Study design and rationale of "Synergistic Effect of Combination Therapy with Cilostazol and ProbUcol on Plaque Stabilization and Lesion REgression (SECURE)" study: a double-blind randomised controlled multicenter clinical trial

<p>Abstract</p> <p>Background</p> <p>Probucol, a cholesterol-lowering agent that paradoxically also lowers high-density lipoprotein cholesterol has been shown to prevent progression of atherosclerosis. The antiplatelet agent cilostazol, which has diverse antiatherogenic properties, has also been shown to reduce restenosis in previous clinical trials. Recent experimental studies have suggested potential synergy between probucol and cilostazol in preventing atherosclerosis, possibly by suppressing inflammatory reactions and promoting cholesterol efflux.</p> <p>Methods/design</p> <p>The Synergistic Effect of combination therapy with Cilostazol and probUcol on plaque stabilization and lesion REgression (SECURE) study is designed as a double-blind, randomised, controlled, multicenter clinical trial to investigate the effect of cilostazol and probucol combination therapy on plaque volume and composition in comparison with cilostazol monotherapy using intravascular ultrasound and Virtual Histology. The primary end point is the change in the plaque volume of index intermediate lesions between baseline and 9-month follow-up. Secondary endpoints include change in plaque composition, neointimal growth after implantation of stents at percutaneous coronary intervention target lesions, and serum levels of lipid components and biomarkers related to atherosclerosis and inflammation. A total of 118 patients will be included in the study.</p> <p>Discussion</p> <p>The SECURE study will deliver important information on the effects of combination therapy on lipid composition and biomarkers related to atherosclerosis, thereby providing insight into the mechanisms underlying the prevention of atherosclerosis progression by cilostazol and probucol.</p> <p>Trial registration number</p> <p>ClinicalTrials (NCT): <a href="http://www.clinicaltrials.gov/ct2/show/NCT01031667">NCT01031667</a></p

Trans-Umbilical Lymphadenectomy Using an Articulating Bipolar Vessel-Sealing Device (TULAB) during Robotic Surgery for Gastric Cancer: Enhancing the Surgeon’s Eye for Reduced-Port Robotic Gastrectomy

Background: Docking the scope and instruments through a multi-channel trocar has enabled reduced-port robotic distal gastrectomy (RRDG) for gastric cancer. To facilitate lymphadenectomy over the anatomical hindrances during RRDG, we recently introduced the Vessel Sealer Extend® (VSE) (Intuitive Surgical, Sunnyvale, CA, USA), a bipolar vessel-sealing device (BVSD) with an articulating jaw. Methods: From May 2020 to August 2023, we performed RRDG to treat T1 gastric cancer. One endoscope arm and three instrument arms of the da Vinci® Xi Surgical System (Intuitive Surgical) were used. During the lymphadenectomy, the endoscope and VSE (Intuitive Surgical) were docked through a multi-channel trocar established on a trans-umbilical incision. Two Cardiere forceps were docked through cannulas established on each flank. A trans-umbilical lymphadenectomy using an articulating BVSD (TULAB) was then performed. Results: A total of 42 patients underwent planned RRDG with the TULAB technique. The number of retrieved lymph nodes did not differ between the patients who underwent RRDG and those who underwent conventional laparoscopic distal gastrectomies (CLDG) (p = 0.362). There was no statistically significant difference in postoperative complications between the RRDG and CLDG group (p = 0.189). The mean time to first semi-fluid diet was shorter in the patients who underwent RRDG than CLDG (p = 0.030), and the incidence of postoperative ileus was lower in the RRDG group than the CLDG group (0% and 9.9%, respectively, p = 0.034). Conclusions: Despite use of fewer ports, RRDG with TULAB had similar outcomes to CLDG in terms of the incidence of postoperative morbidity and the number of harvested lymph nodes. Furthermore, by reducing the number of incisions, the incidence of the intra-abdominal adhesions can potentially be lowered when RRDG is used

Characteristics and Clinical Course of Dysphagia Caused by Anterior Cervical Osteophyte

Objective To investigate swallowing characteristics of patients with dysphagia caused by anterior cervical osteophytes (ACOs) and compare clinical courses according to treatment options. Methods A retrospective analysis of 1,866 videofluoroscopic swallowing studies (VFSS) of patients with ACOs from electronic medical records was performed. Patients with other diseases that could explain the dysphagia were excluded. Dysphagia characteristics and severity and clinical and radiological characteristics of subjects with ACOs were evaluated. Dysphagia characteristics and clinical course were compared among three treatment groups: surgical treatment, swallowing rehabilitation, and conservative treatment. Results Subjects were 22 men and 1 woman with a mean age of 78.69±8.01 years. The mean osteophyte thickness was 9.07±3.84 mm. It was significantly thicker in the surgical group than that in other groups (p=0.01). ACOs were most frequently found at C5 level. This level also had the thickest osteophytes. However, videofluoroscopic dysphagia scales (VDS) were not significantly different among the three treatment groups. The pharyngeal phase score of the VDS was significantly higher in the surgical group (p=0.041). Dysphagia severity was decreased significantly in the surgical group at 3 months after the initial VFSS (p=0.004). Conclusion The main swallowing characteristics in patients with ACOs were dysphagia features of the pharyngeal phase, including inappropriate airway protection, decreased laryngeal elevation, and reduced epiglottis inversion. When determining treatment options, it may be helpful to consider dysphagia severity at pharyngeal phase and osteophyte thickness

First-line chemotherapy with irinotecan plus capecitabine for advanced colorectal cancer

OBJECTIVE: The aim of this study was to evaluate efficacy and safety of the combination chemotherapy with irinotecan plus capecitabine in patients with advanced colorectal adenocarcinoma. METHODS: Patients with histologically proven advanced colorectal adenocarcinoma received a first-line chemotherapy with irinotecan 240 mg/m2 on day 1 and capecitabine 2,000 mg/m2/day as an intermittent regimen of 2 weeks of treatment followed by a 1-week rest. Treatment was repeated every 3 weeks. RESULTS: Thirty-nine patients were registered, and 36 were assessable for responses. Sixteen objective responses (44%) were observed with a median response duration of 6.9 months. Stable disease was documented in 14 cases (39%). The median time to progression was 6.7 months. The median overall survival was not reached at the time of analysis, and the 1-year survival rate was 67%. Two patients died: 1 due to sepsis not complicating myelosuppression, and 1 patient, known as a hepatitis B virus carrier prior to chemotherapy, died of hepatic failure, the cause of which was not clinically verified. Frequently encountered therapy-related events were leukopenia and gastrointestinal side effects including diarrhea. Severe hand-and-foot syndrome was observed in only 1 patient. CONCLUSIONS: The combination chemotherapy of irinotecan and capecitabine is an active and tolerable regimen for advanced colorectal adenocarcinoma, but the observed deaths suggest a future randomized trial that requires a cautious patient selection

Self-Oxidation Resistance of the Curved Surface of Achromatic Copper

Copper surfaces that exhibit a wide range of achromatic colors while still metallic have not been studied, despite advancements in antireflection coatings. A series of achromatic copper films grown with [111] preferred orientation by depositing 3D porous nanostructures is introduced via coherent/incoherent atomic sputtering epitaxy. The porous copper nanostructures self-regulate the giant oxidation resistance by constructing a curved surface that generates a series of monoatomic steps, followed by shrinkage of the lattice spacing of one or two surface layers. First-principles calculations confirm that these structural components cooperatively increase the energy barrier against oxygen penetration. The achromaticity of the single-crystalline porous copper films is systematically tuned by geometrical parameters such as pore size distribution and 3D linkage. The optimized achromatic copper films with high oxidation resistance show an unusual switching effect between superhydrophilicity and superhydrophobicity. The tailored 3D porous nanostructures can be a candidate material for numerous applications, such as antireflection coatings, microfluidic devices, droplet tweezers, and reversible wettability switches

Overview of the KoRIA Facility for Rare Isotope Beams

The Korea Rare Isotope Accelerator, currently referred to as KoRIA, is briefly presented. The KoRIA facility is aimed to enable cutting-edge sciences in a wide range of fields. It consists of a 70 kW isotope separator on-line (ISOL) facility driven by a 70 MeV, 1 mA proton cyclotron and a 400 kW in-flight fragmentation (IFF) facility. The ISOL facility uses a superconducting (SC) linac for post-acceleration of rare isotopes up to about 18 MeV/u, while the SC linac of IFF facility is capable of accelerating uranium beams up to 200 MeV/u, 8 p mu A and proton beams up to 600 MeV, 660 mu A. Overall features of the KoRIA facility are presented with a focus on the accelerator design.close5