Deep learning-based image reconstruction for the multi-arterial phase images: improvement of the image quality to assess the small hypervascular hepatic tumor on gadoxetic acid-enhanced liver MRI.

PURPOSE: To evaluated the impact of a deep learning (DL)-based image reconstruction on multi-arterial-phase magnetic resonance imaging (MA-MRI) for small hypervascular hepatic masses in patients who underwent gadoxetic acid-enhanced liver MRI. METHODS: We retrospectively enrolled 55 adult patients (aged ≥ 18 years) with small hepatic hypervascular mass (≤ 3 cm) between December 2022 and February 2023. All patients underwent MA-MRI, subsequently reconstructed with a DL-based application. Qualitative assessment with Linkert scale including motion artifact (MA), liver edge (LE), hepatic vessel clarity (HVC) and image quality (IQ) was performed. Quantitative image analysis including signal to noise ratio (SNR), contrast to noise ratio (CNR) and noise was performed. RESULTS: On both arterial phases (APs), all qualitative parameters were significantly improved after DL-based image reconstruction. (LE on 1st AP, 1.22 vs 1.61; LE on 2nd AP, 1.21 vs 1.65; HVC on 1st AP, 1.24 vs 1.39; HVC on 2nd AP, 1.24 vs 1.44; IQ on 1st AP, 1.17 vs 1.45; IQ on 2nd AP, 1.17 vs 1.47, all p values < 0.05). The SNR, CNR and noise were significantly improved after DL-based image reconstruction. (SNR on AP1, 279.08 vs 176.14; SNR on AP2, 334.34 vs 199.24; CNR on AP1, 106.09 vs 64.14; CNR on AP2, 129.66 vs 73.73; noise on AP1, 1.51 vs 2.33; noise on AP2, 1.45 vs 2.28, all p values < 0.05). CONCLUSIONS: Gadoxetic acid-enhanced MA-MRI with DL-based image reconstruction improved the qualitative and quantitative parameters. Despite the short acquisition time, high-quality MA-MRI is now achievable.

Survival benefit of concurrent chemoradiotherapy for advanced ampulla of Vater cancer.

BACKGROUND: Currently, there is no standard adjuvant therapy for patients with resected ampulla of Vater (AoV) cancer. AIM: To evaluate the effectiveness of adjuvant concurrent chemoradiotherapy (CCRT) in patients with advanced AoV cancer who underwent curative resection. METHODS: This single-centered, retrospective study included 29 patients with advanced AoV cancer who underwent pancreaticoduodenectomy between 2006 and 2018. The impact of CCRT on advanced AoV cancer was analyzed. RESULTS: The 1-, 3-, and 5-yr recurrence-free survival (RFS) rates for patients with advanced AoV cancer were 82.8%, 48.3%, and 40.8%, respectively, and the overall survival (OS) rates were 89.7%, 62.1%, and 51.7%, respectively. Lymphovascular invasion was found to be a significant risk factor for RFS and OS in patients with advanced AoV cancer in the univariate analysis, whereas T stage and lymph node metastasis were significantly associated with OS in the multivariate analysis. Compared to the patients who did not receive adjuvant CCRT, those who received adjuvant CCRT did not show statistically significant improvements in the RFS and OS, although they had a significantly lower average age and significantly higher platelet-to-lymphocyte ratio. CONCLUSION: Adjuvant CCRT did not improve survival outcomes in patients with advanced AoV cancer. These findings contribute to existing knowledge on the effectiveness of CCRT in this patient population and provide important insights for clinical decision-making.

Clinical impact of ampulla of Vater cancer subtype classification based on immunohistochemical staining.

BACKGROUND: The histological subtype is an important prognostic factor for ampulla of Vater (AoV) cancer. This study proposes a classification system for the histological subtyping of AoV cancer based on immunohistochemical (IHC) staining and its prognostic significance. METHODS: Seventy-five AoV cancers were analyzed for cytokeratin 7 (CK7), CK20, and causal-type homeobox transcription factor 2 (CDX2) expression by IHC staining. We differentiated the subtypes (INT, intestinal; PB, pancreatobiliary; MIX, mixed; NOS, not otherwise specified) into classification I: CK7/CK20, classification II: CK7/CK20 or CDX2, classification III: CK7/CDX2 and examined their associations with clinicopathological factors. RESULTS: Classifications I, II, and III subtypes were INT (7, 10, and 10 cases), PB (43, 37, and 38 cases), MIX (13, 19, and 18 cases), and NOS (12, 9, and 9 cases). Significant differences in disease-free survival among the subtypes were observed in classifications II and III using CDX2; the PB and NOS subtype exhibited shorter survival time compared with INT subtype. In classification III, an association was revealed between advanced T/N stage, poor differentiation, lymphovascular invasion (LVI), the PB and NOS subtypes, and recurrence risk. In classification III, the subtypes differed significantly in T/N stage and LVI. Patients with the PB subtype had advanced T and N stages and a higher incidence of LVI. CONCLUSIONS: Classification using CDX2 revealed subtypes with distinct prognostic significance. Combining CK7 and CDX2 or adding CDX2 to CK7/CK20 is useful for distinguishing subtypes, predicting disease outcomes, and impacting the clinical management of patients with AoV cancer.

Clinicopathological characteristics of extrahepatic biliary neuroendocrine neoplasms in the gallbladder, extrahepatic biliary tract, and ampulla of Vater: A single-center cross-sectional study.

Backgrounds/Aims: In 2019, the grading and staging system for neuroendocrine neoplasms (NENs) was significantly changed. In this study, we report the clinicopathological characteristics and surgical outcomes of patients with extrahepatic biliary NENs who underwent curative resection with or without adjuvant treatment. Methods: We retrospectively reviewed a database of 16 patients who developed NENs, neuroendocrine carcinoma (NEC), and mixed endocrine non-endocrine neoplasms (MiNENs) after curative resection. Among them, eight patients had ampulla of Vater (AoV) tumors, and eight patients had non-AoV tumors. Results: G1 and G2 were more frequently observed in the AoV group than in the non-AoV group (12.5% and 62.5%, respectively). In contrast, NEC and MiNEN were more common in the non-AoV group (50.0%). High Ki-67 index (> 20%) and perineural invasion (PNI) were more frequently observed in the non-AoV group. Advanced age (> 65 years), mitotic count > 20 per 2 mm2, and Ki-67 index > 20% were strongly correlated with patient survival (p = 0.018, 0.009, and 0.044, respectively). Advanced age (> 65 years) and mitotic count > 20 per 2 mm2 were significantly correlated with disease recurrence (p = 0.033 and 0.010, respectively). Conclusions: AoV and non-AoV tumors had significant differences in the histologic grade, Ki67, and PNI. Patients with non-AoV tumors had an increased risk for survival and recurrence than those in the AoV group. For extrahepatic biliary NENs, early detection of tumors, adequate surgery, and aggressive adjuvant treatment for high-risk patients are important to achieve long-term survival and prevent disease recurrence.

Successful resolution of gastric perforation caused by a severe complication of pancreatic walled-off necrosis: A case report.

BACKGROUND: Pancreatic walled-off necrosis (WON) rarely causes critical gastric necrosis and perforation, which may develop when pancreatic WON squashes against the stomach. The Atlanta 2012 guidelines were introduced for acute pancreatitis and its related clinical entities. However, there are few reported cases describing the clinical course and resolution of pancreatic WON. CASE SUMMARY: We report the case of a 45-year-old man who presented to the urgent emergency department with gastric perforation caused by a severe complication of pancreatic WON on computed tomography. The patient underwent an emergency distal pancreatectomy, splenectomy, and gastric wedge resection. Postoperative findings showed re-perforation of the gastric wall at a previously resected margin. Furthermore, endoscopic examination revealed an ulcerative area with a defect in the fundus. After diagnostic endoscopy, endoscopic vacuum-assisted closure was performed, and continuous suction was transferred over all tissues in contact with the sponge surface. The patient recovered without any further complications and was discharged in good condition at postoperative week 8. No recurrence occurred during the 6-mo follow-up period. CONCLUSION: When managing a patient with serious gastric perforation complicated by pancreatic WON, a multidisciplinary treatment approach should be considered.

Clinical significance of C-reactive protein-to-prealbumin ratio in predicting early recurrence in resectable pancreatic cancer.

PURPOSE: Resectable pancreatic ductal adenocarcinoma (PDAC) has a high risk of recurrence after curative resection; despite this, the preoperative risk factors for predicting early recurrence remain unclear. This study therefore aimed to identify preoperative inflammation and nutrition factors associated with early recurrence of resectable PDAC. METHODS: From March 2021 to November 2021, a total of 20 patients who underwent curative resection for PDAC were enrolled in this study. We evaluated the risk factors for early recurrence within 1 year by univariate and multivariate analyses using Cox hazard proportional regression. The cutoff values for predicting recurrence were examined using receiver operating characteristic (ROC) curves. RESULTS: In our univariate and multivariate analyses, C-reactive protein (CRP), CRP-albumin ratio, and CRP-prealbumin ratio, as well as sex and age, were significant independent prognostic factors for early recurrence in PDAC. However, known inflammatory factors (neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios), nutritional factors (albumin, prealbumin, ferritin, vitamin D), and inflammatory-nutritional factors (Glasgow Prognostic Score, modified Glasgow Prognostic Score, albumin-bilirubin) showed no association with early recurrence. In addition, using cutoff values by ROC curve analysis, a high preoperative CRP level of >5 mg/L, as well as high CRP-to-albumin (>5.3) and CRP-to-prealbumin (>1.3) ratios showed no prognostic value. CONCLUSION: Our results showed that inflammatory and perioperative nutritional factors, especially CRP-to-prealbumin ratio, have significant associations with early recurrence after curative resection in resectable PDAC. Therefore, for such patients, a cautious approach is needed when inflammation and poor nutritional status are present.

Postoperative delirium after cholecystectomy in older patients: A retrospective study.

Backgrounds/Aims: Postoperative delirium (POD) is a common complication that increases mortality and morbidity in older patients. This study aimed to evaluate the clinical significance of post-cholecystectomy delirium in older patients. Methods: This retrospective study included 201 patients aged > 75 years who underwent cholecystectomy for acute or chronic cholecystitis between January 2016 and December 2019. Patients were divided into the POD (n = 21) and non-POD (n = 180) groups, and their demographic features and clinical results were compared. Results: The mean patient age was 78.88 years; the female/male ratio was 44.8%/55.2%. Laparoscopic surgery was performed in 93.5% of patients. The univariate analysis showed that lower body mass index (BMI), immobilized admission status, neuropsychiatric disease history, preoperative intervention (percutaneous drainage), high C-reactive protein, hypoalbuminemia, neutrophilia, hypo-/hyperkalemia, and longer operative time were more frequently observed in the POD group. The multivariate analysis showed that lower BMI (odds ratio [OR], 2.796; p = 0.024), neuropsychiatric disease history (OR, 3.019; p = 0.049), hyperkalemia (OR, 5.972; p = 0.007), and longer operative time (OR, 1.011; p = 0.013) were significant risk factors for POD. Conclusions: POD was associated with inflammation degree, general condition, poor nutritional status, electrolyte imbalance, and stressful conditions. Recognizing risk factors requiring multidisciplinary team approaches is important to prevent and treat POD.

Proposal of nomograms to predict clinical outcomes in patients with ampulla of Vater cancer based on the Korea-Japan collaborative study.

BACKGROUND: In this study, we aimed to develop and validate a nomogram to predict overall survival (OS) and recurrence-free survival (RFS) in patients who underwent curative resection of ampulla of Vater (AOV) cancer. This is the first study for nomograms in AOV cancer patients using retrospective data based on an international multicenter study. METHODS: A total of 2007 patients with AOV adenocarcinoma who received operative therapy between 2002 January and 2015 December in Korea and Japan were retrospectively assessed to develop a prediction model. Nomograms for 5-year OS and 3-year RFS were constructed by dividing the patients who received and who did not receive adjuvant therapy after surgery, respectively. Significant risk factors were identified by univariate and multivariate Cox analyses. Performance assessment of the four prediction models was conducted by the Harrell's concordance index (C-index) and calibration curves using bootstrapping. RESULTS: A total of 2007 and 1873 patients were collected for nomogram construction to predict 5-year OS and 3-year RFS. We developed four types of nomograms, including models for 5-year OS and 3-year RFS in patients who did not receive postoperative adjuvant therapy, and 5-year OS and 3-year RFS in patients who received postoperative adjuvant therapy. The C-indices of these nomograms were 0.795 (95% confidence interval [CI]: 0.766-0.823), 0.712 (95% CI: 0.674-0.750), 0.804 (95% CI: 0.7778-0.829), and 0.703 (95% CI: 0.669-0.737), respectively. CONCLUSIONS: This predictive model could help clinicians to choose optimal treatment and precisely predict prognosis in AOV cancer patients.

Revised Clinical Practice Guidelines of the Korean Pancreatobiliary Association for Acute Pancreatitis.

Acute pancreatitis can range from a mild, self-limiting disease requiring no more than supportive care, to severe disease with life-threatening complications. With the goal of providing a recommendation framework for clinicians to manage acute pancreatitis, and to contribute to improvements in national health care, the Korean Pancreatobiliary Association (KPBA) established the Korean guidelines for acute pancreatitis management in 2013. However, many challenging issues exist which often lead to differences in clinical practices. In addition, with newly obtained evidence regarding acute pancreatitis, there have been great changes in recent knowledge and information regarding this disorder. Therefore, the KPBA committee underwent an extensive revision of the guidelines. The revised guidelines were developed using the Delphi method, and the main topics of the guidelines include the following: diagnosis, severity assessment, initial treatment, nutritional support, convalescent treatment, and the treatment of local complications and necrotizing pancreatitis. Specific recommendations are presented, along with the evidence levels and recommendation grades.

HER2 status based on breast cancer guidelines as a useful prognostic marker of T2 gallbladder cancer.

INTRODUCTION: T2 gallbladder cancer (GBC) is the only stage showing a survival benefit after complete surgical resection, but recurrence rates remain high. Although human epidermal growth factor receptor 2 (HER2) has emerged as a therapeutic target, its role in T2 GBC remains unclear. This study investigated the status and prognostic impact of HER2 expression on T2 GBC. MATERIALS AND METHODS: HER2 expression and amplification were detected by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), respectively, in 90 patients with T2 GBC who underwent radical cholecystectomy. We evaluated HER2 status according to the breast and gastric cancer guidelines and analyzed the effect of relevant prognostic factors on survival. RESULTS: HER2 positive status was observed in 11.11% (10/90) and 8.89% (8/90) of cases based on gastric and breast cancer guidelines, respectively. Poor differentiation and a higher level of perineural invasion were independent prognostic factors of disease-free survival (DFS). Old age, male sex, presence of lymph node metastasis, poor differentiation, high levels of perineural invasion, and HER2 positivity based on breast cancer guidelines were identified as independent prognostic factors of overall survival (OS). Patients with HER2-positive T2 GBC according to breast cancer guidelines had worse OS. CONCLUSIONS: HER2 positivity based on breast- but not gastric-cancer guidelines was associated with poorer survival. These results provide a criterion for the evaluation of HER2 and a rationale for therapeutic strategies targeting HER2 in T2 GBC.

Complete resection of large-cell neuroendocrine and hepatocellular carcinoma of the liver: A case report.

BACKGROUND: Combined tumors comprising large-cell neuroendocrine carcinoma and hepatocellular carcinoma have been rarely reported in the literature. CASE SUMMARY: We report a case of a 73-year-old woman with chronic hepatitis B suspected to have a malignant hepatic mass (segment 3; size, 4.5 cm) and lymph node metastasis based on computed tomography and magnetic resonance imaging. Despite being Child-Pugh class A, esophageal varices were present. She underwent left lateral sectionectomy and lymph node dissection. Pathological examination revealed a collision tumor consisting of large-cell neuroendocrine (90%) and hepatocellular (10%) carcinomas. The combined carcinoma had metastasized to one of the three lymph nodes excised. The patient recovered without any postoperative complications and was discharged in good condition on postoperative day 13. Adjuvant chemotherapy was not performed. No recurrence occurred during a follow-up period of 24 mo. CONCLUSION: To improve the therapeutic management of combined tumors in the liver, it is necessary to discuss each clinical experience and consider an appropriate method for the preoperative diagnosis and treatment.

Is left lateral sectionectomy of the liver without operative site drainage safe and effective?

Backgrounds/Aims: Despite its limited benefits, operative site drainage after elective hepatectomy is routinely used. This study aimed to investigate the safety and effectiveness of left lateral sectionectomy without operative site drainage. Methods: This study retrospectively collected data from 31 patients who underwent elective left lateral sectionectomy between January 2017 and June 2020. Based on whether operative site drainage was used, the patients were divided into two groups: drainage and non-drainage of the operative site and a comparative analysis was conducted. Results: A total of 31 patients underwent left lateral sectionectomy during the study period. Of these, 22 patients were diagnosed with hepatocellular carcinoma; three, with intrahepatic cholangiocarcinoma; three, with liver metastasis; and three, with benign liver disease. Ten patients underwent laparoscopy. No significant differences were observed between the open and laparoscopic surgery groups. In the univariate analysis, there were no significant differences in the pre-, intra-, and postoperative clinicopathological factors between the non-drainage and drainage groups. The hospitalization period in the non-drainage group was significantly shorter than in the drainage group (8.44 days vs. 5.87 days, p < 0.05). In the operative site drainage non-use group, there were no cases of intraperitoneal fluid collection requiring additional procedures. Conclusions: Routine use of surgical drainage for left lateral sectionectomy of the liver to prevent intraperitoneal fluid collection is unnecessary.

Diagnostic performance of magnetic resonance image for malignant intraductal papillary mucinous neoplasms: the importance of size of enhancing mural nodule within cyst.

PURPOSE: To investigate the clinical significance of enhancing mural nodules ≥ 5 mm by comparing the diagnostic performance of high-risk stigmata for diagnosing the malignant IPMN between the international consensus guideline (ICG) 2012 and 2017 in pancreatic magnetic resonance image (MRI). MATERIALS AND METHODS: In this retrospective study, we reviewed preoperative pancreatic MRI with surgically confirmed IPMNs between May 2009 and April 2021. High-risk stigmata, defined by ICG 2012 and ICG 2017, associated with malignant IPMN were evaluated using logistic regression analysis. We calculated and compared the sensitivity and specificity of ICG 2012 and ICG 2017 for diagnosing malignant IPMNs. Receiver-operating characteristic (ROC) curves were used to compare ICG 2012 to ICG 2017. RESULTS: A total of 73 patients (43 men and 30 women; mean age, 69 years; standard deviation, 8 years) with 34 malignant IPMNs and 39 benign IPMNs were included. Among high-risk stigmata, enhancing mural nodule ≥ 5 mm, and MPD diameter ≥ 10 mm were the significant predictor of malignant IPMN, in multivariate logistic regression (P < 0.001 for all). For the diagnosis of malignant IPMN, the specificity of ICG 2017 for enhancing mural nodules ≥ 5 mm as the high-risk stigmata was significantly higher than that of ICG 2012 (87.2% vs. 64.1%, P = 0.008). However, there was no significant difference in sensitivity between the two guidelines (94.1% vs. 97.1%, P = 1.0). The comparison of the ROC curves showed that the diagnostic performance of ICG 2017 for malignant IPMNs (AUC, 0.91) significantly improved when compared to that of ICG 2012 (AUC, 0.81) (P = 0.01). CONCLUSION: When applying enhancing mural nodule ≥ 5 mm as a high-risk stigmata, ICG 2017 provided a significantly higher specificity than ICG 2012 without a reduction in sensitivity.

Relationship between high bile juice amylase levels and chronic bacterial infections in patients with gallbladder cancer.

Purpose: Pancreatic enzyme reflux into the biliary tract is associated with chronic inflammation and increased cellular proliferation in the biliary epithelium, leading to biliary carcinoma. We evaluated the relationship between high bile juice amylase levels and biliary microflora in patients with malignant gallbladder lesions. Methods: In this retrospective study, 25 gallbladder specimens were obtained from patients with gallbladder cancer to evaluate amylase levels and perform bacterial culture. The samples were divided into high and low amylase groups and culture-positive and negative groups for analysis. Bile juice amylase 3 times higher than the normal serum amylase level (36-128 IU/L) was considered high. Results: The number of positive cultures was higher in the high amylase group than in the low amylase group, but the difference was insignificant. There were no differences in other clinicopathological factors. Sixteen patients showed positive culture results; Escherichia coli and Klebsiella spp. were the most common gram-negative bacteria, whereas Enterococcus and Streptococcus spp. were the most common gram-positive bacteria. Age and bile juice amylase levels were significantly higher in the culture-positive group than in the culture-negative group. The incidence of bacterial resistance to cephalosporins was 6.25%-35.29%, and this incidence was particularly high for lower-generation cephalosporins. Conclusion: Bacteria in gallbladder were identified more frequently when the amylase level was high. High amylase levels in the gallbladder can be associated with caused chronic bacterial infections with occult pancreaticobiliary reflux, potentially triggering gallbladder cancer.

Clinical impact of serum prealbumin in pancreaticobiliary disease.

Purpose: Although there are many studies on prealbumin in individual diseases such as malignant or inflammatory diseases, there are few comparative studies. This study aimed to compare the clinical differences between prealbumin levels in cholecystitis and pancreaticobiliary malignancies and investigate the clinical impact of low prealbumin levels in pancreaticobiliary malignancies. Methods: From June 2021 to September 2021, 61 patients who had undergone surgery for various pancreaticobiliary diseases were enrolled in this study, and their clinicopathological data were retrospectively analyzed. Results: Many elderly patients with malignant diseases had poor American Society of Anesthesiologists (ASA) scores, significantly lower albumin and prealbumin levels, and higher systemic immune inflammation indices. The low prealbumin group was older; had poorer ASA scores; and had significantly lower body mass index and hemoglobin and albumin levels and higher systemic immune inflammation indices than the normal prealbumin group. In malignant diseases, the low prealbumin group had significantly lower body mass index and hemoglobin levels and a tendency toward more advanced disease (lymph node and distant metastasis). Conclusion: Preoperative low prealbumin levels had an area under the receiver operator characteristic curve of 0.69, suggesting that it may be useful for predicting pancreaticobiliary malignancies. Prealbumin levels were lower in malignant diseases, possibly related to poor nutritional status and systemic immune inflammation. Low prealbumin levels may predict the risk of more advanced disease.

Clinical application of a new hemostatic material using mussel-inspired catecholamine hemostat: A pilot study.

BACKGROUNDS/AIMS: This study aimed to evaluate clinical application of InnoSEAL Plus (a mussel-inspired catecholamine hemostat) as a new hemostatic material for humans. METHODS: Patients treated with topical hemostatic patches after liver resection were enrolled. They were divided into an experimental group (InnoSEAL Plus group) and two control groups (TachoSil® group and Surgicel Fibrillar® group) for efficacy evaluation. RESULTS: A total of 15 patients were enrolled. Each group had five patients. The 3-minute hemostasis success rate was 80.0% (4/5 patients) in the InnoSEAL Plus group, 80.0% (4/5 patients) in the TachoSil® group, and 40.0% (2/5 patients) in the Surgicel Fibrillar® group, showing no significant difference in the success rate among these groups (p > 0.05). All three groups exhibited 100% success rate for 10-minute hemostasis. Both InnoSEAL Plus and TachoSil® groups had one patient developing adverse events, which were treated easily with drug administrations. CONCLUSIONS: InnoSEAL Plus is expected to be functionally not inferior to other conventional hemostatic agents. However, it is necessary to confirm this through multicenter prospective studies in the future.

Multilocular cystic hemangioma of the liver mimicking mucinous cystic neoplasm: a case report.

Hepatic hemangiomas infrequently exhibit atypical imaging features, which may cause diagnostic confusion with hepatic malignancies and lead to unnecessary surgery. We report a rare case of multilocular cystic hemangioma of the liver mimicking a mucinous cystic neoplasm of the liver in a 48-year-old female, focusing on computed tomography and magnetic resonance imaging features and their differential diagnosis.

A multicenter, prospective, randomized clinical trial of marine mussel-inspired adhesive hemostatic materials, InnoSEAL Plus.

PURPOSE: InnoSEAL Plus is an adhesive, coagulant-free hemostatic material that mimics the adhesion mechanism of marine mussels. This study reports on the safety and efficacy of InnoSEAL Plus for patients with hemorrhage after hepatectomy despite first-line hemostasis treatments. METHODS: This is a multicenter, prospective, single-blinded, randomized clinical trial involving 96 hepatectomy patients. TachoSil was used as a comparator group. Three-minute and 10-minute hemostatic success rates were monitored. Rebleeding rates were also observed. Safety was assessed by recording all novel undesirable symptoms. RESULTS: InnoSEAL Plus showed a 3-minute hemostasis rate of 100%, while TachoSil had a rate of 98.0% (48 of 49 patients), demonstrating that the 2 had similar hemostatic efficacies. The difference in efficacy between the test and comparator group was 2.04%, and the lower limit of the one-sided 97.5% confidence interval was -1.92%; as this is greater than the noninferiority limit of -23.9%, the 2 treatments were equivalent. Meanwhile, the 10-minute hemostatic success rate was the same in both groups (100%). No rebleeding occurred in either group. In the safety evaluation, 89 patients experienced adverse events (45 in the test group and 44 in the comparator group). The difference between the 2 groups was not significant. No death occurred after application of the test or comparator group product. CONCLUSION: Given that InnoSEAL Plus is a coagulation factor-free product, the hemostasis results are encouraging, especially considering that TachoSil contains a coagulation factor. InnoSEAL Plus was found to be a safe and effective hemostatic material for control of bleeding in hepatectomy patients.

Vimentin-Positive Circulating Tumor Cells as Diagnostic and Prognostic Biomarkers in Patients with Biliary Tract Cancer.

Biliary tract cancer (BTC) has poor prognosis; thus, early diagnosis is important to decrease mortality. Although vimentin-positive circulating tumor cells (V-CTCs) are a good candidate for diagnostic and prognostic biomarkers, studies on the topic are limited. We aimed to evaluate the diagnostic efficacy of V-CTCs between BTC and benign biliary disease (BBD) and determine the prognostic value of V-CTCs in BTC patients. We recruited 69 participants who had BTCs and BBDs from a single tertiary referral center. We analyzed CTCs and V-CTCs in peripheral blood using the CD-PRIMETM system. Seven patients were excluded due to a technical failure of CTC detection. CTCs were detected in all 62 patients. CTC count > 40/mL blood (55.8% vs. 20%, p = 0.039), V-CTC count > 15/mL blood (57.7% vs. 10%, p = 0.005), and V-CTC/CTC ratio > 40% (48.1% vs. 10%, p = 0.025) were significantly different between BTCs and BBDs. Two or more of these three parameters (61.5% vs. 10%, p = 0.002) increased the accuracy. A combination of CTC markers with CA19-9 and biopsy increased the accuracy (90.4% vs. 10%, p = 0.000). V-CTC > 50/mL blood was a significant factor affecting survival (140 (66.6-213.3) vs. 253 (163.9-342.1) days, p = 0.008). V-CTC could be a potential biomarker for early diagnosis and predicting prognosis in patients with BTC.