Explore the vast range of titles available.

In this randomized trial, patients undergoing hemodialysis who had native upper-extremity arteriovenous fistula stenosis received drug-coated or standard balloon angioplasty after initial successful transluminal angioplasty. The drug-coated balloon was superior to the standard balloon and was noninferior with respect to access circuit-related serious adverse events.

Anatomically complex airway stenosis (ACAS) represents a challenging situation in which commercially available stents often result in migration or granulation tissue reaction due to poor congruence. This proof-of-concept clinical trial investigated the feasibility and safety of computer-assisted designed (CAD) and manufactured personalised three-dimensional (3D) stents in patients with ACAS from various origins. After CAD of a virtual stent from a CT scan, a mould is manufactured using a 3D computer numerical control machine, from which a medical-grade silicone stent is made. Complication rate, dyspnoea, quality of life and respiratory function were followed after implantation. The congruence of the stent was assessed peroperatively and at 1 week postimplantation (CT scan). The stent could be implanted in all 10 patients. The 3-month complication rate was 40%, including one benign mucus plugging, one stent removal due to intense cough and two stent migrations. 9 of 10 stents showed great congruence within the airways, and 8 of 10 induced significant improvement in dyspnoea, quality of life and respiratory function. These promising outcomes in highly complex situations support further investigation on the subject, including technological improvements.​Trial registration number NCT02889029.

Debulking techniques are often necessary for successful lesion preparation in percutaneous coronary intervention. The aim of this study was to compare plaque modification of severely calcified lesions by coronary intravascular lithotripsy (IVL) with that of rotational atherectomy (RA) using optical coherence tomography (OCT). ROTA.shock was a 1:1 randomized, prospective, double-arm, multicenter noninferiority trial designed to compare final minimal stent area after IVL with RA for lesion preparation in percutaneous coronary interventional treatment of severely calcified lesions. On the basis of OCT acquired before and immediately after IVL or RA in 21 of the 70 patients included, we performed a detailed analysis of the modification of the calcified plaque. After RA and IVL, calcified plaque fractures were present in 14 of the patients (67%), with a significantly greater number of fractures after IVL (3.23 ± 0.49) than after RA (1.67 ± 0.52; p < 0.001). Plaque fractures after IVL were longer than after RA (IVL: 1.67 ± 0.43 mm vs RA: 0.57 ± 0.55 mm; p = 0.01), resulting in a greater total volume of the fractures (IVL: 1.47 ± 0.40 mm3 vs RA: 0.48 ± 0.27 mm3; p = 0.003). Use of RA was associated with a greater acute lumen gain than was use of IVL (RA: 0.46 ± 0.16 mm2 vs IVL: 0.17 ± 0.14 mm2; p = 0.03). In conclusion, we were able to show differences in plaque modification of calcified coronary lesions by OCT: although RA leads to a greater acute lumen gain, IVL induces more and longer fractures of the calcified plaque.

In this randomized trial of 39 patients with chronic pancreatitis and a distal obstruction of the pancreatic duct, surgical drainage was more effective at reducing pain than was endoscopic drainage. Complete or partial relief of pain was achieved in 32% of patients assigned to endoscopic treatment and 75% of those assigned to surgery. In patients with chronic pancreatitis and a distal obstruction of the pancreatic duct, surgical drainage was more effective at reducing pain than was endoscopic drainage. In patients with chronic pancreatitis, pain is the predominant symptom and remains a therapeutic challenge. Pancreatic-duct obstruction is considered an important etiologic factor; therefore, ductal decompression is advocated for patients with pain and a markedly dilated duct. Both endoscopic and surgical drainage are treatment options. Surgical drainage is accomplished by longitudinal pancreaticojejunostomy 1 and has a rate of complications of 6 to 30%, a mortality rate of 0 to 2%, and a success rate in achieving long-term pain relief of 65 to 85%. 2 – 9 Endoscopic drainage involves sphincterotomy, dilation of strictures, and removal of stones and has a success rate of . . .

The response of Crohn's disease (CD) stricture to endoscopic therapy compared with non-CD stricture is unknown. Our aim was to compare the short- and long-term outcomes of endoscopic management of those strictures.MethodsAll eligible patients with benign non-CD strictures who underwent the endoscopic balloon dilation between January 2002 and September 2013 were included. Patients with CD strictures were randomly selected with a ratio (CD versus non-CD strictures) of 2:1.ResultsA total of 90 patients were included, including 30 (33.3%) with non-CD strictures and 60 (66.7%) with CD strictures. Patients with CD strictures were younger than those with non-CD strictures at the time of disease diagnosis (25.8 ± 11.1 versus 50.5 ± 17.5; P < 0.001) and at the time of the first dilation (43.9 ± 12.4 versus 55.8 ± 13.9; P < 0.001). There were no significant differences in characteristics of strictures and their endoscopic treatments between the CD and non-CD groups, except for the percentage of patients who were ever treated with intralesional corticosteroid injection (25.0% versus 6.7%, P = 0.046). Patients in the 2 groups had similar technical success rates (94.0% versus 93.9%, P = 1.00). Few patients in CD stricture group required emergency room visits due to obstructive symptoms from recurrence of disease (1.7% versus 16.7%, P = 0.02). There were on procedure-related complications in either of the 2 groups.ConclusionsThe efficacy and safety of endoscopic balloon dilation in the treatment of CD and non-CD strictures seemed to be comparable.

Current treatment of ischaemic stroke with thrombolytic therapy is restricted to 3–4·5 h after symptom onset. We aimed to assess the safety and efficacy of desmoteplase, a fibrin-dependent plasminogen activator, given between 3 h and 9 h after symptom onset in patients with occlusion or high-grade stenosis in major cerebral arteries. In a prospective, double-blind, multicentre, parallel-group, randomised trial, we enrolled patients from 77 hospitals in 17 countries who had ischaemic stroke and occlusion or high-grade stenosis in major cerebral arteries. We randomly assigned patients in a 1:1 ratio, using computer-generated randomisation lists with stratification for baseline National Institutes of Health Stroke Scale and age, to treatment with desmoteplase (90 μg/kg) given 3–9 h after symptom onset or to placebo. Patients, investigators, staff, and the funder were masked to treatment assignment. The primary outcome was a favourable modified Rankin Scale score (0–2) at day 90 in all treated patients who had at least one postbaseline measurement of the modified Rankin Scale. Safety was assessed in all randomly assigned patients who received study drugs. This trial is registered with ClinicalTrials.gov, number NCT00790920. Between Feb 6, 2009, and Nov 27, 2013, we enrolled 492 patients and randomly assigned 247 to desmoteplase and 245 to placebo (236 in the desmoteplase group and 237 in the placebo group were included in the analysis of the primary endpoint). Median time from stroke onset to treatment was 6·9 h (IQR 5·7–8·0) for placebo and 7·0 h (6·0–7·9) for desmoteplase. Modified Rankin Scale score (0–2) at day 90 occurred in 121 (51%) patients given desmoteplase and 118 (50%) patients given placebo (adjusted odds ratio 1·20, 95% CI 0·79–1·81, p=0·40). 24 (10%) of 240 patients given desmoteplase died compared with 23 (10%) of 238 patients given placebo. Serious adverse events occurred in 64 (27%) of 240 patients receiving desmoteplase compared with 69 (29%) of 238 patients receiving placebo; frequency of symptomatic intracranial haemorrhage (six [3%] patients in the desmoteplase group vs five [2%] in the placebo group), symptomatic cerebral oedema (five [2%] vs four [2%]), and major haemorrhage (ten [4%] vs 15 [6%]) was much the same between treatment groups. Treatment with desmoteplase did not cause safety concerns and did not improve functional outcome when given to patients who had ischaemic stroke and major cerebral artery occlusion beyond 3 h of symptom onset. H Lundbeck A/S.

Intractable advanced lung cancer can be treated palliatively with photodynamic therapy (PDT) combined with chemotherapy to remove central and peripheral (lobar or segmental bronchi) bronchial stenosis and obstruction. We present data for 12 (eight men, four women) consecutive patients with 13 advanced non-small cell lung carcinomas in whom curative operations were contraindicated, who underwent PDT combined with chemotherapy for local control of the intraluminal lesions. The mean age was 73.3 years (range, 58–80 years), and the stages of cancer were IIA–IV. The median stenosis rates before treatment, one week post-treatment, and one month post-treatment were 60% (range, 30%–100%), 15% (range, 15%–99%), and 15% (range 15%–60%), respectively. The mean and median survival times were 9.3 and 5.9 months, respectively. The overall 1-year survival rate was 30.0%. No PDT-related morbidity or mortality occurred. In this single-institution study, all patients experienced improved symptoms and quality of life at one week after treatment; furthermore, an objective response was evidenced by the substantial increase in the openings of the bronchial lumen and prevention of obstructive pneumonia. Therefore, PDT with chemotherapy was useful and safe for the treatment of bronchial obstruction.

Background Lumbosacral canal stenosis is known as the most common cause of back surgery with several complications. Selecting a minimally invasive treatment with high efficacy in such patients is necessary. This study was designed to evaluate the effectiveness of ozone therapy in combination with caudal epidural steroid in patients with lumbar spinal stenosis. Methods A double-blind randomized clinical trial was conducted on 50 patients with lumbar spinal stenosis allocated into two study groups. Under ultrasound guidance, the first group received 80 mg of triamcinolone hexavalent with 4 mL of Marcaine 0.5% and 6 mL of distilled water to the caudal epidural space. The second group received an injection similar to the first group, combined with 10 mL of ozone (O2-O3) gas at a concentration of 10 µg/cc. The patients were followed at baseline, one, and six months after injection with clinical outcomes measures using Visual Analog Scale (VAS), Walking Distance (WD) and Oswestry Disability Index (ODI). Results The mean age of subjects, 30 males (60%) and 20 females (40%), was reported as 64.51 ± 7.19 years old. Reduction of pain intensity based on VAS score was statistically significant in both groups at follow-up periods (P < 0.001). The VAS changes in the first month and sixth months showed no significant difference between the two groups (P = 0.28 and P = 0.33, respectively). The improvement in disability index (ODI) in both types of treatment during follow-up was significant (P < 0.0001), and there was no difference between the two treatment groups in one month and six months (P = 0.48 and P = 0.88, respectively). As for walking distance, the improvement process with both types of treatment during follow-up periods was significant (P < 0.001). However, after one and six months of treatment, the rate of improvement in patients’ walking distance in the caudal epidural steroid injection plus ozone group was significantly higher than in the epidural steroid group (p = 0.026 and p = 0.017, respectively). Conclusions In this study, the results of VAS and ODI outcomes showed that caudal epidural steroid injection combined with ozone has no advantage over caudal epidural steroid injection alone. Interestingly, our results demonstrated that the group receiving caudal epidural steroid injection plus ozone scored significantly higher on the walking distance index than the group receiving caudal epidural steroid alone. Trial Registration IRCT IRCT20090704002117N2 (registration date: 07/08/2019).

Background This study was a randomized controlled trial to evaluate efficacy and safety of the usage of intravenous tranexamic acid during posterior operation of multilevel thoracic spine stenosis for controlling perioperative blood loss. Methods Sixty eight patients with multilevel thoracic spine stenosis were randomized into the tranexamic acid group receiving 15 mg/kg body weight before the skin incision was made and 1 mg/kg body weight per hour during operation or the control group receiving the same dose of placebo (0.9% sodium chloride solution) intravenously. Pedicle screw fixation, laminectomy and selective discectomy were performed. Intraoperative and perioperative total blood loss were compared. The necessity and amount for blood transfusion, blood coagulation function, durations of postoperative hospital stays were compared. The complications of tranexamic acid were also investigated such as cardiovascular and cerebrovascular events, lower limb venous thrombosis. Results There were no statistically significant differences in age, gender, body mass index, ASA status, pathology required surgery, preoperative hemoglobin, operation time, laminectomy segments and discectomy segments between the tranexamic acid and control groups. The intraoperative blood loss (455.9 ± 206.6 ml vs 580.6 ± 224.3 ml, p  < 0.05) and total blood loss (675.3 ± 170.3 ml vs 936.8 ± 306.4 ml, p  < 0.01) in tranexamic acid group were significant lower than those in control group. The means of blood unit transfused (2.5 ± 1.0 vs 4.7 ± 2.4, p  < 0.05) and Hb reduction in 48 h (22.5 ± 3.4 g/L vs 25.3 ± 3.9 g/L, p  < 0.01) were significantly lower in tranexamic acid group than that in control group. There were no statistically significant differences in blood coagulation function pre-operation or 48 h post-operation between the tranexamic acid and the control groups. The requirements for patients to receive blood transfusion were fewer and durations of post-operational hospital stays were shorter in the tranexamic acid group, however, the difference did not achieve statistical significance. There was no significant difference in superficial or deep venous thrombosis of lower limbs or deterioration of neurological function between tranexamic acid group and control group. Conclusions Application of intravenous tranexamic acid significantly reduces intraoperative and perioperative total blood loss without significant side effects in posterior operation of multilevel thoracic spine stenosis. Trial registration At Chinese Clinal Trial Registry. http://www.chictr.org.cn/ , ChiCTR2100054221. Registered on 11/12/2021.

Purpose To evaluate the treatments of a short-segment atherosclerotic stenosis in the superficial femoral arteries with the cutting balloon angioplasty (CBA) versus conventional balloon angioplasty [percutaneous transluminal angioplasty (PTA)] in a randomized controlled trial. Material and Methods The study group comprised 60 patients (33 men, 27 women; average age 64 years) with a short (≤5 cm) focal SFA de novo atherosclerotic stenosis associated with a history of intermittent claudication or rest pain. The primary end point of this study was the rate of binary restenosis in the treated segment 12 months after the intervention. All patients were evenly randomized to either the PTA or CBA treatment arms. Follow-up angiograms and ankle–brachial index (ABI) measurements were performed after 12 months. The evaluation of the restenosis rates and factors influencing its occurrence were calculated by logistic regression analysis. Results In the intention-to-treat analysis, restenosis rates after 2-month follow-up were 9 of 30 (30 %) in the PTA group and 4 of 30 (13 %) in the CBA group ( p  = 0.117). In the actual treatment analysis, after exclusion of patients who required nitinol stent placement for a suboptimal result after angioplasty alone (5 patients in the PTA group and none in the CBA group), restenosis rates were 9 of 25 (36 %) and 4 of 30 (13 %), respectively ( p  = 0.049). In the intention-to-treat analysis there were also significant differences in ABI values between the PTA and CBA groups at 0.77 ± 0.11 versus 0.82 ± 0.12, respectively ( p  = 0.039), at 12 months. Conclusion Based on the presented results of the trial, CBA seems to be a safer and more effective than PTA for treatment of short atherosclerotic lesions in the superior femoral artery.