HIRAMATSU
Journal of the Japanese Association of Rural Medicine 2020;69(1):79-85
A 52-year-old woman who had two episodes of cerebral hemorrhage due to cerebral arteriovenous malformation (AVM) had been treated with gamma knife radiosurgery twice. Complete obliteration of the AVM was confirmed after treatment and she was making steady progress. Twenty years after gamma knife radiosurgery, computed tomography showed cyst formation. The cyst grew larger with ensuing neurological signs and symptoms, so we performed surgery. Thereafter, it was possible to make a pathological assessment. Delayed cyst formation after gamma knife radiosurgery for AVM is known to be one of the late adverse effects of radiation but little is known beyond 10 years postoperatively. We report here on a case of cyst formation 20 years after gamma knife radiosurgery for AVM.
8.Chronic obstructive pulmonary disease severity in middle-aged and older men with steoporosis associates with decreased bone formation
Manabu TSUKAMOTO ; Toshiharu MORI ; Eiichiro NAKAMURA ; Yasuaki OKADA ; Hokuto FUKUDA ; Yoshiaki YAMANAKA ; Ken SABANAI ; Ke-Yong WANG ; Takeshi HANAGIRI ; Satoshi KUBOI ; Kazuhiro YATERA ; Akinori SAKAI
Osteoporosis and Sarcopenia 2020;6(4):179-187
Objectives:
Chronic obstructive pulmonary disease (COPD) is a risk factor for osteoporosis. Nevertheless, much remains unclear regarding the bone metabolism dynamics associated with COPD. The present study focuses on the associations between the COPD severity and serum bone metabolism biomarkers.
Methods:
We enrolled 40 patients who visited the orthopedics departments at our institutions and underwent dual-energy X-ray absorptiometry between September 2015 and December 2017. Only male osteoporosis patients over 45 years of age were included, and 5 patients were excluded due to disease or use of internal medicines affecting bone metabolism. All subjects underwent lung function testing, spine radiography, and blood tests. We measured percent forced expiratory volume in 1 second (%FEV1), which reflects COPD severity, and we examined the relationships between %FEV1and serum levels of bone metabolism biomarkers.
Results:
All subjects were diagnosed with osteoporosis based on T-scores. %FEV1 correlated with body weight, body mass index (BMI), and Z-score/T-scores. %FEV1 moderately correlated with serum levels of alkaline phosphatase (ALP), procollagen type 1 N-terminal propeptide (P1NP), and tartrate-resistant acid phosphatase 5b in the partial correlation analysis adjusted for BMI or T-score in the lumbar vertebrae. We performed a hierarchical multiple regression analysis to identify that serum ALP and P1NP were the independent explanatory variables to %FEV1 independent of other factors.
Conclusions
The data suggest that the COPD severity in middle-aged and older men with osteoporosis associates with decreased bone formation. COPD patients may exhibit bone metabolism dynamics characterized by low bone turnover with osteogenesis dysfunction as COPD becomes severe.
9.Chronic obstructive pulmonary disease severity in middle-aged and older men with steoporosis associates with decreased bone formation
Manabu TSUKAMOTO ; Toshiharu MORI ; Eiichiro NAKAMURA ; Yasuaki OKADA ; Hokuto FUKUDA ; Yoshiaki YAMANAKA ; Ken SABANAI ; Ke-Yong WANG ; Takeshi HANAGIRI ; Satoshi KUBOI ; Kazuhiro YATERA ; Akinori SAKAI
Osteoporosis and Sarcopenia 2020;6(4):179-187
Objectives:
Chronic obstructive pulmonary disease (COPD) is a risk factor for osteoporosis. Nevertheless, much remains unclear regarding the bone metabolism dynamics associated with COPD. The present study focuses on the associations between the COPD severity and serum bone metabolism biomarkers.
Methods:
We enrolled 40 patients who visited the orthopedics departments at our institutions and underwent dual-energy X-ray absorptiometry between September 2015 and December 2017. Only male osteoporosis patients over 45 years of age were included, and 5 patients were excluded due to disease or use of internal medicines affecting bone metabolism. All subjects underwent lung function testing, spine radiography, and blood tests. We measured percent forced expiratory volume in 1 second (%FEV1), which reflects COPD severity, and we examined the relationships between %FEV1and serum levels of bone metabolism biomarkers.
Results:
All subjects were diagnosed with osteoporosis based on T-scores. %FEV1 correlated with body weight, body mass index (BMI), and Z-score/T-scores. %FEV1 moderately correlated with serum levels of alkaline phosphatase (ALP), procollagen type 1 N-terminal propeptide (P1NP), and tartrate-resistant acid phosphatase 5b in the partial correlation analysis adjusted for BMI or T-score in the lumbar vertebrae. We performed a hierarchical multiple regression analysis to identify that serum ALP and P1NP were the independent explanatory variables to %FEV1 independent of other factors.
Conclusions
The data suggest that the COPD severity in middle-aged and older men with osteoporosis associates with decreased bone formation. COPD patients may exhibit bone metabolism dynamics characterized by low bone turnover with osteogenesis dysfunction as COPD becomes severe.
10.Utility of Endoscopic Ultrasound-Guided Fine Needle Aspiration in the Diagnosis of Local Recurrence of Pancreaticobiliary Cancer after Surgical Resection
Kazuyuki MATSUMOTO ; Hironari KATO ; Shigeru HORIGUCHI ; Takeshi TOMODA ; Akihiro MATSUMI ; Yuki ISHIHARA ; Yosuke SARAGAI ; Saimon TAKADA ; Shinichiro MURO ; Daisuke UCHIDA ; Hiroyuki OKADA
Gut and Liver 2020;14(5):652-658
Background/Aims:
Endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA; EUS-FNA) allows for diagnostic tissue specimens from various regions to be analyzed. How-ever, diagnosing recurrent pancreaticobiliary cancer after surgery is sometimes difficult. We evaluated the efficacy of EUS-FNA in the diagnosis of local recurrence of pancreatico-biliary cancer and analyzed the factors associated with falsenegative results.
Methods:
Fifty-one consecutive patients who underwent EUS-FNA due to suspected recurrence of pancreaticobiliary cancer after surgery in an academic cen-ter were retrospectively analyzed. The criteria for EUS-FNA were a resected margin or remnant pancreas mass, round swollen lymph node (≥10 mm in diameter), and soft-tissue enhancement around a major artery. Patients with suspected liver metastasis or malignant ascites were excluded.
Results:
Thirty-nine of the 51 patients had pancreatic cancer; the remaining 12 had biliary cancer. The target sites for EUS-FNA were the soft tissue around a major artery (n=22, 43%), the resected margin or remnant pancreas (n=12, 24%), and the lymph nodes (n=17, 33%). The median size of the suspected recurrent lesions was 15 mm (range, 8 to 40 mm). The over-all sensitivity, specificity and accuracy of EUS-FNA for the diagnosis of recurrence was 84% (32/38), 100% (13/13), and 88% (45/51), respectively. FNA of the soft tissue around major arteries (odds ratio, 8.23; 95% confidence interval, 1.2 to 166.7; p=0.033) was significantly associated with a falsenegative diagnosis in the multivariate analysis.
Conclusions
EUS-FNA is useful for diagnosing recurrent cancer, even after pancreaticobiliary surgery. The diagnoses of recurrence at soft-tissue sites should be interpreted with caution.


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