Efficacy and safety of a novel hydrogel (HYADD4-G) in degenerative disc disease patients: a multicentric open label study.

OBJECTIVE: In this premarket clinical study, we evaluated the efficacy and safety of a novel Hydrogel (HYADD4-G) for reducing low back pain (LBP) in patients with degenerative disc disease (DDD). PATIENTS AND METHODS: Twenty-three patients with chronic LBP were enrolled. All patients presented with up to three lumbar black discs (Pfirrmann grade III or IV), LBP of at least 40 mm on the Visual Analogue Scale (VAS), and a Roland-Morris Disability Questionnaire (RMDQ) score of at least 9. Patients received a single 1.5 ml intradiscal injection of HYADD4-G (8 mg/ml), guided by X-ray. Our primary endpoint was the change in VAS score from baseline (day 0) to 4, 12, and 24 weeks. Our secondary endpoints were black disc hydration by Magnetic Resonance Imaging (MRI); the patient's therapeutic response according to the RMDQ; the quality of life, as determined by the EuroQol-5 Dimension (EQ-5D) Index; and a global assessment of patient health status, safety, and local tolerability. RESULTS: Compared with baseline values, VAS score showed a significant reduction at each time point, and across the overall 24-week follow-up period (p < 0.0001). MRI scanning observed a significant reduction in Pfirrmann grade from baseline, by at least one grade, at both week 4 (p = 0.0039) and week 24 (p = 0.0010). Furthermore, compared with baseline values, there was a significant reduction in RMDQ score at each timepoint, and across the entire study period (p < 0.0001). The EQ-5D index increased significantly from baseline to week 24 (p = 0.0001). Finally, mean VAS scores for Patient Global Assessment (PTGA), and Clinical Observer Global Assessment (COGA), decreased significantly at each time point (p < 0.0001), except for week 4. CONCLUSIONS: HYADD4-G proved to be an efficient reliever of low back pain due to DDD.

Coma with Vertical Gaze Palsy: Relevance of Angio-CT in Acute Percheron Artery Syndrome.

BACKGROUND: A 63-year-old woman with chronic atrial fibrillation treated with warfarin was admitted to emergency for coma and complete vertical gaze palsy. Investigations: Brain CT and MRI, echo-colour Doppler sonography of the supraaortic vessels, angio-CT of the intracranial vessels, EEG, transesophageal echocardiogram, biohumoral tests. Brain CT and MRI scans showed bilateral thalamic lesions with involvement of the right midbrain; EEG showed a diffuse alpha rhythm prevalent on the posterior regions; echo-colour Doppler sonography of the supraaortic vessels showed marked reduction of blood flow in the right vertebral artery; angio-CT scans showed occlusion of the right vertebral artery and a significant filling defect of the first part of the right posterior cerebral artery (P1) from which the artery of Percheron arises. A follow-up angio-CT showed a complete recanalization of P1. Diagnosis: Percheron artery syndrome. Treatment and Management: Aspirin, neurorehabilitation.

Diagnostic accuracy of 64-slice computed tomography coronary angiography in a large population of patients without revascularisation: registry data and review of multicentre trials.

PURPOSE: This study was undertaken to evaluate the diagnostic accuracy of computed tomography coronary angiography (CT-CA) for the detection of significant coronary artery stenosis (> or =50% lumen reduction) compared with conventional coronary angiography (CCA) in a registry and to review major multicentre trials. MATERIALS AND METHODS: A total of 1,372 patients (882 men, 490 women; mean age 59.3+/-11.9 years) in sinus rhythm were studied with CT-CA (64-slice technology) and CCA. The diagnostic accuracy of CT-CA was evaluated against quantitative CCA as a reference standard for coronary artery stenosis. Positive and negative likelihood ratios and inter- and intraobserver agreement were calculated. RESULTS: The prevalence of disease was 53%. CCA demonstrated the absence of significant coronary artery disease in 46.6% (639/1372), single-vessel disease in 24.7% (337/1372) and multivessel disease in 28.9% (396/1372) of patients. In per-patient analysis sensitivity, specificity and positive and negative predictive value of CT-CA were 99% [confidence interval (CI) 97-99], 92% (CI 89-94), 94% (CI 91-95) and 99% (CI 97-99), respectively. Per-patient and per-segment likelihood ratios (LR+=12.4 and LR-=0.011; LR+=18.3 and LR-=0.064, respectively), were good. Inter- and intraobserver variability was 0.78 and 0.85, respectively. CONCLUSIONS: CT-CA is a reliable diagnostic modality both in terms of sensitivity and negative predictive value. Differences in trial results are also due to the different parameters used for patient inclusion.

Regional combined with systemic chemotherapy in unresectable biliary tract cancers: a phase II study.

Unresectable biliary tract cancers have a very poor prognosis. No good systemic chemotherapeutic regimen is available. This study aimed to evaluated the activity and toxicity of a novel approach of combined loco-regional and systemic chemotherapy. Twenty four patients with advanced or metastatic biliary tumors were treated with epiadriamycin 50 mg/m2 and cisplatin 60 mg/m2 administered bolus in proper hepatic artery on day 1, combined with systemic continuous infusion of 5-fluorouracil 200 mg/m2/day, from day 1 to day 14, every 3 weeks. The overall response rate was 8/24 (33%), including one complete response and 7 partial responses (stable disease 46%, progression 21%). The treatment was well tolerated with a minimal hematological toxicity; the major clinical problem was the deep venous thrombosis related to central venous catheter, that occurred in 5 patients (21%). Median overall survival was 14,6 months and 1-year and 2-year survival were 54% and 38% respectively. Performance status improved in 33% of patients and weight gain more than 7% was observed in 17%. This novel combined loco-regional and systemic chemotherapeutic regimen is active and safe for advanced biliary tract cancer patients.

Peribulbar anesthesia with either 0.75% ropivacaine or a 2% lidocaine and 0.5% bupivacaine mixture for vitreoretinal surgery: a double-blinded study.

UNLABELLED: No study has evaluated the efficacy of ropivacaine in peribulbar block for ophthalmic surgery. The purpose of this prospective, randomized, double-blinded study was to compare ropivacaine and a lidocaine-bupivacaine mixture in peribulbar anesthesia. Sixty ASA physical status I or II patients scheduled for elective vitreoretinal surgery were randomized to receive a peribulbar block with 8 mL of either 0.75% ropivacaine (ropivacaine group, n = 30) or a 1:1 mixture of 2% plain lidocaine and 0.5% plain bupivacaine (lido-bupivacaine group, n = 30). Time required for onset of surgical anesthesia, quality of postoperative analgesia, incidence of side effects, and analgesic consumption were recorded. Surgical block was achieved after 8 +/- 5 min in the lido-bupivacaine group and after 10 +/- 5 min in the ropivacaine group (P = 0.23). A 3-mL supplemental injection 15 min after block placement was required in 6 patients in the lido-bupivacaine group (20%) and in 10 patients in the ropivacaine group (33%) due to inadequate motor block (P = 0.38). On Postoperative Day 1, 26 patients in the ropivacaine group (87%) reported no pain at the verbal rating score, compared with 18 patients in the lido-bupivacaine group (60%) (P = 0.005). We conclude that 0.75% ropivacaine may be a suitable choice when performing peribulbar anesthesia for vitreoretinal surgery. IMPLICATIONS: Quick onset of block with prolonged postoperative analgesia is an important goal in regional anesthesia for ophthalmic surgery. Evaluating clinical properties of 0.75% ropivacaine and a 1:1 mixture of 2% lidocaine and 0.5% bupivacaine for peribulbar anesthesia, we demonstrated that ropivacaine has an onset similar to that of the lidocaine-bupivacaine mixture and provides a better quality of postoperative analgesia.

Human defunctionalized colon: a histopathological and pharmacological study of muscularis propria in resection specimens.

Despite the regression of "diversion colitis," temporary functional disorders after bowel continuity restoration could be caused by changes in the smooth muscle of excluded segments; however, studies on the muscularis propria have yielded contradictory results. This study was aimed at evaluating possible histopathological changes in muscular layers and motility of the defunctionalized human colon. Ten patients with defunctionalized colorectum (group A) and 10 controls (group B) underwent restorative or primary resection surgery. Strips were taken proximal to the colostomy (specimens A1) and the defunctionalized segment (specimens A2), and from the proximal (specimens B1) and distal extremity (specimens B2) of resected colons. Measurements of the thickness of the muscularis propria and of the volume density of the myenteric plexus, as well as of spontaneous motility and responses to electrical and pharmacological stimulation were taken. The muscularis propria was thicker in A2 than in A1 specimens (P = 0.004) and in B2 than in B1 specimens (P = 0.007). No differences were recorded either in the myenteric plexus volume density or in colonic motility. No differences were recorded in intergroup comparisons. As no structural or functional changes related to defunctionalization were found, clinical disorders after colorectal restoration could rather result from underlying colonic pathology and/or incomplete distal colon resection.

Lipoid pneumonia: a case of cavitary bilateral nodular opacity.

Lipoid pneumonia is a rare disease resulting from the inhalation of fatty or oily materials into the lungs. It can look like acute or chronic pneumonia or a localized granuloma (called paraffinoma). The clinical and radiological features are usually nonspecific and can suggest lung cancer or tuberculosis. As in most cases accidental inhalation of fatty material escapes anamnestic investigation, lipoid pneumonia is rarely diagnosed without invasive intervention. The present study refers to a case of cavitary bilateral nodular opacity due to the accidental inhalation of paraffin oil used as a laxative, whose radiological appearance was quite similar to Wegener's granulomatosis.

[Femoro-popliteal bypass with reversed saphenous vein. Experience in a General Surgery Department]. / Bypass femoro-poplitei in safena invertita. Esperienza di una divisione di chirugia generale.

Femoro popliteal bypass with reversed saphenous vein are "the gold standard" for revascularization of lower extremities with femoro popliteal occlusion. This form of therapy is usually performed in a Vascular Surgery Department. We report the experience of a General Surgery Department, with patency of 90% at two years.

[Early gastric cancer]. / Early gastric cancer.

The authors perform a retrospective analysis of 46 cases of EGC referred to the Surgical Division of Carrara Civic Hospital during the period 1980-1990 who subsequently underwent surgery. Data relating to age, symptomatology and endoscopic examinations were analysed in order to evaluate the real diagnostic penetration of the method in association with tumour biopsy, site, macroscopic aspect, possible lymph node involvement and the histology of lesions. The most frequent form of surgery in this series was subtotal gastrectomy and the 5- and 10-year survival rates, calculated using an actuarial method, were compared with data reported in the literature. The authors conclude by emphasising the need to improve the frequency of diagnosis of gastric cancer at an "early" stage and affirm that gastric resection associated with lymphoadenectomy of 1st and 2nd level lymph nodes is a sufficiently radical operation and less punitive for the patient compared to total gastrectomy given that the 5- and 10-year survival rates are comparable.

[A comparison between traditional mammography and digital with storage phosphors]. / Confronto tra mammografia tradizionale e digitale con fosfori a memoria.

Conventional and digital mammographic images obtained with storage phosphors were compared. The digital images were acquired with high-resolution 3rd-generation (HR III) screens and specifically adapted algorithms. The experience was made both on a phantom and in vivo. The phantom study was carried out by comparing conventional with digital radiographs acquired with: a) same kV (28) and same mAs; b) same kV (24) and same mAs; c) 28 kV with 30% mAs reduction, in digital images only. The results obtained upon counting the amount of recognizable details per image demonstrated slight loss of information in digital radiographs only when mAs was reduced by 30%. Two hundred patients were studied; they were divided into four groups according to the type of breast (medium inherent contrast or solid breast) and to exposure factors. After conventional mammography, an additional digital radiograph was performed using one of the three techniques previously employed on the phantom. Separately, 10 ductogalactographies and 10 magnification radiographs of microcalcifications were compared; the same exposure factors were used in these images too. The radiographs were viewed by three expert mammographic radiologists; contrast quality and spatial resolution were investigated and a score was given to each image on a 3-grade scale (insufficient, sufficient, good). The comparison of the mean values obtained showed higher contrast and better enhancement of nodular lesions on digital images, on which, however, the depiction of microcalcifications was worse than on conventional radiographs, especially with lower radiation doses, even though the number of detected microcalcifications was the same.

[The computed tomographic diagnosis of malignant pleural mesothelioma. A multicenter study]. / Diagnosi con Tomografia Computerizzata del mesotelioma pleurico maligno. Studio multicentrico.

CT features are described and accuracy of the method is discussed in the diagnosis of malignant pleural mesothelioma. Ninety-eight patients suffering from pleural disease mimicking mesothelioma were examined by means of III-generation CT scanners; according to the final diagnosis, 37 patients suffered from malignant pleural mesothelioma, 27 from other malignant pleural diseases and 34 from various benign diseases. In all patients a series of CT signs was evaluated: pleural thickening patterns, lesion spread and possible associated characters. In the diagnosis of mesothelioma CT showed 72.5% sensitivity, 63.8% specificity, 68.3% diagnostic accuracy, 68.5% positive predictive value and 68.2% negative predictive value. Some significant CT patterns in distinguishing malignant from benign pleural disease were identified, while the characterization of malignant disease (mesothelioma versus other neoplastic conditions) proved to be unreliable.

[Radiologic study of the thorax using the digital method (FCR 101). Evaluation of various parameters as related to exposure]. / Studio radiologico del torace con metodica digitale (FCR 101). Valutazione di alcuni parametri in relazione alla esposizione.

A computed radiography system with solid state detectors (FCR 101) was employed to evaluate the quality of digital images, with optimal and progressively lowered doses, in the study of the chest. Routine chest radiographs of in patients with no pathologic conditions of the chest were studied. The patients were divided into 3 groups: each patient in group A underwent two radiographs, one at 100% and the other at 50% exposure; patients in group B were imaged with 100% and 25% doses, and those in group C received 50% and 25% exposure. Several parameters were employed for image evaluation, and a value was given to each of them (1 = good, 2 = sufficient, 3 = insufficient). Upon comparison of the average values obtained, we observed that the digital technique allowed a most accurate and well-defined representation of the examined parameters at 100% exposure dose and that a 50% reduction did not decrease the informative content in the least. A 25% reduction, however, determined a high degree of background noise and a subsequent, though slight, loss of information.

[Double-contrast enema. Study of the mucosal pattern and the organ profile with conventional and digital methods]. / Clisma a doppio contrasto. Studio del disegno mucoso e del profilo d'organo con le metodiche tradizionale e digitale.

A solid state digital system (FCR 101) was employed in our comparative evaluation of the image quality of conventional versus digital techniques in the study of colon by means of double-contrast enema. Sixty patients were examined with a single AP view, using digital radiography with 100% radiation dose and progressive 50% and 75% reductions; the radiographs thus obtained were then compared with the corresponding conventional ones. The examined parameters were organ profile and mucosal pattern. Each digital and conventional radiograph was evaluated by 2 independent radiologists and a value was given to each parameter i.e., 1 = good, 2 = sufficient, 3 = insufficient. Upon comparison of the average values obtained for digital and conventional radiographs in optimal conditions and with a dose reduced by 50%, the digital technique was seen to give a more detailed and accurate representation of both low-contrast mucosal pattern and of organ profile. With the dose reduced by 75%, a slight increase was observed in background noise which caused a slight loss in image definition, but this did not reduce image readability with respect to conventional radiographs. To conclude, the digital method with a 50% exposure reduction is to be preferred in the examination of the colon, especially in pediatric radiology; furthermore, since this technique allows better detailing at lower contrast, it is to be preferred in the study of the pathologic conditions affecting mainly/only the mucosal pattern--e.g., cancer, ulcerative colitis, Crohn's disease, and so on. An exposure dose reduced by 75% may be used for following lesions previously diagnosed and when a less detailed depiction of the mucosal pattern is enough.

[Duodenopancreatectomy with conservation of the pylorus]. / Duodenopancreasectomia con conservazione del piloro.

The authors report on their initial experience with pylorus-preserving pancreatoduodenectomy. In the last three years 11 patients with neoplastic disease of the pancreatic head and ampullary region underwent the above mentioned procedure. The surgical technique carefully preserved the blood supply and innervation to the antro-pyloric region and duodenum was transected 2 cm distal to the pylorus. Postoperative mortality was 9%. Postoperative nasogastric suction was required for eight days (median). Long term results are quite good with a satisfactory restoration of intestinal function and a weight gain of 95% of pre-illness weight. At the present time preserving the pylorus appears an usefull modification of Whipple procedure.

[Peritoneal pseudomyxoma. Diagnostic role of CT and ultrasonics]. / Pseudomixoma peritonei. Ruolo diagnostico della TC e della ecografia.

Pseudomyxoma peritonei is an uncommon disorder, usually the sequelae of mucocele or mucinous adenocarcinoma of the appendix or mucinous cistoadenocarcinoma of the ovary. Two cases of pseudomyxoma peritonei were examined by ultrasound and one case by CT. US revealed, in a case, multiple echogenic small masses scattering on the peritoneal surface or floating in ascites. CT showed, in the second case, a huge mass consisting of a low attenuation material with internal septation. Also a perforation of intestinal loops in the mass was demonstrated. CT and US appearance of pseudomyxoma peritonei in our experience and in previously reported cases are discussed.