Impact of the COVID-19 pandemic on short-term outcomes after pancreaticoduodenectomy for pancreatic cancer: A retrospective study from the Japanese National Clinical Database, 2018-2021.

Aim: The coronavirus disease 2019 (COVID-19) pandemic greatly impacted medical resources such as cancer screening, diagnosis, and treatment given to people for various diseases. We surveyed the impacts of the pandemic on the incidence of complications and mortality following pancreaticoduodenectomy for pancreatic cancer in Japan. Methods: Data on patients who underwent pancreaticoduodenectomy for pancreatic cancer were extracted from the Japanese National Clinical Database (NCD) between 2018 and 2021. The number of the pancreaticoduodenectomy for pancreatic cancer were obtained and then the morbidity and mortality rates were evaluated using a standardized morbidity/mortality ratio (SMR), which is the ratio of the observed number of incidences to the expected number of incidences calculated by the risk calculator previously developed by the NCD. Results: This study included 22 255 cases. The number of pancreaticoduodenectomies exhibited an increasing trend even during the COVID-19 pandemic. The mean observed incidence rates of Grade C pancreatic fistula and Clavien-Dindo grade ≥4 complications, and the 30-day mortality and surgical mortality rates were 0.8%, 1.8%, 0.8% and 0.9%, respectively. The standardized morbidity ratios did not increase during the COVID-19 pandemic. The standardized mortality ratios remained within the range of variations observed before the COVID-19 pandemic. Conclusion: The increasing trend in the number of pancreaticoduodenectomies and favorable short-term outcomes even in the COVID-19 pandemic suggest the medical care for pancreatic cancer in Japan functioned well during the pandemic.

Impact of SARS-CoV-2 infection on short-term postoperative outcomes after gastroenterological cancer surgery using data from a nationwide database in Japan.

Background: Due to the coronavirus disease 2019 (COVID-19) pandemic, cancer screening, diagnosis, and treatment have changed. This study aimed to investigate the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection prior to gastroenterological cancer surgeries on postoperative complications using data from a nationwide database in Japan. Methods: Data on patients who underwent surgery for cancer including esophageal, gastric, colon, rectal, liver, and pancreatic cancer between July 1, 2019, and September 300, 2022, from real-world sources in Japan were analyzed. The association between preoperative SARS-CoV-2 infection and short-term postoperative outcomes was evaluated. A similar analysis stratified according to the interval from SARS-CoV-2 infection to surgery (<4 vs. >4 weeks) was conducted. Results: In total, 60 604 patients were analyzed, and 227 (0.4%) patients were diagnosed with SARS-CoV-2 infection preoperatively. The median interval from SARS-CoV-2 infection to surgery was 25 days. Patients diagnosed with SARS-CoV-2 infection preoperatively had a significantly higher incidence of pneumonia (odds ratio: 2.05; 95% confidence interval: 1.05-3.74; p = 0.036) than those not diagnosed with SARS-CoV-2 infection based on the exact logistic regression analysis adjusted for the characteristics of the patients. A similar finding was observed in patients who had SARS-CoV-2 infection <4 weeks before surgery. Conclusions: Patients with a history of SARS-CoV-2 infection had a significantly higher incidence of pneumonia. This finding can be particularly valuable for countries that have implemented strict regulations in response to the COVID-19 pandemic and have lower SARS-CoV-2 infection-related mortality rates.

Improved survival of pediatric deceased donor liver transplantation recipients after introduction of the pediatric prioritization system: Analysis of data from a Japanese national survey.

BACKGROUND: In Japan, there has never been a national analysis of pediatric deceased donor liver transplantation (pDDLT) based on donor and recipient factors. We constructed a Japanese nationwide database and assessed outcomes of pDDLT focusing on the pediatric prioritization system introduced in 2018. METHODS: We collected data on pDDLTs (<18 years) performed between 1999 and 2021 from the Japan Organ Transplant Network and Japanese Liver Transplantation Society, identified risk factors for graft survival and compared the characteristics and graft survival in pDDLTs conducted before and after the introduction of the pediatric prioritization system. RESULTS: Overall, 112 cases of pDDLT were included, with a 1-year graft survival rate of 86.6%. Four poor prognostic factors were identified: recipient intensive care unit stay, model for end-stage liver disease/pediatric end-stage liver disease score, donor cause of death, and donor total bilirubin. After the introduction of the system, allografts from pediatric donors were more reliably allocated to pediatric recipients and the annual number of pDDLTs increased. The 1-year graft survival rate improved significantly as did pDDLT conditions indicated by the risk factors. CONCLUSIONS: Under the revised allocation system, opportunities for pDDLT increased, resulting in favorable recipient and donor conditions and improved survival.

Impact of the COVID-19 pandemic on the number and short-term outcomes in hepatectomy for hepatocellular carcinoma: Results from the Japanese National Clinical Database, 2018-2021.

AIM: The coronavirus disease 2019 (COVID-19) pandemic has significantly impacted the allocation of medical resources, including cancer screening, diagnosis, and treatment. We aimed to investigate the effects of the pandemic on morbidity and mortality following hepatectomy for hepatocellular carcinoma (HCC). METHODS: We identified patients who underwent hepatectomy for HCC between 2018 and 2021 from the Japanese National Clinical Database (NCD). The number of surgical cases, the use of intensive care units, and the incidence of morbidity were assessed. The standardized morbidity / mortality ratio (SMR) was used to evaluate the rates of morbidity (bile leakage and pneumonia) and mortality in each month, which compares the observed incidence to the expected incidence calculated by the NCD's risk calculator. RESULTS: The study included a total of 10 647 cases. The number of patients undergoing hepatectomy for HCC gradually decreased. The proportion of patients aged 80 years or older increased and that of cases with T1 stage decreased. The proportion of patients who were admitted to the intensive care unit did not change between the pre- and postpandemic period. The mean actual incidence rates of bile leakage, pneumonia, 30-day mortality, and surgical mortality were 9.2%, 2.3%, 1.4%, and 2.1%, respectively. The SMR for the mortalities and morbidities in each month did not increase mostly throughout the COVID-19 pandemic. CONCLUSIONS: The present study showed the decreasing number of resected cases for HCC, while the surgical safety for hepatectomy was enough to be maintained by managing medical resources in Japan.

Phase I study of neoadjuvant S-1 plus cisplatin with concurrent radiation for biliary tract cancer (Tokyo Study Group for Biliary Cancer: TOSBIC02).

Aim: Neoadjuvant chemoradiotherapy may improve survival in patients with advanced cholangiocarcinoma. This Phase I study aimed to determine the recommended dose of neoadjuvant chemoradiotherapy and decide whether to move to a Phase II study. Methods: Patients diagnosed with resectable stage II-IVa cholangiocarcinoma were administered cisplatin (40 [level 0], 50 [level 1 as starting dose], or 60 [level 2] mg/m2), 80 mg/m2 of S-1, and 50.4 Gy of external beam radiation. The recommended dose was defined as a dose one-step lower than the maximum-tolerated dose, which was defined when dose-limiting toxicity was observed in three or more of the six patients. Results: Twelve patients were eligible from November 2012 to May 2016. Ten patients had perihilar cholangiocarcinoma and two patients had distal cholangiocarcinoma. Dose-limiting toxicity was observed in one of the first six patients at level 1 and two of the next six patients at level 2; thus, the maximum-tolerated dose was not determined even at level 2 and the recommended dose was determined as level 2. Four patients had partial response, four patients had stable disease, and two patients had progression of disease because of liver metastases. Finally, nine patients underwent radical surgery and seven cases achieved R0 resection. However, five cases suffered biliary leakage and one suffered intrahospital death due to rupture of the hepatic artery. Conclusion: We determined the recommended dose of neoadjuvant chemoradiotherapy for resectable cholangiocarcinoma. However, we terminated the trial due to a high incidence of morbidity and unexpected mortality.

Japanese national survey on declined liver allografts from brain-dead donors: High decline rate but promising outcomes in allografts with moderate steatosis.

Aim: Liver allografts from brain-dead donors, which were declined and were eventually not transplanted due to accompanying marginal factors, have never been surveyed in Japan. We surveyed the declined allografts and discussed the graft potential focusing on various marginal factors. Methods: We collected data on brain-dead donors between 1999 and 2019 from the Japan Organ Transplant Network. We divided their liver allografts into declined (nontransplanted) and transplanted ones, and then characterized declined ones focusing on their timepoints of decline and accompanying marginal factors. For each marginal factor, we calculated the decline rate from the number of declined and transplanted allografts, and assessed the 1-year graft survival rate from transplanted allografts. Results: A total of 571 liver allografts were divided into 84 (14.7%) declined and 487 (85.3%) transplanted ones. In the declined allografts, a majority was declined after laparotomy (n = 55, 65.5%), most of which had steatosis and/or fibrosis (n = 52). Out of the moderate steatotic (without F ≥ 2 fibrosis) allografts (n = 33), 21 were declined and 12 were transplanted, leading to a 63.6% decline rate. The latter 12 achieved a 92.9% 1-year graft survival rate after transplantation. Comparison of donor background showed no significant difference between the declined and transplanted allografts. Conclusion: Pathological abnormalities of steatosis/fibrosis seem to be the most common donor factor leading to graft decline in Japan. Allografts with moderate steatosis were highly declined; however, transplanted ones achieved promising outcomes. This national survey highlights the potential utility of liver allografts with moderate steatosis.

Development of a risk score model for 1-year graft loss after adult deceased donor liver transplantation in Japan based on a 20-year nationwide cohort.

Aim: Using nationwide data collected over the past 20 years, we aimed to investigate deceased donor liver transplantation (DDLT) outcomes to develop a unique risk model that can be used to establish a standard for organ acceptance in Japan. Methods: Data were collected for 449 recipients aged ≥18 years who underwent DDLT between 1999 and 2019. Least absolute shrinkage and selection operator (LASSO) regression analysis was utilized to develop an original risk score model for 1-year graft loss (termed the Japan Risk Index [JRI]). We developed risk indices according to recipient, donor, and surgery components (termed JRI-R, D, and S, respectively). The JRI was validated via a 5-fold cross-validation. We also compared DDLT outcomes and risk indices among Era1 (-2011), Era2 (-2015), and Era3 (-2019). Results: The 1-year graft survival rate was 89.5% and improved significantly, reaching 84.7%, 87.6%, and 93.9% in Era1, Era2, and Era3, respectively. The JRI was calculated as JRI-R (re-transplantation, Model for End-Stage Liver Disease score, medical condition in intensive care unit) × JRI-D (age, catecholamine index, maximum sodium, maximum total bilirubin) × JRI-S (total ischemic time) × 0.84. The risk model achieved a mean C-statistic value of 0.81 in the validation analysis. The risk index was significantly lower in Era3 than in Era2. Conclusion: Changes in the risk index over time indicated that avoiding risks contributed to the improved outcomes in Era3. The JRI is unique to adult DDLT in Japan and may be useful as a reference for organ acceptance in the future.

Detection of space-time clusters using a topological hierarchy for geospatial data on COVID-19 in Japan.

In this paper, we detected space-time clusters using data on coronavirus disease 2019 (COVID-19) collected daily by each prefecture in Japan. COVID-19 has spread globally since the first confirmed case in China, in December 2019. Several people have to date been infected in Japan since the first confirmed case in January 2020. The outbreak of COVID-19 has had a significant impact on many people's lives. Studies are being conducted to detect regions, called clusters, which pose a significantly higher risk of infection than their surrounding areas, based on a spatial scan statistics of COVID-19 infections. Among these studies, space-time cluster detection has to date been actively performed to gain knowledge regarding infection status. Based on the spatial scan statistic, the cylindrical scan method is a widely used space-time cluster detection method. This method enables concurrent detection of the location and time of a cluster occurrence. However, this method cannot capture spatial changes in a cluster over time. When applying the existing method to a cluster whose shape changes over time, the number of calculations required becomes extremely large, and the analysis may become difficult. In this study, we focused on the hierarchical structure of the data obtained by conducting an echelon analysis and applied the space-time cluster detection method based on this structure to enable the capture of changes in a cluster's shape. Furthermore, we visualized the location and period of a cluster's occurrence and considered the cause of the cluster.

Examination of the characteristics of long-term survivors among patients with gallbladder cancer with liver metastasis who underwent surgical treatment: a retrospective multicenter study (ACRoS1406).

BACKGROUND: Gallbladder cancer (GBC) with liver metastasis is considered unresectable. However, there have been infrequent reports of long-term survival in patients with GBC and liver metastases. Therefore, we examined the characteristics of long-term survivors of gallbladder cancer with liver metastasis. METHODS: A retrospective multicenter study of 462 patients with GBC (mean age, 71 years; female, 51%) was performed. Although patients with pre-operatively diagnosed GBC and liver metastasis were generally excluded from resection, some cases identified during surgery were resected. RESULT: In patients with resected stage III/IV GBC (n = 193), the period 2007-2013 (vs. 2000-2006, hazard ratio 0.63), pre-operative jaundice (hazard ratio 1.70), ≥ 2 liver metastases (vs. no liver metastasis, hazard ratio 2.11), and metastasis to the peritoneum (vs. no peritoneal metastasis, hazard ratio 2.08) were independent prognostic factors for overall survival, whereas one liver metastasis (vs. no liver metastasis) was not. When examining the 5-year overall survival and median survival times by liver metastasis in patients without peritoneal metastasis or pre-operative jaundice, those with one liver metastasis (63.5%, not reached) were comparable to those without liver metastasis (40.4%, 33.0 months), and was better than those with ≥ 2 liver metastases although there was no statistical difference (16.7%, 9.0 months). According to the univariate analysis of resected patients with GBC and liver metastases (n = 26), minor hepatectomy, less blood loss, less surgery time, papillary adenocarcinoma, and T2 were significantly associated with longer survival. Morbidity of Clavien-Dindo classification ≤ 2 and received adjuvant chemotherapy were marginally not significant. Long-term survivors (n = 5) had a high frequency of T2 tumors (4/5), had small liver metastases near the gallbladder during or after surgery, underwent minor hepatectomy without postoperative complications, and received postoperative adjuvant chemotherapy. CONCLUSIONS: Although there is no surgical indication for GBC with liver metastasis diagnosed pre-operatively, minor hepatectomy and postoperative chemotherapy may be an option for selected patients with T2 GBC and liver metastasis identified during or after surgery who do not have other poor prognostic factors.

Gamma-synuclein is a novel prognostic marker that promotes tumor cell migration in biliary tract carcinoma.

Gamma-synuclein (SNCG) promotes invasive behavior and is reportedly a prognostic factor in a range of cancers. However, its role in biliary tract carcinoma (BTC) remains unknown. Consequently, we investigated the clinicopathological significance and function of SNCG in BTC. Using resected BTC specimens from 147 patients with adenocarcinoma (extrahepatic cholangiocarcinoma [ECC, n = 96]; intrahepatic cholangiocarcinoma [ICC, n = 51]), we immunohistochemically evaluated SNCG expression and investigated its correlation with clinicopathological factors and outcomes. Furthermore, cell lines with high SNCG expression were selected from 16 BTC cell lines and these underwent cell proliferation and migration assays by siRNAs. In the results, SNCG expression was present in 22 of 96 (22.9%) ECC patients and in 10 of 51 (19.6%) ICC patients. SNCG expression was significantly correlated with poorly differentiated tumor in both ECC and ICC (p = 0.01 and 0.03, respectively) and with perineural invasion and lymph node metastases in ECC (p = 0.04 and 0.003, respectively). Multivariate analyses revealed that SNCG expression was an independent poor prognostic factor in both OS and RFS in both ECC and ICC. In vitro analyses showed high SNCG expression in three BTC cell lines (NCC-BD1, NCC-BD3, and NCC-CC6-1). Functional analysis revealed that SNCG silencing could suppress cell migration in NCC-BD1 and NCC-CC6-1 and downregulate cell proliferation in NCC-CC6-1 significantly. In conclusion, SNCG may promote tumor cell activity and is potentially a novel prognostic marker in BTC.

Clinical features of Barré-Lièou syndrome and efficacy of trazodone for its treatment: A retrospective single center study.

Barré-Lièou syndrome (BLS) is a manifestation of various autonomic and secondary symptoms including muscle stiffness, tinnitus, dizziness, and pain in various body parts. Although considered to be caused by hyperactivation of the autonomic nervous system due to trauma, there is currently no firmly established etiology or evidence on the treatment and clinical features of BLS. We retrospectively examined the clinical features of BLS and evaluated the efficacy of trazodone (TZD) for its treatment. We conducted a retrospective analysis of the data of 20 consecutive cases with suspected BLS who were treated in our hospital between 2016 and 2019. BLS symptoms were rated on a 10-point scale, and two groups were defined, that is, a mild-BLS group (BLS scores, 1-5) and a severe-BLS group (BLS scores, 6-10). Univariate analysis of patient factors was performed. The BLS score was 6.0 ± 1.7, and the maximum TZD dose was 80 ± 34 mg/day; nine patients (45%) were TZD free, and no TZD side effects were observed, while all patients had a good clinical outcome. There were significant differences between the mild-BLS and severe-BLS groups in the period from injury to diagnosis (p = 0.015), chest/back pain (p < 0.001), constipation (p = 0.001), and maximum TZD dose (p = 0.008). BLS involves posttraumatic autonomic symptoms accompanied by depression and insomnia. The sympathetic hypersensitivity theory could explain its etiology. TZD could effectively and safely treat BLS, and early diagnosis and treatment can contribute toward good clinical outcomes. Enhanced recognition and understanding of this disease are warranted.

Types of intraparenchymal hematoma as a predictor after revascularization in patients with anterior circulation acute ischemic stroke.

BACKGROUND: Intracranial hemorrhage after revascularization for acute ischemic stroke is associated with poor outcomes. Few reports have examined the relationship between parenchymal hematoma after revascularization and clinical outcomes. This retrospective study aimed to investigate the risk factors and clinical outcomes of parenchymal hematoma after revascularization for acute ischemic stroke. METHODS: Ninety-three patients underwent revascularization for anterior circulation acute ischemic stroke. Patient characteristics and clinical outcomes were compared between patients with and without post procedural parenchymal hematoma using the following parameters: age, sex, occlusion location, presence of atrial fibrillation, diffusion-weighted imaging-Alberta stroke program early computed tomography score (DWI-ASPECTS), National Institute of Health Stroke Scale (NIHSS) score, recombinant tissue plasminogen activator, thrombolysis in cerebral infarction > 2b, door-to-puncture time, onset-to-recanalization time, number of passes, and modified Rankin Scale scores. RESULTS: Parenchymal hematomas were not significantly correlated with age, sex, occlusion location, atrial fibrillation, DWI-ASPECTS, NIHSS score, recombinant tissue plasminogen activator, thrombolysis in cerebral infarction > 2b, door-to-puncture time, onset-to-recanalization time, and number of passes, but were significantly correlated with poor clinical outcomes (P = 0.001) and absence of the anterior communicating artery evaluated using pre procedural time-of-flight magnetic resonance angiography (P = 0.03). CONCLUSION: Parenchymal hematoma was a predictor of poor outcomes. In particular, the absence of the anterior communicating artery on pre procedural time-of-flight magnetic resonance angiography is a potential risk factor for parenchymal hematoma after revascularization for anterior circulation acute ischemic stroke.

Peritoneal dissemination of pancreatic cancer caused by endoscopic ultrasound-guided fine needle aspiration: A case report and literature review.

BACKGROUND: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is a biopsy technique widely used to diagnose pancreatic tumors because of its high sensitivity and specificity. Although needle-tract seeding caused by EUS-FNA has been recently reported, dissemination of pancreatic cancer cells is generally considered to be a rare complication that does not affect patient prognosis. However, the frequency of dissemination and needle-tract seeding appears to have been underestimated. We present a case of peritoneal dissemination of pancreatic cancer due to preoperative EUS-FNA. CASE SUMMARY: An 81-year-old man was referred to the Department of Surgery of our hospital in Japan owing to the detection of a pancreatic mass on computed tomography during medical screening. Trans-gastric EUS-FNA revealed that the mass was an adenocarcinoma; hence laparoscopic distal pancreatectomy with lympha-denectomy was performed. No intraoperative peritoneal dissemination and liver metastasis were visually detected, and pelvic lavage cytology was negative for carcinoma cells. The postoperative surgical specimen was negative for carcinoma cells at the dissected margin and the cut end margin; however, pathological findings revealed adenocarcinoma cells on the peritoneal surface proximal to the needle puncture site, and the cells were suspected to be disseminated via EUS- FNA. Hence, the patient received adjuvant therapy with S-1 (tegafur, gimeracil, and oteracil potassium); however, computed tomography performed 5 mo after surgery revealed liver metastasis and cancerous peritonitis. The patient received palliative therapy and died 8 mo after the operation. CONCLUSION: The indications of EUS-FNA should be carefully considered to avoid iatrogenic dissemination, especially for cancers in the pancreatic body or tail.

Usefulness of laparoscopic surgery and preoperative examinations for chronic recurrent small bowel obstruction.

PURPOSE: The aim of this study was to investigate the usefulness of laparoscopic surgery for patients with postoperative abdominal symptoms, including chronic recurrent small-bowel obstruction (SBO), and preoperative examinations of barium follow-through and computed tomography (CT) to predict the postoperative outcomes of laparoscopic surgery. METHODS: Between 2016 and 2018, 49 patients with postoperative symptoms were treated by laparoscopic surgery at our institute. The data from two preoperative examinations were available for 42 patients. The patients were divided into 4 groups: CT-positive (CP, n = 18), barium follow-through-positive (BP, n = 1), both positive (AP [all positive] n = 13), and both negative (AN [all negative], n = 10). RESULTS: Among the 49 patients, 41 received pure laparoscopic surgery, 7 received laparoscopic-assisted surgery with mini-laparotomy, and 1 required conversion. Intra- and postoperative complications occurred in two and seven patients, respectively. Improvement of abdominal symptoms was observed in 40 patients. In terms of the medium-term outcomes, the rate of improvement of symptoms was poorer in the AN group than in the other three groups, but not to a significant degree. CONCLUSION: Laparoscopic surgery was safe and feasible for patients with chronic recurrent abdominal symptoms, including SBO. Furthermore, in patients with negative results on both preoperative examinations, laparoscopic surgery may yield only poor improvement of symptoms.

Characteristics and clinical outcomes in pituitary incidentalomas and non-incidental pituitary tumors treated with endoscopic transsphenoidal surgery.

PURPOSE: In this retrospective study, we investigated the status and validity of endoscopic transsphenoidal surgery (eTSS) for pituitary incidentalomas (PIs) as well as the value of basing the indication for surgery on the PI guidelines. METHODS: Patients who underwent eTSS at Fukuoka University Chikushi Hospital between 2012 and 2018 were divided into the PI group and the non-PI group in accordance with the PI guideline of the Endocrine Society and their clinicopathological characteristics and outcomes were compared and analyzed. RESULTS: A total of 59 patients were enrolled, with 35 patients in the PI group and 24 patients in the non-PI group. The diagnoses in the PI group were of non-functioning pituitary adenoma (NFPA) (n = 12, 34%), gonadotropin-producing pituitary adenoma (n = 8, 23%), Rathke cleft cyst (n = 7, 20%), meningioma (n = 4, 11%), and growth hormone-producing pituitary adenoma (n = 3, 9%); those in the non-PI group were of NFPA (n = 6, 25%), gonadotropin-producing pituitary adenoma (n = 3, 13%), Rathke cleft cyst (n = 3, 13%), growth hormone-producing pituitary adenoma (n = 3, 13%), and prolactin producing pituitary adenoma (n = 3, 13%). Regarding the preoperative factors, 1 patient in the PI group with panhypopituitarism was diagnosed with pituitary apoplexy (pure infarction) of an NFPA. The rates of postoperative anterior pituitary hormonal deficiencies (14% vs 46%, P = .015), residual tumor size (2 ±â€Š5 vs 6 ±â€Š7 mm, P = .008), and reoperation (n = 0, 0% vs n = 5, 21%, P = .005) were significantly different between the PI and non-PI groups. CONCLUSIONS: This study showed that, postoperatively, the incidence of anterior pituitary hormonal deficiencies was lower in the PI than in the non-PI group, although it was comparable between the 2 groups before the operation. The patients in the PI group also had smaller residual tumors and a lower risk of reoperation than those in non-PI group. PIs could have a better postoperative clinical outcome than non-PIs when the indication for eTSS is based on preoperative scrutiny according to the PI guidelines and eTSS is performed by an experienced pituitary surgeon. Hence, more aggressive scrutiny and treatment for PIs might be desirable.

A prospective feasibility study of one-year administration of adjuvant S-1 therapy for resected biliary tract cancer in a multi-institutional trial (Tokyo Study Group for Biliary Cancer: TOSBIC01).

BACKGROUND: Although surgery is the definitive curative treatment for biliary tract cancer (BTC), outcomes after surgery alone have not been satisfactory. Adjuvant therapy with S-1 may improve survival in patients with BTC. This study examined the safety and efficacy of 1 year adjuvant S-1 therapy for BTC in a multi-institutional trial. METHODS: The inclusion criteria were as follows: histologically proven BTC, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, R0 or R1 surgery performed, cancer classified as Stage IB to III. Within 10 weeks post-surgery, a 42-day cycle of treatment with S-1 (80 mg/m2/day orally twice daily on days 1-28 of each cycle) was initiated and continued up to 1 year post surgery. The primary endpoint was adjuvant therapy completion rate. The secondary endpoints were toxicities, disease-free survival (DFS), and overall survival (OS). RESULTS: Forty-six patients met the inclusion criteria of whom 19 had extrahepatic cholangiocarcinoma, 10 had gallbladder carcinoma, 9 had ampullary carcinoma, and 8 had intrahepatic cholangiocarcinoma. Overall, 25 patients completed adjuvant chemotherapy, with a 54.3% completion rate while the completion rate without recurrence during the 1 year administration was 62.5%. Seven patients (15%) experienced adverse events (grade 3/4). The median number of courses administered was 7.5. Thirteen patients needed dose reduction or temporary therapy withdrawal. OS and DFS rates at 1/2 years were 91.2/80.0% and 84.3/77.2%, respectively. Among patients who were administered more than 3 courses of S-1, only one patient discontinued because of adverse events. CONCLUSIONS: One-year administration of adjuvant S-1 therapy for resected BTC was feasible and may be a promising treatment for those with resected BTC. Now, a randomized trial to determine the optimal duration of S-1 is ongoing. TRIAL REGISTRATION: UMIN-CTR, UMIN000009029. Registered 5 October 2012-Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009347.

Safety of direct oral anticoagulant - and antiplatelet therapy in patients with atrial fibrillation treated by carotid artery stenting.

BACKGROUND: The periprocedural administration of dual antiplatelet therapy has been recommended in patients treated by carotid artery stenting. However, some patients with concurrent disease have been prescribed anticoagulants. We compared the post-operative incidence of hemorrhagic and thromboembolic events in two patient groups treated by different regimens of multi-antithrombotic agents. METHODS: As our 31 patients had a history of nonvalvular atrial fibrillation, they had received anticoagulants; they were also treated with aspirin and clopidogrel before carotid artery stenting. The prior anticoagulant therapy was continued in 17 patients and they received vitamin K antagonist plus dual antiplatelet therapy after the procedure (group 1). Other 14 patients underwent direct oral anticoagulant plus aspirin or clopidogrel (group 2). Post-procedural hemorrhagic and thromboembolic events were compared between two groups. RESULTS: Carotid artery stenting was angiographically successful in all patients. Complications were encountered in two group 1 patients. Post-operative image revealed a silent subarachnoid hemorrhage in one. The other presented with superior mesenteric artery occlusion 6 months after the procedure. No hemorrhagic or thromboembolic events occurred in group 2. CONCLUSION: We concluded that the administration of a direct oral anticoagulant plus an antiplatelet agent reduced the risk for periprocedural hemorrhagic and embolic events in patients with concurrent nonvalvular atrial fibrillation who underwent carotid artery stenting.

Predictive factors for liver volume and function recovery after resection using three-dimensional analysis.

BACKGROUND: Clinical and biological factors that predict liver volume recovery rate (LVRR) after liver resection of different resected volume (RV) have not been studied extensively. Moreover, it remains uncertain whether remnant liver volume influences the liver function recovery rate (LFRR). This study examined the predictive factors for LVRR after liver resections of different RV and investigated LFRR by focusing on LVRR improvements after hepatectomy. METHODS: Patients who underwent hepatectomy between January 2013 and August 2015 were reviewed retrospectively. LVRR and LFRR were assessed at postoperative months (POMs) 3, 6, and 12. LVRR was evaluated on the basis of RV (0%-15%, 15%-30%, 30%-45%, and >45%). LFRR was evaluated using total bilirubin, prothrombin time, and platelet count. RESULTS: LVRR was lower with more extensive liver resections. Significant independent predictors of LVRR were type IV collagen 7s domain levels and resection magnitude. Platelet count correlated positively with LVRR at all POMs. CONCLUSIONS: Resected livers regenerated after surgery but did not reach preoperative volumes. Preserving the liver as much as possible during resection can result in greater LFRR after hepatectomy. Therefore, decisions regarding liver resection volume should be made very carefully, particularly in patients with higher type IV collagen 7s domain levels.

Methicillin-resistant Staphylococcus aureus carriers are vulnerable to bloodstream infection after living donor liver transplantation.

BACKGROUND: Bloodstream infection (BSI) is a life-threatening complication after living donor liver transplantation (LDLT). We aimed to explore the incidence and predisposing factors of BSI at our institution. METHODS: We conducted a retrospective cohort analysis on all consecutive adults with BSI within 6 months after LDLT performed between 2005 and 2016. For antimicrobial prophylaxis, ampicillin/sulbactam, cefotaxime, and micafungin were administered. From 2011, methicillin-resistant Staphylococcus aureus (MRSA) carriers were decolonized using mupirocin ointment and chlorhexidine gluconate soap. Risk factors for BSI were identified by uni- and multivariate logistic regression. RESULTS: Of a total of 106 LDLTs, 42 recipients (40%) suffered BSI. The BSI group demonstrated significantly higher in-hospital mortality rates compared with the non-BSI group (24% vs. 7%, P = .01). We identified MRSA carrier (odds ratio [OR], 19.1; P < .001), ABO incompatibility (OR, 2.9; P = .03), and estimated glomerular filtration rate <30 mL/min/1.73m2 (OR, 15.8; P = .02) as independent risk factors for BSI. Decolonization treatment for MRSA carriers did not reduce the incidence of all-cause BSI but reduced the frequency of BSI caused by MRSA. CONCLUSION: To our knowledge, for the first time, MRSA carriers were revealed to be highly vulnerable to BSI after LDLT.