Clinical and angiographic outcomes up to three years after coronary-artery stenting were favorable, with a low rate of revascularization of the stented lesions. Late improvement in luminal diameter appears to occur between six months and three years.
Accumulated evidence has revealed that endoscopic ultrasonography (EUS) has had a great impact on the clinical evaluation of pancreatic cancers. EUS can provide high-resolution images of the pancreas with a quality regarded as far surpassing that achieved on transabdominal ultrasound (US), computed tomography (CT), or magnetic resonance imaging (MRI). EUS is particularly useful for the detection of small pancreatic lesions, while EUS and its related techniques such as contrast-enhanced EUS (CE-EUS), EUS elastography, and EUS-guided fine needle aspiration (EUS-FNA) are also useful in the differential diagnosis of solid or cystic pancreatic lesions and the staging (T-staging, N-staging, and M-staging) of pancreatic cancers. In the diagnosis of pancreatic lesions, CE-EUS and EUS elastography play a complementary role to conventional EUS. When sampling is performed using EUS-FNA, CE-EUS and EUS elastography provide information on the target lesions. Thus, conventional EUS, CE-EUS, EUS elastography, and EUS-FNA are essential in the clinical investigation of pancreatic cancer.
To understand remodeling of human coronary arteries undergoing coronary angioplasty or atherectomy, serial intravascular ultrasonographic examinations were performed at preintervention and postintervention examinations and at 24 hours, 1 month, and 6 months. Complete serial data were obtained in 61 lesions (balloon angioplasty, 35 lesions; directional atherectomy, 26 lesions). Lumen area improved from 6.81+/-2.24 mm2 after intervention to 8.22+/-2.79 mm2 at 1 month (P=.0001) and decreased to 4.88+/-2.86 mm2 at 6 months (P=.0001). Vessel area enlarged from 17.32+/-5.35 mm2 after intervention to 19.39+/-5.33 mm2 at 1 month (P=.0001) and decreased to 16.33+/-5.54 mm2 at 6 months (P=.0001). Plaque+media area increased significantly from postintervention examination to 24 hours (10.51+/-4.38 versus 10.96+/-4.49 mm2, P=.0008) and from 24 hours to 6 months (10.96+/-4.49 versus 11.45+/-4.45 mm2, P=.03). Changes in lumen area in each study interval correlated more closely with changes in vessel area than with changes in plaque+media area. Restenotic lesions compared with nonrestenotic lesions had a greater decrease in the vessel area between 1 month and 6 months (-4.33+/-2.73 versus -2.49+/-2.15 mm2, P=.006) and greater increase in the plaque+media area both within 24 hours (0.84+/-1.22 versus 0.27+/-0.38 mm2, P=.04) and between 24 hours and 6 months (1.19+/-2.19 versus 0.18+/-1.46 mm2, P=.04). CONCLUSIONS; Remodeling after coronary angioplasty or atherectomy was characterized by early adaptive enlargement and late constriction of the vessel.
Introduction
Our group has conducted extensive basic and preclinical studies of the use of human induced pluripotent cell (iPSC)-derived neural stem/progenitor cell (hiPSC-NS/PC) grafts in models of spinal cord injury (SCI). Evidence from animal experiments suggests this approach is safe and effective. We are preparing to initiate a first-in-human clinical study of hiPSC-NS/PC transplantation in subacute SCI.
Setting
NS/PCs were prepared at a Good Manufacturing Practice-grade cell processing facility at Osaka National Hospital using a clinical-grade integration-free hiPSC line established by the iPSC Stock Project organized by the Kyoto University Center for iPS Cell Research and Application. After performing all quality checks, the long-term safety and efficacy of cells were confirmed using immunodeficient mouse models.
Methods
The forthcoming clinical study uses an open-label, single-arm design. The initial follow-up period is 1 year. The primary objective is to assess the safety of hiPSC-NS/PC transplantation in patients with subacute SCI. The secondary objective is to obtain preliminary evidence of its impact on neurological function and quality-of-life outcomes. Four patients with C3/4-Th10 level, complete subacute (within 24 days post-injury) SCI will be recruited. After obtaining consent, cryopreserved cells will be thawed and prepared following a multi-step process including treatment with a γ-secretase inhibitor to promote cell differentiation. A total of 2 × 10
6
cells will be transplanted into the injured spinal cord parenchyma 14–28 days post-injury. Patients will also receive transient immunosuppression. This study protocol has been reviewed and approved by the Certified Committee for Regenerative Medicine and the Japanese Ministry of Health, Labor and Welfare (University Hospital Medical Information Network Clinical Trials Registry [UMIN-CTR] number, UMIN000035074; Japan Registry of Clinical Trials [jRCT] number, jRCTa031190228).
Discussion/conclusion
We plan to start recruiting a patient as soon as the COVID-19 epidemic subsides. The primary focus of this clinical study is safety, and the number of transplanted cells may be too low to confirm efficacy. After confirming safety, a dose-escalation study is planned.
This single-center comparative randomized superiority study compared biliary stenting using fully covered selfexpandable metal stents (FCSEMS) and biliary stenting using plastic stents (PS) in preoperative biliary drainage of patients with borderline resectable pancreatic cancer (BRPC) who are planned to undergo a single regimen of neo-adjuvant chemotherapy (NAC).Methods: Twenty-two patients with BRPC who required preoperative biliary drainage before NAC (Gemcitabine plus Nabpaclitaxel) were randomly assigned 1:1 to the FCSEMS or PS group. The primary endpoint was the rate of stent dysfunction until surgery or tumor progression. Secondary endpoints were stent patency, number of re-interventions, adverse events of endoscopic retrograde biliary drainage (EBD), operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs.Results: Eleven patients in each of the groups reached the primary endpoint. The FCSEMS group showed a significantly lower rate of stent dysfunction (18.2% vs. 72.8%, P = 0.015), longer stent patency (P = 0.02), and lower number of reinterventions for stent dysfunction (0.27 AE 0.65 vs. 1.27 AE 1.1, P = 0.001) than the PS group. The adverse events of EBD, operation time, volume of intraoperative bleeding, postoperative hospitalization, postoperative adverse events and medical costs did not significantly differ between the two groups.Conclusions: In patients with BRPC for preoperative biliary drainage, stent dysfunction occurred less frequently with FCSEMSs than with PSs. In addition, FCSEMS and PS provided similar preoperative management of BRPC in terms of the safety of surgery and medical costs. (UMIN ID000030473).
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