Background/Aims: Biliary tract cancer (BTC) is a rare malignancy with poor prognosis. We investigated genomic determinants of clinical benefit from gemcitabine, cisplatin, and nab-paclitaxel (GAP) versus gemcitabine and cisplatin (GC) in advanced BTC. Methods: Clinical and genomic data using TruSight Oncology 500 were analyzed from patients treated with GAP (N=198) or GC (N=89) as first-line therapy. Results: With a median follow-up of 33.0 months, GAP modestly improved progression-free survival (PFS) (hazard ratio [HR] 0.764; 95% confidence interval [CI] 0.591–0.989) without significant overall survival (OS) difference compared to GC. Genomic profiling revealed frequent alterations in TP53 (35.2%), KRAS (16.4%), SMAD4 (10.5%), and TNFRSF14 (10.5%), involving RTK/RAS (44.3%), TP53 (41.8%), and PI3K (20.2%) pathways. Single-gene mutations did not predict treatment benefit. However, pathway-level analysis identified PI3K pathway activation as significantly associated with inferior PFS (HR 2.148; 95% CI 1.478–3.124) and OS (HR 2.096; 95% CI 1.413–3.109) in patients receiving GAP, an effect not observed with GC. Importantly, GAP conferred clinical benefit only in patients without PI3K pathway activation, while no survival advantage was seen in those with such alterations (Pinteraction=0.023 for PFS, Pinteraction=0.003 for OS). Similar results were obtained in the independent validation cohort treated with GAP (N=103) or GC (N=64) for BTC. Conclusions Genomic profiling using next-generation sequencing identified PI3K pathway activation as key molecular determinant that differentiates patient outcomes between GAP and GC treatments in advanced BTC.

Purpose: We aimed to evaluate the precision of preoperative colonoscopic tattooing and intraoperative colonoscopic tumor localization in determining distal surgical margins for leftsided colorectal cancer surgery. Methods: This retrospective study included 30 patients who underwent laparoscopic colorectal surgery, preoperative colonoscopic tattooing, and intraoperative colonoscopic localization for colorectal cancer at our center between July 2020 and March 2024. Clinical data were collected, and the precision of these methods was assessed by measuring the differences between the target resection margin and the actual pathological resection margin. Results: In four patient cases, the indocyanine green tattoo was not visible in the laparoscopic surgical field. The average stained length of the tattoo was 2.89 cm, with a mean distance of 1.18 cm between the low margin of the tattoo and the cancer. The difference between the target distal resection margin by intraoperative colonoscopic localization and the actual pathological resection margin was 0.88 cm. No complications related to the intraoperative colonoscopy were observed. Conclusion Preoperative tattooing showed limitations, such as spreading and occasional invisibility. Intraoperative colonoscopic localization proved to be an effective method for achieving more precise distal surgical margins in left-sided colorectal cancer surgery.

Background and Objectives: Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR. Methods: All procedures were guided by fluoroscopy and transthoracic echocardiography.The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment. Results: A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period. Conclusions The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.

Purpose: We aimed to evaluate the precision of preoperative colonoscopic tattooing and intraoperative colonoscopic tumor localization in determining distal surgical margins for leftsided colorectal cancer surgery. Methods: This retrospective study included 30 patients who underwent laparoscopic colorectal surgery, preoperative colonoscopic tattooing, and intraoperative colonoscopic localization for colorectal cancer at our center between July 2020 and March 2024. Clinical data were collected, and the precision of these methods was assessed by measuring the differences between the target resection margin and the actual pathological resection margin. Results: In four patient cases, the indocyanine green tattoo was not visible in the laparoscopic surgical field. The average stained length of the tattoo was 2.89 cm, with a mean distance of 1.18 cm between the low margin of the tattoo and the cancer. The difference between the target distal resection margin by intraoperative colonoscopic localization and the actual pathological resection margin was 0.88 cm. No complications related to the intraoperative colonoscopy were observed. Conclusion Preoperative tattooing showed limitations, such as spreading and occasional invisibility. Intraoperative colonoscopic localization proved to be an effective method for achieving more precise distal surgical margins in left-sided colorectal cancer surgery.

Background and Objectives: Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR. Methods: All procedures were guided by fluoroscopy and transthoracic echocardiography.The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment. Results: A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period. Conclusions The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.

Background and Objectives: Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR. Methods: All procedures were guided by fluoroscopy and transthoracic echocardiography.The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment. Results: A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period. Conclusions The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.

Purpose: We aimed to evaluate the precision of preoperative colonoscopic tattooing and intraoperative colonoscopic tumor localization in determining distal surgical margins for leftsided colorectal cancer surgery. Methods: This retrospective study included 30 patients who underwent laparoscopic colorectal surgery, preoperative colonoscopic tattooing, and intraoperative colonoscopic localization for colorectal cancer at our center between July 2020 and March 2024. Clinical data were collected, and the precision of these methods was assessed by measuring the differences between the target resection margin and the actual pathological resection margin. Results: In four patient cases, the indocyanine green tattoo was not visible in the laparoscopic surgical field. The average stained length of the tattoo was 2.89 cm, with a mean distance of 1.18 cm between the low margin of the tattoo and the cancer. The difference between the target distal resection margin by intraoperative colonoscopic localization and the actual pathological resection margin was 0.88 cm. No complications related to the intraoperative colonoscopy were observed. Conclusion Preoperative tattooing showed limitations, such as spreading and occasional invisibility. Intraoperative colonoscopic localization proved to be an effective method for achieving more precise distal surgical margins in left-sided colorectal cancer surgery.

Background and Objectives: Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR. Methods: All procedures were guided by fluoroscopy and transthoracic echocardiography.The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment. Results: A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period. Conclusions The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.

Purpose: Huge (≥10 cm) hepatocellular carcinoma (HCC) poses significant treatment and prognosis challenges. This study aimed to determine whether preoperative transarterial chemoembolization (TACE) for huge HCC is necessary. Methods: This single-center, retrospective cohort study evaluated 435 patients with huge HCC who underwent upfront hepatectomy or hepatectomy after preoperative TACE from January 2009 to December 2018. TACE’s impact on survival and prognostic factors, including microvascular invasion (MVI) and satellite nodules (SNs), was analyzed. Results: The preoperative TACE group (n = 33) had a lower incidence of MVI (P = 0.009) and higher postoperative morbidity (P = 0.001), particularly pleural effusion (P = 0.004) and Clavien-Dindo class III–IV complications (P = 0.033), compared with the upfront hepatectomy group (n = 402). Short-term mortality (P = 0.828) and recurrence within 6 months (P = 0.654) were comparable between groups. The 1-, 3-, and 5-year survival curves showed no significant between-group differences in recurrence-free survival (RFS) (P = 0.172) and overall survival (OS) (P = 0.450). Local regional therapy for intrahepatic recurrences and surgical resection for extrahepatic recurrences were associated with better OS. MVI, SN, and hepatic vein tumor thrombosis were identified as significant risk factors for poorer RFS and OS. In patients without SN, preoperative TACE improved RFS (P = 0.039) but not OS. Conclusion Preoperative TACE for huge HCC was associated with reduced MVI but did not improve RFS and OS. Survival outcomes were more significantly influenced by SN, suggesting that upfront hepatectomy without TACE should be prioritized.

Background: It is well known that a large number of patients with diabetes also have dyslipidemia, which significantly increases the risk of cardiovascular disease (CVD). This study aimed to evaluate the efficacy and safety of combination drugs consisting of metformin and atorvastatin, widely used as therapeutic agents for diabetes and dyslipidemia. Methods: This randomized, double-blind, placebo-controlled, parallel-group and phase III multicenter study included adults with glycosylated hemoglobin (HbA1c) levels >7.0% and <10.0%, low-density lipoprotein cholesterol (LDL-C) >100 and <250 mg/dL. One hundred eighty-five eligible subjects were randomized to the combination group (metformin+atorvastatin), metformin group (metformin+atorvastatin placebo), and atorvastatin group (atorvastatin+metformin placebo). The primary efficacy endpoints were the percent changes in HbA1c and LDL-C levels from baseline at the end of the treatment. Results: After 16 weeks of treatment compared to baseline, HbA1c showed a significant difference of 0.94% compared to the atorvastatin group in the combination group (0.35% vs. −0.58%, respectively; P<0.0001), whereas the proportion of patients with increased HbA1c was also 62% and 15%, respectively, showing a significant difference (P<0.001). The combination group also showed a significant decrease in LDL-C levels compared to the metformin group (−55.20% vs. −7.69%, P<0.001) without previously unknown adverse drug events. Conclusion The addition of atorvastatin to metformin improved HbA1c and LDL-C levels to a significant extent compared to metformin or atorvastatin alone in diabetes and dyslipidemia patients. This study also suggested metformin’s preventive effect on the glucose-elevating potential of atorvastatin in patients with type 2 diabetes mellitus and dyslipidemia, insufficiently controlled with exercise and diet. Metformin and atorvastatin combination might be an effective treatment in reducing the CVD risk in patients with both diabetes and dyslipidemia because of its lowering effect on LDL-C and glucose.