Totally Implantable Venous Access Devices: A Randomized Controlled Trial on the Effect of Psychological Support on Quality of Life and Body Image (BI-PORT).

Background: The presence of totally implantable venous access devices (TIVADs), as any permanent or semipermanent medical devices, has an impact on the quality of life (QoL) of patients. Therefore, the purpose of this trial was to evaluate the efficacy of psychological support for patients undergoing this procedure. Methods: This randomized controlled trial (RCT) aimed to compare the efficacy of a psychological intervention vs. standard care on QoL in patients receiving TIVAD for chemotherapy treatment (ClinicalTrials.gov NCT02075580). The trial was conducted at the Veneto Institute of Oncology IOV-IRCCS (Padua, Italy) between October 2013 and September 2018. Participants were neoplastic adults receiving TIVAD for chemotherapy treatment for any cancer, not undergoing visible demolitive interventions, without psychopathological diagnosis and language understanding. The exclusion criteria were patients without a diagnosis of cancer, with psychopathological diagnosis, or with language misunderstanding. Results: The variation of C30-QL2 and BR32-BI was not statistically different between intervention and control arms in men and women. However, the variation of C30-SF was statistically better in the intervention than control arm in men [mean difference (MD) 22.3, 95% CI 3.5 to 41.0] but not in women (MD -2.7, 95% CI -24.0 to 18.7). The variations of the other secondary outcome measures were not statistically different between intervention and control arms. Conclusion: Psychological support did not show any clear advantages on global QoL and body image perception in patients at 15 days after TIVAD insertion for chemotherapy. In contrast, male patients might benefit from even a very short psychological counseling before or during chemotherapy even if they do not seem to ask for it.

Case Report: Surgical Reconstruction of a Massive Thoracic Wall Defect After the Resection of an Undifferentiated Radiation-Induced Sarcoma of the Breast.

A 54-year-old lady was referred to our institute because of a massive thoracic neoplasm arising from the thoracic wall which infiltrated and dislocated the left breast. Twenty years before, the patient had undergone a quadrantectomy with axillary dissection for an infiltrating ductal carcinoma of the left breast, followed by adjuvant radiotherapy and chemotherapy. A true-cut biopsy of the mass showed a low differentiated malignant neoplasm with spindle-shaped cells. The patient underwent a total-body CT scan which showed a 16 × 15 × 10 cm largely necrotic mass with irregular and undefined margins, with little homolateral round-shaped cervical and mesenteric lymph nodes but no distant metastases. After a multidisciplinary discussion, we proposed surgery as the first therapeutic option. The planned treatment was a wide excision of the mass with the underlying ribs (II-VI) followed by the reconstruction of the thoracic wall using titanium bars covered by the acellular porcine dermis, latissimus dorsi flap, and finally, skin grafts from the thighs.

Ablation of soft tissue tumours by long needle variable electrode-geometry electrochemotherapy: final report from a single-arm, single-centre phase-2 study.

Standard electrochemotherapy (ECT) is effective in many tumour types but is confined to the treatment of small superficial lesions. Variable electrode-geometry ECT (VEG-ECT) may overcome these limitations by using long freely-placeable electrodes. Patients with bulky or deep-seated soft-tissue malignancies not amenable to resection participated in a single-arm phase-2 study (ISRCTN.11667954) and received a single course of VEG-ECT with intravenous bleomycin (15,000 IU/m2) and concomitant electric pulses applied through an adjustable electrode array. The primary outcome was radiologic complete response rate (CRR) per RECIST; secondary endpoints included feasibility, metabolic response, toxicity (CTCAE), local progression-free survival (LPFS) and patient perception (EQ-5D). During 2009-2014, we enrolled 30 patients with trunk/limb sarcomas, melanoma, Merkel-cell carcinoma, and colorectal/lung cancer. Median tumour size was 4.7 cm. Electrode probes were placed under US/TC guidance (28 and 2 patients, respectively). Median procedure duration was 80 minutes. Tumour coverage rate was 97% (29 of 30 patients). Perioperative side-effects were negligible; one patient experienced grade-3 ulceration and infection. One-month 18F-FDG-SUV decreased by 86%; CRR was 63% (95% CI 44-79%). Local control was durable in 24 of 30 patients (two-year LPFS, 62%). Patients reported an improvement in "usual activities", "anxiety/depression", and "overall health" scores. VEG-ECT demonstrated encouraging antitumour activity in soft-tissue malignancies; a single course of treatment produced high and durable responses, with low complications.

Electrochemotherapy of superficial tumors - Current status:: Basic principles, operating procedures, shared indications, and emerging applications.

Treatment of superficial tumors with electrochemotherapy (ECT) has shown a steep rise over the past decade and indications range from skin cancers to locally advanced or metastatic neoplasms. Based on reversible electroporation, which is a physical method to achieve transient tumor cell membrane permeabilization by means of short electric pulses, ECT increases cellular uptake of bleomycin and cisplatin and their cytotoxicity by 8,000- and 80-fold, respectively. Standard operating procedures were established in 2006 and updated in 2018. Ease of administration, patient tolerability, efficacy across histotypes, and repeatability are peculiar advantages, which make standard ECT (ie, ECT using fixed-geometry electrodes) a reliable option for controlling superficial tumor growth locally and preventing their morbidity. Consolidated indications include superficial metastatic melanoma, breast cancer, head and neck skin tumors, nonmelanoma skin cancers, and Kaposi sarcoma. In well-selected patients with oropharyngeal cancers, ECT ensures appreciable symptom control. Emerging applications include skin metastases from visceral or hematological malignancies, vulvar cancer, and some noncancerous skin lesions (keloids and capillary vascular malformations). Repeatability and integration with other oncologic therapies allow for consolidation of response and sustained tumor control. In this review, we present the basic principles of ECT, recently updated operating procedures, anesthesiological management, and provide a synthesis of the efficacy of standard ECT across histotypes.

Factors influencing challenging colonoscopies during anesthesiologist-assisted deep sedation.

BACKGROUND/AIM: Increased demand for colon cancer screening procedures can significantly impact on routine colonoscopy management at dedicated facilities, prompting a review of the factors that can negatively affect workflow. Although potential adverse effects and impact on costs of deep sedation have been documented elsewhere, this study focuses on variables that can influence performance of colonoscopy in deep sedation and interfere with normal procedure scheduling in settings where the presence of an anesthesiologist is mandatory. PATIENTS AND METHODS: We performed a cross-sectional study of the activities of a colonoscopy screening unit, applying Bayesian Network (BN) analysis, designed to assess interdependencies among variables that can affect a process in complex, multidimensional systems. The study was performed at a teaching hospital where endoscopists and anesthesiologists of varying work experience operate on a rota basis. During a six-month period, we analyzed 1485 consecutive colonoscopies performed under deep propofol sedation, administered by an anesthesiologist via hand-controlled syringe. The BN was constructed with the variables: Gender, age, ASA status, bowel preparation, baseline blood pressure, endoscopist's experience, anesthesiologist's experience, presence of polypectomy, and the target node, "challenging procedure." This previously undefined category refers to any events disrupting the scheduled rota. RESULT AND CONCLUSION: Two distinct networks were identified. One deals mainly with relationships among the variables, patients' demographic and clinical characteristics (procedures with polypectomy, ASA and baseline blood pressure). The other explains relationships among the variables, "challenging procedure," bowel preparation, and endoscopist's experience. The factors associated with the anesthesiologist's activity do not influence challenging colonoscopies.

Totally implantable venous access devices: retrospective analysis of different insertion techniques and predictors of complications in 796 devices implanted in a single institution.

BACKGROUND: The aim of this study was to assess the efficacy and safety of totally implanted vascular devices (TIVAD) using different techniques of insertion. METHODS: We performed a retrospective study using a prospective collected database of 796 consecutive oncological patients in which TIVADs were inserted. We focused on early and late complications following different insertion techniques (surgical cutdown, blind and ultrasound guided percutaneous) according to different techniques. RESULTS: Ultrasound guided technique was used in 646 cases, cephalic vein cutdown in 102 patients and percutaneous blind technique in 48 patients. The overall complication rate on insertion was 7.2% (57 of 796 cases). Early complications were less frequent using the ultrasound guided technique: arterial puncture (p = 0.009), technical failure (p = 0.009), access site change after first attempt (p = 0.002); pneumothorax occurred in 4 cases, all using the blind percutaneus technique. Late complications occurred in 49 cases (6.1%) which required TIVAD removal in 43 cases and included: sepsis (29 cases), thrombosis (3 cases), dislocation (7 cases), skin dehiscence (3 cases), and severe pain (1 case). CONCLUSION: Ultrasound guided technique is the safest option for TIVAD insertion, with the lowest rates of immediate complications.

A multidisciplinary approach to improve preoperative understanding and reduce anxiety: a randomised study.

BACKGROUND: Emotional factors may influence reception of information provided during informed consent leading to incomplete understanding and reduced satisfaction. OBJECTIVE: This study was designed to test the hypothesis that a multidisciplinary approach could improve understanding of the information provided by the anaesthesiologist and in turn, reduce anxiety. DESIGN: A randomised controlled clinical trial. SETTING: Veneto Oncology Institute, Italian comprehensive cancer centre. Recruitment from December 2008 to June 2010. PATIENTS: Two hundred and fifty-one women requiring anaesthesia for breast cancer surgery. INTERVENTIONS: Women undergoing surgery for primary breast cancer were randomly assigned to either the structured anaesthesiology interview group (SAI) or the integrated multidisciplinary psycho-oncological approach (IPA). In the IPA arm, patients underwent an interview with the psycho-oncologist. Subsequently, and prior to preoperative anaesthesia evaluation, the psycho-oncologist informed the anaesthesiologist of the type of communicative strategy to adopt for each individual. In the SAI arm, patients received only the anaesthesiology interview. MAIN OUTCOME MEASURES: Anxiety as assessed by State-Trait Anxiety Inventory (STAI) questionnaire. RESULTS: Two hundred and fifty-one patients were randomised and 234 analysed: 124 in the IPA arm and 110 in the SAI arm. For both groups, mean anxiety scores, according to the STAI questionnaire, were statistically lower after the anaesthesiology visit than at baseline, with a reduction of 6.5 points for the IPA arm [95% confidence interval (CI) 4.6 to 8.4, P < 0.0001] and 4.7 points for the SAI arm (95% CI 2.6 to 6.7, P < 0.0001). There were no significant differences between the two groups in the mean anxiety score before and after the interview. For highly anxious patients, the STAI score decreased significantly more in the IPA group (10.2 points, 95% CI 7.4 to 13.0) than in the SAI group (6.8 points, 95% CI 3.8 to 9.8), P = 0.024.The information provided during the anaesthesiology visit was correctly understood by more than 80% of patients and was similar in both groups. CONCLUSION: In breast cancer surgical patients with high levels of preoperative anxiety, a multidisciplinary approach with psycho-oncological intervention proved to be useful at the preoperative anaesthesiology interview.