A Dramatic Response to Second-Line Nivolumab and Ipilimumab in BRAF-V600-Mutated Metastatic Melanoma.

Introduction: Current treatment options for BRAF V600-mutated unresectable stage III/IV melanoma include anti-PD-1 monotherapy or combination with anti-CTLA-4 or anti-LAG-3 agents, BRAF/MEK inhibitors, and clinical trials. The strategy of combination immunotherapy with nivolumab and ipilimumab has shown promising results, achieving higher response rates, longer duration of response, improved progression-free survival, and enhanced overall survival. The optimal sequence of treatments remains a topic of interest, with preliminary data suggesting a greater effectiveness of immunotherapy as the first-line approach. Preclinical trials have indicated that the efficacy of this sequence may be due to the modification of the immune environment by BRAF kinase inhibitors, leading to immune escape by tumor cells and resistance to immune checkpoint inhibitors. Case Presentation: We present a case of a 72-year-old woman with high-burden metastatic melanoma who failed to respond to prior targeted therapy with BRAF/MEK inhibitors and exhibited a successful response to the second-line treatment with ipilimumab and nivolumab. We discuss the potential reasons for this positive outcome contributing to the current debate concerning treatment sequences, resistance mechanisms, and biomarkers predictive of response to immune checkpoint inhibitors in metastatic melanoma. Conclusion: We believe that in few years the therapeutic algorithms in BRAF V600-mutated unresectable stage III/IV melanoma will be more complex since they will define clearly the correct therapeutic sequences with the inclusion of new immune checkpoint inhibitor drugs and multiple predictive biomarkers of response to better select patients eligible to immunotherapy.

Trans-anal irrigation in patients with multiple sclerosis: Efficacy in treating disease-related bowel dysfunctions and impact on the gut microbiota: A monocentric prospective study.

Background: Constipation and faecal incontinence are not so uncommon in patients with multiple sclerosis, impairing quality of life. The gut microbiota is altered in multiple sclerosis patients and likely contributes to disease pathogenesis. Trans-anal irrigation has been proven to allow treatment of neurogenic bowel dysfunction and may affect gut microbiota. Objectives: The primary outcome was trans-anal irrigation effectiveness on constipation and faecal incontinence. The secondary outcome was gut microbiota profiling compared to healthy subjects and during trans-anal irrigation adoption. Methods: We conducted a prospective cohort study on multiple sclerosis patients, screened with Patient Assessment of Constipation Quality of Life questionnaire before undergoing constipation and faecal incontinence scoring, abdomen X-ray for intestinal transit time, compilation of food and evacuation diaries and faecal sample collection for gut microbiota analysis before and after 4 weeks of trans-anal irrigation. Results and Conclusions: Eighty patients were screened of which nearly half had intestinal symptoms. The included population (n = 37) was predominantly composed of women with significantly longer disease duration, higher mean age and disability than the excluded one (p < 0.05). Twelve patients completed the trans-anal irrigation phase, which led to significant improvement of bowel dysfunction symptom-related quality of life, increase in gut microbiota diversity and reduction of the proportions of pro-inflammatory taxa (p < 0.05). Trans-anal irrigation was safe, satisfactory and could help counteract multiple sclerosis-related dysbiosis.

Changes in gut microbiota in the acute phase after spinal cord injury correlate with severity of the lesion.

After spinal cord injury (SCI), patients face many physical and psychological issues including intestinal dysfunction and comorbidities, strongly affecting quality of life. The gut microbiota has recently been suggested to influence the course of the disease in these patients. However, to date only two studies have profiled the gut microbiota in SCI patients, months after a traumatic injury. Here we characterized the gut microbiota in a large Italian SCI population, within a short time from a not only traumatic injury. Feces were collected within the first week at the rehabilitation center (no later than 60 days after SCI), and profiled by 16S rRNA gene-based next-generation sequencing. Microbial profiles were compared to those publicly available of healthy age- and gender-matched Italians, and correlated to patient metadata, including type of SCI, spinal unit location, nutrition and concomitant antibiotic therapies. The gut microbiota of SCI patients shows distinct dysbiotic signatures, i.e. increase in potentially pathogenic, pro-inflammatory and mucus-degrading bacteria, and depletion of short-chain fatty acid producers. While robust to most host variables, such dysbiosis varies by lesion level and completeness, with the most neurologically impaired patients showing an even more unbalanced microbial profile. The SCI-related gut microbiome dysbiosis is very likely secondary to injury and closely related to the degree of completeness and severity of the lesion, regardless of etiology and time interval. This microbial layout could variously contribute to increased gut permeability and inflammation, potentially predisposing patients to the onset of severe comorbidities.

An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction.

BACKGROUND: Transanal irrigation (TAI) has emerged as a key option when more conservative bowel management does not help spinal cord injured (SCI) individuals with neurogenic bowel dysfunction (NBD). AIM: To investigate the short-term efficacy and safety of an electronic TAI system (Navina Smart) in subjects with NBD. DESIGN: We present an open, prospective efficacy study on Navina Smart, in individuals with NBD secondary to SCI, studied at three months. POPULATION: Eighty-nine consecutive consenting established SCI individuals (61 male; mean age 48, range 18-77) naïve to TAI treatment were recruited from ten centres in seven countries. Subjects had confirmed NBD of at least moderate severity (NBD score ≥10). METHODS: Subjects were taught how to use the device at baseline assisted by the Navina Smart app, and treatment was tailored during phone calls until optimal TAI regime was achieved. The NBD score was measured at baseline and at three months follow up (mean 98 days). Safety analysis was performed on the complete population while per protocol (PP) analysis was performed on 52 subjects. RESULTS: PP analysis showed a significant decrease in mean NBD score (17.8 to 10, p<0.00001). In subjects with severe symptoms (defined as NBD score ≥14), mean NBD scores decreased (19.4 to 10.9, p<0.0001). The number of subjects with severe symptoms decreased from 41 (79%) subjects at baseline to 16 (31%) at three months follow-up. Device failure accounted for the commonest cause for loss of data. Side effects possibly related to the device developed in 11 subjects (12%). Discontinuation due to failure of therapy to relieve symptoms was reported by 5 subjects (6%). CONCLUSION: Navina Smart is effective for individuals with NBD, even those with severe symptoms; long-term data will follow. Whilst there were some device problems (addressed by the later stages of subject recruitment) the treatment was generally safe. CLINICAL TRIAL: (ClinicalTrials.gov number NCT02979808).

Elongation of the styloid processes in kidney-transplanted patients: The role of ectopic calcification as possible cause of Eagle syndrome.

Objective: To investigate the relationship between the presence of ectopic calcification in the elongation of the styloid process (SP) and its possible clinical manifestation (Eagle syndrome) in a population of kidney-transplant patients previously treated with hemodialysis.Methods: Digital orthopantomography of 92 kidney-transplanted patients and 68 control subjects were analyzed to measure the length of SPs. Calcium, phosphate, alkaline phosphatase, and parathyroid hormone (PTH) blood levels were also available for comparison.Results: The mean length of SPs was significantly different between groups, as were phosphate and PTH values.Discussion: Renal transplant patients who have been treated with hemodialysis present elongated SPs, presumably due to alterations in phosphate balance and PTH levels. Thus, in cases of orofacial pain in patients with a history of altered bone metabolism, particularly when due to renal insufficiency, Eagle syndrome should be suspected as the main cause of symptoms.

Treatments in neurogenic bowel dysfunctions: evidence reviews and clinical recommendations in adults.

INTRODUCTION: Neurogenic bowel dysfunction (NBD) is an impairment of defecation control due to any nervous system lesion negatively affecting physical health status and quality of life. We aimed at systematically assessing all available evidence on NBD treatment in adults and providing clinical management guidance and recommendations. EVIDENCE ACQUISITION: PICOs and questions (N.=7) were identified by an expert panel. We searched for and retrieved evidence from the PUBMED and EMBASE databases, limited to the English language and the Western countries context, related to any type of setting and published from 2009 to 2019. Health effects, patient values, preferences and resource use were assessed. Of all, only RCTs, observational studies and systematic reviews on adult population (≥18 years) were analyzed. The study was conducted according to PRISMA guidelines and Cochrane recommendations. The effect size, if possible, was calculated for the interpretation of the outcomes, and evidence was assessed through the GRADE method. EVIDENCE SYNTHESIS: Thirty-one studies were included in our qualitative synthesis. Evidence is generally scarce. Most of the outcomes are narratively described and therefore defined by imprecision. Besides, most of the included studies are affected by risk of bias. Digital stimulation was found to be effective in short term follow-up. The pharmacological treatment choice, combined or alone, needs to be balanced case by case considering clinical history, setting of use and bowel management protocol. According to only one RCT supporting evidence mainly in persons affected by spinal cord injury (SCI), trans-anal irrigation (TAI) improves QoL and patient independency with a significant reduction of time spent for defecation and daily bowel program. History of urinary infections predicts the choice of using TAI. Patient-reported efficacy of colostomy alone or in combination with other surgeries appears evident in terms of patient's satisfaction and QoL over time. Nonetheless, perioperative and late complications can occur and may result in reduced acceptability over time. CONCLUSIONS: Evidence is somehow weak and mainly reported in SCI. The systematic use of assistive interventions does not reduce the need of conservative or invasive approaches. Studies are needed on the role of bowel management in protecting patients from complications secondary to NBD in long term follow-ups.

"Imola-Montecatone" subtotal colectomy to improve bowel management in spinal cord injury patients. Retrospective analysis in 19 cases.

STUDY DESIGN: Retrospective single-center study. OBJECTIVES: Persons with spinal cord injury live with neurogenic bowel dysfunction. Difficulties with management of neurogenic bowel can increase over time with age and time post injury, with a negative impact on autonomy and quality of life. Many conservative treatments are available to improve bowel management; however, in case of failure, a colostomy may be considered. SETTING: Specialized Care Unit, Montecatone Rehabilitation Institute and General Surgery Division, Imola Hospital, Imola, Italy. METHODS: From 2016 to 2019, selected patients affected by SCI and bowel dysfunction failing conservative care were treated with subtotal colectomy associated with placement of a bioabsorbable prosthesis, to prevent parastomal hernia. The surgical procedure is presented along with results. RESULTS: Overall, 19 individuals underwent the described procedure; after 1 year of follow-up, we observed four minor complications: two cases of dehiscence of the abdominal incision, easily treated during hospital stay, and two cases of leakage of mucorrhoea. CONCLUSION: Our results demonstrate the efficacy of the procedure to improve bowel management in persons with spinal cord injury.

Orofacial pain induced by Eagle syndrome in an elderly patient with temporomandibular disorders - a case report.

BACKGROUND: Eagle syndrome (ES) is a rare disorder that can be responsible for orofacial pain. OBJECTIVE: To describe the treatment of an elderly patient affected by ES and temporomandibular disorders (TMD). MATERIALS AND METHODS: A patient complained of constant pain of the right temporomandibular joint (TMJ) and of the sensation of having a foreign body in the throat. Based on the patient's medical history and symptoms, a TMJs internal derangement and concomitant ES were suspected. A magnetic resonance and a computerised tomography confirmed the clinical diagnosis. A conservative treatment was initially performed to re-establish a functional occlusion. RESULTS: The rehabilitative treatment alleviated the pain almost totally. A slight residual uncomfortable sensation of the presence of a foreign body in the throat persisted after the oral rehabilitation but without any influence on the quality of life. CONCLUSION: In elderly patients complaining a chronic orofacial pain, the possibility of a concomitant TMD and ES has to be considered to correctly identify the source of pain. A conservative approach to identify weather TMD is the main source of pain is preferable, avoiding unnecessary invasive treatments.

A Luetic Cauda Equina Meningoradiculitis Mimicking a Central Nervous System Lymphoma.

We report a case of peculiar neurosyphilis, initially misinterpreted as a lymphoproliferative disorder. This is also the first report to evaluate the utility of positron emission tomography-computed tomography in spinal cord syphilis. Cauda equina radiculitis is a rare manifestation of neurosyphilis whose diagnosis can be supported by the typical syphilitic exanthema.

Surgical and Pathological Changes after Radiofrequency Ablation of Thyroid Nodules.

Background. Radiofrequency ablation (RFA) has been recently advocated as an effective technique for the treatment of symptomatic benign thyroid nodules. It is not known to what extent it may affect any subsequent thyroid surgery and/or histological diagnosis. Materials and Methods. RFA was performed on 64 symptomatic Thy2 nodules (benign nodules) and 6 symptomatic Thy3 nodules (follicular lesions/follicular neoplasms). Two Thy3 nodules regrew after the procedure, and these patients accepted to undergo a total thyroidectomy. Here we present how RFA has affected the operation and the final pathological features of the surgically removed nodules. Results and Conclusions. RFA is effective for the treatment of Thy2 nodules, but it should not be recommended as first-line therapy for the treatment of Thy3 nodules (irrespective of their mutational status), as it delays surgery in case of malignancy. Moreover, it is unknown whether RFA might promote residual tumor progression or neoplastic progression of Thy3 lesions. Nevertheless, here we show for the first time that one session of RFA does not affect subsequent thyroid surgery and/or histological diagnosis.

Classification of impacted mandibular third molars on cone-beam CT images.

BACKGROUND: Neurological involvement is a serious complication associated to the surgical removal of impacted mandibular third molars and the radiological investigation is the first mandatory step to assess the risk of a possible post-operative injury to the inferior alveolar nerve (IAN). The aim of this study was to introduce a new radiological classification that could be normally used in clinical practice to assess the relationship between an impacted third molar and mandibular canal on cone beam CT (CBCT) images. MATERIAL AND METHODS: CBCT images of 80 patients (133 mandibular third molars) were independently studied by three members of the surgical team to draw a classification that could describe all the possible relationships between third molar and IAN on the cross-sectional images. Subsequently, the study population was subdivided according to this classification. The SPSS software, version 15.0 (SPSS® Inc., Chicago, Illinois, USA) was used for the statistical analysis. RESULTS: Eight different classes were proposed (classes 0-7) and six of them (classes 1-6) were subdivided in two subtypes (subtypes A-B). The distribution of classes showed a prevalence of buccal or apical course of the mandibular canal followed by lingual position and inter-radicular one. No differences have resulted in terms of anatomic relationship between males and females apart from a higher risk of real contact without corticalization of the canal when the IAN had a lingual course for female group. Younger patients showed an increased rate of direct contact with a reduced calibre of the canal and/or without corticalization. CONCLUSIONS: The use of this classification could be a valid support in clinical practice to obtain a common language among operators in order to define the possible relationships between an impacted third molar and the mandibular canal on CBCT images. Key words:CBCT, classification, inferior alveolar nerve, third molars.

Radiofrequency ablation compared to surgery for the treatment of benign thyroid nodules.

Objective. Benign thyroid nodules are a common occurrence whose only remedy, in case of symptoms, has always been surgery until the advent of new techniques, such as radiofrequency ablation (RFA). This study aimed at evaluating RFA efficacy, tolerability, and costs and comparing them to hemithyroidectomy for the treatment of benign thyroid nodules. Design and Methods. 37 patients who underwent RFA were retrospectively compared to 74 patients surgically treated, either in a standard inpatient or in a short-stay surgical regimen. Efficacy, tolerability, and costs were compared. The contribution of final pathology was also taken into account. Results. RFA reduced nodular volume by 70% after 12 months and it was an effective method for treating nodule-related clinical problems, but it was not as effective as surgery for the treatment of hot nodules. RFA and surgery were both safe, although RFA had less complications and pain was rare. RFA costed €1,661.50, surgery costed €4,556.30, and short-stay surgery costed €4,139.40 per patient. RFA, however, did not allow for any pathologic analysis of the nodules, which, in 6 patients who had undergone surgery (8%), revealed that the nodules harboured malignant cells. Conclusions. RFA might transform our approach to benign thyroid nodules.

Rapidly progressing subperiosteal orbital abscess: an unexpected complication of a group-A streptococcal pharyngitis in a healthy young patient.

INTRODUCTION: Complications associated to group-A streptococcal pharyingitis include non-suppurative complications such as acute rheumatic fever and glomerulonephritis and suppurative complications such as peritonsillar or retropharyngeal abscess, sinusitis, mastoiditis, otitis media, meningitis, brain abscess, or thrombosis of the intracranial venous sinuses. CASE PRESENTATION: We described a case of a 15-year-old patient with a history of acute pharyngodinia early followed by improvise fever and a progressive formation of a diffuse orbital edema, corneal hyperaemia, diplopia and severe decrease of visual acuity.The patient was surgically treated with functional endoscopic sinus surgery (FESS) after the response of a maxillofacial computed tomography scans that showed a pansinusitis complicated by a left orbital cellulites. Numerous colonies of Streptococcus pyogenes were found in the samples of pus and an antibiotic therapy with meropenem was initiated on the basis of the sensitivity test to antibiotics. The patient was finally discharged with diagnosis of left orbital cellulites with periorbital abscess, endophtalmitis and acute pansinusitis as a consequence of streptococcal pharyngitis. CONCLUSION: The case highlights the possible unusual complication of a group-A streptococcal pharyingitis in a immunocompetent child and the needing of a prompt surgical and medical approach toward the maxillofacial complications associated to the infection.

Sigmoid compliance and visceral perception in spinal cord injury patients.

Intestinal motor and sensory dysfunctions in traumatic complete or incomplete spinal cord injury (SCI) are frequent and result in altered mechanisms of defecation. The aim of this study is to investigate sigmoid compliance and perception in chronic SCI patients. Sigmoid responses to fixed-tension distentions were assessed using a tensostat in six patients (six men, 42 ± 4 years) with chronic complete transection of the spinal cord (high-SCI; five tetraplegic C5-C7 and one paraplegic T4-T6) and impaired evacuation (i.e. constipation). A group of 10 healthy individuals (six men, 25 ± 1 years) served as controls. SCI patients had higher sigmoid compliance at the highest distention level than the controls (10.3 ± 2.4 vs. 5.1 ± 0.8 ml/mmHg; P<0.05). Perception scores at first sensation were higher in SCI patients (2.3 ± 0.7 vs. 1.1 ± 0.1; P<0.05), but were not different at the highest distention levels (3.7 ± 0.8 vs. 3 ± 1; NS). The most commonly reported sensation by patients was distention/bloating and was referred less commonly to the hypogastrium compared with distention/bloating in controls. An increased sigmoid compliance can be detected in constipated SCI patients. The preservation of some degree of visceral sensations, although abnormally referred, could imply the occurrence of sensory input remodeling at the spinal level.

Liver contrast enhanced ultrasound perfusion imaging in the evaluation of chronic hepatitis C fibrosis: preliminary results.

We wanted to determine whether liver contrast-enhanced ultrasound (CEUS)-derived peak signal intensity (PSI) and peak signal intensity/time (PIT) predict liver fibrosis in chronic hepatitis C (CHC). Forty-nine patients with CHC (METAVIR classification) and 10 control subjects were included in the study. After a bolus of 2.4 mL SonoVue (Bracco Imaging, Milan, Italy) solution was injected into a peripheral vein, the right lobe of the liver containing the right portal vein was scanned in a transverse section. Two-dimensional sonography was performed using the Philips iU22 ultrasound system (Philips Healthcare, Best, the Netherlands). A 1.0-5.0-MHz (C5-1) wideband convex transducer was used, applying the following settings in all cases. Regions of interest were manually drawn over the right liver lobe and over the portal vein (PV). Liver parenchyma PSI (LPpsi) and PIT (LPpit), portal vein PSI (PVpsi) and PIT (PVpit) were automatically calculated. δPSI was defined as the difference between PVpsi and LPpsi. A significant correlation was observed between PA(PSI) and fibrosis scores. When patients were stratified according to their LPpsi, a significant difference was achieved only between patients with fibrosis score 0-1 vs. 2-3 and 2 vs. 4. Statistically significant differences between all fibrosis scores, except 0 vs. 1 and 3 vs. 4 were observed when δPSI was used to stratify patients. Overall diagnostic accuracy of LPpsi and δPSI measurement for severe fibrosis by area under the receiving operator characteristic curve analysis was, respectively, 0.87 and 0.88. We suggest that liver CEUS perfusion could have the potential to be used as a complementary tool for the evaluation of liver fibrosis. However, further large-scale studies are required to accurately assess its accuracy in the evaluation of liver fibrosis.

New type of asymptomatic congenital portosystemic shunt.

Congenital extrahepatic portosystemic shunt (CEPS) is an extremely rare anomaly. In these malformations splanchnic blood bypasses the liver and drains into the systemic circulation through the inferior vena cava (IVC) or the left renal vein (LRV). Extrahepatic shunts may be divided into type 1 [end-to-side mesenterico-caval fistula with congenital absence of the portal vein (PV)] and type 2 (partial portocaval shunt caused by side-to-side mesenterico-caval fistula with normal or hypoplasic PV). Type 2 shunts typically are wholly extrahepatic between the PV or its right branch and the retrohepatic IVC. This report describes an asymptomatic case of CEPS not previously documented and not classifiable as type 1 or 2. CT revealed a normal PV with communication between the inferior mesenteric vein (IMV) and the LRV. The inferior mesenteric vein appeared tortuous, abnormally long and with a large calibre, and presented a connection with the LRV, in addition to a normal confluence into the splenic vein. Colour Doppler revealed hepatopetal normal flow in the PV and superior mesenteric vein with mild portal hypertension and an inversion of flow in the IMV directed to the LRV. Biochemical parameters showed a normal liver function without hyperammonaemia.

Gallbladder agenesis and cystic duct absence in an adult patient diagnosed by magnetic resonance cholangiography: report of a case and review of the literature.

Gallbladder agenesis (GA) is a rare congenital anomaly of the biliary system often associated with other congenital abnormalities. Patients become symptomatic in 23% of cases. GA is often misinterpreted as other diseases, therefore, leading to unnecessary surgery. We report a case of congenital GA associated to cystic duct absence and a biliary tract abnormality diagnosed by Magnetic Resonance with Cholangiopancreatography.

Outcome of transanal irrigation for bowel dysfunction in patients with spinal cord injury.

BACKGROUND/OBJECTIVE: To compare symptoms of neurogenic bowel dysfunction in patients with spinal cord injury (SCI) at baseline and after 10 weeks of treatment with transanal irrigation and to identify possible factors that could predict outcome of the treatment. METHODS: Sixty-two patients with SCI (45 men and 17 women; mean age, 47.5 +/- 15.5 [SD] years) from 5 specialized European SCI centers were offered treatment with transanal irrigation for a 10-week period. Bowel function was assessed at baseline and at termination using the Cleveland Clinic Constipation Scoring System (CCCSS; 0-30, 30 = severe symptoms), St. Mark's Fecal Incontinence Grading System (FIGS; 0-24, 24 = severe symptoms), and the Neurogenic Bowel Dysfunction score (NBD; 0-47, 47 severe symptoms). Factors predicting improvement in bowel function scores were identified using a general linear model. RESULTS: Severity of symptoms at termination was significantly reduced compared with baseline values (CCCSS: -3.4; 95% confidence interval [CI], -4.6 to -2.2; FIGS: - 4.1; 95% CI, -5.2 to -2.9; NBD: -4.5; 95% CI, -6.6 to -2.4; all P < 0.0001). Although several factors were associated with positive outcome, no consistent and readily explainable pattern could be identified. Surprisingly, hand function, level of dependency, predominant symptom, and colonic transit time were not associated with outcome. CONCLUSIONS: Transanal irrigation in patients with SCI reduces constipation, improves anal continence, and improves symptom-related quality of life. No readily obtainable factors could predict outcome, which might be because of the relatively low number of patients. This supports the use of trial and error as a strategy in deciding on a bowel management method for neurogenic bowel dysfunction.

Percutaneous cryoablation of small hepatocellular carcinoma with US guidance and CT monitoring: initial experience.

The purpose of this study was to retrospectively determine the safety and effectiveness of percutaneous cryoablation, monitored with computed tomography (CT) and ultrasonographic (US) guidance, for the treatment of hepatocellular carcinoma (HCC). Four patients with small HCCs underwent one percutaneous cryoablation treatment session monitored with CT and US guidance. All patients underwent pretreatment blood chemistry testing and imaging evaluation. We treated lesions with simultaneous insertion of multiple 17-G cryoprobes (two or three) and defined technical success when the extension of a visible iceball was beyond 5 mm from the tumor margin. Intralesional enhancement or tumoral size increase was defined as local progression compared with that on images obtained immediately after ablation. We evaluated complications and follow-up (at 1, 3, and 6 months). All patients survived without short- or long-term complications. Cryoablation was technically successful in all patients at the end of the procedure. During follow-up two patients developed disease recurrence. One patient developed local tumor progression on the margin of the lesion; the other, a new HCC. In the case of local tumor progression a new elevation of alpha-fetoprotein (alphaFP) levels occurred at first follow-up control. In the other case levels of alphaFP remained stable during the first 3 months after the procedure, then demonstrated a progressive increase in alphaFP levels beginning at the fourth month, without tumor evidence during CT control at 3 months. We conclude that percutaneous cryotherapy with US guidance and CT monitoring is a feasible, safe, and effective for treatment of HCC. If local ablative procedures of hepatic lesions are to be performed, percutaneous cryoablation, not laparotomic, should be discussed as an alternative therapeutic measure. Longer follow-up should provide proof of the effectiveness of this technique.

A randomized, controlled trial of transanal irrigation versus conservative bowel management in spinal cord-injured patients.

BACKGROUND & AIMS: Bowel dysfunction in patients with spinal cord injury often causes constipation, fecal incontinence, or a combination of both with a significant impact on quality of life. Transanal irrigation improves bowel function in selected patients. However, controlled trials of different bowel management regimens are lacking. The aim of the present study was to compare transanal irrigation with conservative bowel management (best supportive bowel care without irrigation). METHODS: In a prospective, randomized, controlled, multicenter trial involving 5 specialized European spinal cord injury centers, 87 patients with spinal cord injury with neurogenic bowel dysfunction were randomly assigned to either transanal irrigation (42 patients) or conservative bowel management (45 patients) for a 10-week trial period. RESULTS: Comparing transanal irrigation with conservative bowel management at termination of the study, the mean (SD) scores were as follows: Cleveland Clinic constipation scoring system (range, 0-30, 30 = severe symptoms) was 10.3 (4.4) versus 13.2 (3.4) (P = .0016), St. Mark's fecal incontinence grading system (range, 0-24, 24 = severe symptoms) was 5.0 (4.6) versus 7.3 (4.0) (P = .015), and the Neurogenic Bowel Dysfunction Score (range, 0-47, 47 = severe symptoms) was 10.4 (6.8) versus 13.3 (6.4) (P = .048). The modified American Society of Colorectal Surgeon fecal incontinence scores (for each subscale, range is 0-4, 4 = high quality of life) were: lifestyle 3.0 (0.7) versus 2.8 (0.8) (P = .13), coping/behavior 2.8 (0.8) versus 2.4 (0.7) (P = .013), depression/self perception 3.0 (0.8) versus 2.7 (0.8) (P = .055), and embarrassment 3.2 (0.8) versus 2.8 (0.9) (P = .024). CONCLUSIONS: Compared with conservative bowel management, transanal irrigation improves constipation, fecal incontinence, and symptom-related quality of life.