Primary Open Versus Closed Implantation Strategy for Totally Implantable Venous Access Ports: The Multicentre Randomized Controlled PORTAS-3 Trial (DRKS 00004900).

OBJECTIVES: PORTAS-3 was designed to compare the frequency of pneumothorax or haemothorax in a primary open versus closed strategy for port implantation. BACKGROUND DATA: The implantation strategy for totally implantable venous access ports with the optimal benefit/risk ratio remains unclear. METHODS: PORTAS-3 was a multicentre, randomized, controlled, parallel-group superiority trial. Adult patients with oncological disease scheduled for elective port implantation were randomized to a primary open or closed strategy. Primary endpoint was the rate of pneumothorax or haemothorax. Assuming a difference of 2.5% between the 2 groups, a sample size of 1154 patients was needed to prove superiority of the open group. A logistic regression model after the intention-to-treat principle was applied for analysis of the primary endpoint. RESULTS: Between November 9, 2014 and September 5, 2016, 1205 patients were randomized. Of these, 1159 (open n = 583; closed n = 576) were finally analyzed. The rate of pneumothorax or haemothorax was significantly reduced with the open strategy [odds ratio 0.27, 95% confidence interval (CI) 0.09-0.88; P = 0.029]. Operation time was shorter for the closed strategy. Primary success rates, tolerability, morbidity, dose rate of radiation, and 30-day mortality did not differ significantly between the groups. CONCLUSION: A primary open strategy by cut-down of the cephalic vein, if necessary enhanced by a modified Seldinger technique, reduces the frequency of pneumothorax or haemothorax after central venous port implantation significantly compared with a closed strategy by primary puncture of the subclavian vein without routine sonographic guidance. Therefore, open surgical cut-down should be the reference standard for port implantation in comparable cohorts. TRIAL REGISTRATION: German Clinical Trials Register DRKS 00004900.

[Prognostic role of vascularisation and proliferation in rectal cancer with liver metastasis]. / A vascularisatio és a proliferatio prognosztikai szerepe májmetastasist adó rectumcarcinomákban.

BACKGROUND: The present study was designed to provide an analysis of factors for angiogenesis and proliferation. MATERIAL AND METHOD: We analyzed tumor tissues from 37 rectal cancer patients with concurrent or subsequent liver metastasis underwent preoperative radiotherapy, surgery and adjuvant chemotherapy. Immunohistochemistry was used for expression of proliferation (staining with anti-Ki67: MIB-1) and for detection of microvessel density (MVD, expressed by CD34). Clinicopathological findings were compared with outcome with emphasis to IHC. RESULTS: A vascular enumeration and pN status and the time of presence of the metastases has shown prognostic role along with the factors above. Increased proliferative activity of the tumor as expressed by MIB-1 staining has no prognostic value, similarly to the localization of tumor, gender, age or grading. SUMMARY: Different prognostic and predictive factors in colorectal cancer have been reported. Higher pN status and tumor vascularisation has been linked to poor prognosis in overall survival and tumor recurrence.

Possible role of human papilloma virus infection in response to neoadjuvant therapy in patients with esophageal cancer.

BACKGROUND/AIMS: Human papilloma virus (HPV) infection in esophageal cancer cases has been found in 0-70%, depending on different methods and geographical variances. Complete pathological response has been found in 30% of cases after neoadjuvant chemo-radiation (CRX). The aim of this study was to discover a possible relation between HPV-infection and response. METHODOLOGY: DNA was obtained from 26 esophageal cancer patients undergoing CRX and surgery. Polymerase chain reaction (PCR) and Southern Blot hybridization was used to detect HPV-infection (HPV-16 and -18). Clinicopathological parameters, disease-free survival and overall survival were also analyzed. RESULTS: Complete response (26.9%) and partial response (38.5%) after CRX was correlated significantly with better prognosis. Six patients had HPV-infection (3 from the CR- and 3 from PR-group). CONCLUSIONS: There was correlation between HPV-infection and response, but further analyses are necessary. Both responder-groups had a significantly better prognosis than non-responders.

[HPV-infection in esophageal cancer as possible predictive factor after neoadjuvant therapy]. / A HPV-infekció lehetséges prediktív szerepe nyelocsorakos betegek neoadjuváns terápiára adott remissziójában.

BACKGROUND: Human papilloma virus (HPV) infection in oesophageal cancer cases was found 0-67% depending on different methods and geographical variances. Complete pathological response was in 30% of cases after neoadjuvant chemo-radiation (CRX). The aim of this study was to discover a possible relation between HPV-infection and response. MATERIAL AND METHODS: DNA was extracted from 26 oesophageal cancer patients undergoing CRX and surgery. PCR and Southern Blot hybridisation was used to detect HPV-infection (HPV-16 and -18). Clinicopathological parameters and disease-free survival and overall survival was also analysed. RESULTS: Complete response (26.9%) and partial response (38.5%) after CRX was correlated significantly with better prognosis. 6 patient had HPV-infection (3 from CR- and 3 from PR-group). CONCLUSIONS: There was a correlation between HPV-infection and response, but further analysis is necessary. Both responder-groups had significantly better prognosis than non-responders.

[Predictive factors in esophageal cancer after neoadjuvant therapy]. / Neoadjuváns terápián átesett nyelocso-rákos betegek prediktív faktorai.

BACKGROUND: Preoperative chemoradiation therapy (PCX) was introduced to improve the outcome of patients with oesophageal cancer (EC), but conflicting results have been released. Some 20-30% of patients show a complete pathological response, however, the perioperative morbidity and mortality is increased. To search for factors indicating response prior to the onset of PCX we investigated the proliferative activity (MIB-1), the expression of vascular endothelial growth factor (VEGF), and the capillary density (CD34) tissue specimens of ECs were available by endoscopy prior to the start of the treatment. METHODS: Forty-six (MIB-1) and 21 (VEGF, CD34) tissue specimens of ECs were available from 56 patients undergoing pretherapeutic endoscopy, PCX and surgery. Perioperative morbidity was divided into surgery and non-surgery related morbidity. MIB-1, VEGF and CD34 expression were investigated immunohistochemically. Multivariate analysis was carried out to prove independence of investigated variables. RESULTS: Postoperative morbidity was noticed in 54 of 56 operated patents. Eight of 56 patients who received PCX died in hospital. Survival was significantly different between the group of complete responders (n=14) and non-responders (n=23; P = 0.0026). None of investigated tumour samples from patients with a complete response (CR) had a proliferation index of less than 45. Tumour samples from patients with a CR showed a VEGF expression of 10.7 compared with 36.58 of tumours with no response (P = 0.035). CD34 expression showed a correlation with VEGF expression. The relation of mean indices of VEGF expression and proliferative activity in tumours from patients with complete, partial or no response was 10. 7:58.8, 18.3:53.8 and 36.6:43.5, respectively. CONCLUSIONS: According to these results, it may be expected that tumours with a VEGF/MIB-1 ratio of 1:5 or less prior to PCX will respond to this therapy.

[Laparoscopic cholecystectomy is the current standard intervention]. / Wenn die Gallenblase raus muss. Offen ist out!

In the case of gallstone disease a differentiation is made between uncomplicated symptomatic cholecystolithiasis and acute cholecystitis. In either condition, differentiation may be rendered more complicated by the simultaneous presence of choledocholithiasis. Today, the standard intervention for the removal of the gallbladder is the laparoscopic modality. Early laparoscopic cholecystectomy is now the regular approach, since the former practice (antibiotic therapy and surgery in the inflammation-free interval) led to a considerable delay, which was often accompanied by massive intra-abdominal adhesions and which resulted in an increase in the conversion rate.

Impact of neoadjuvant therapy of perioperative morbidity in patients with esophageal cancer.

BACKGROUND: Conflicting results of preoperative radiochemotherapy in patients with esophageal cancer have been obtained; only patients with a complete pathological response seem to benefit from this therapy. However, there is evidence that preoperative radiochemotherapy leads to considerable postoperative morbidity. Therefore, postoperative morbidity was retrospectively investigated in 82 patients with an esophageal cancer who received preoperative radiochemotherapy. METHODS: One hundred twenty-two consecutively operated on patients were included (1991 to 2001). Preoperative radiochemotherapy was initiated in 1994 for cT >1, cNx, cM0 regardless of histology (n = 82); 36 Gy was applied (1.8 Gy daily, days 1 to 5, weeks 1 to 4), concurrently 5-fluorouracil (500 mg/m(2) days 1 to 5, weeks 1 to 4), and cisplatin (20 mg/m(2) days 1 to 5, weeks 1 and 4). Postoperative morbidity was categorized as surgery- and nonsurgery-related morbidity. Survival was calculated by the Kaplan-Meier method. Results were stratified into histology and compared with patients who were operated on only (n = 40). RESULTS: Complete pathological response after preoperative radiochemotherapy was achieved in 22%. An increase in surgery-related morbidity was observed after preoperative radiochemotherapy due to lesion of recurrent nerve (38% versus 12.5%, P = 0.009), as well as a marked difference in pulmonary morbidity (57% versus 37.5%, P = 0.05). The proportion of combined morbidity was increased after preoperative radiochemotherapy (49.4% versus 15%, P = 0.02), which led to a considerable prolongation of postoperative hospital stay (33 versus 21 days median, P = 0.0022). Patients with a longer postoperative hospital stay (>30 days; 43.2%) lived significantly shorter than patients with a shorter postoperative hospital stay (56.8%, P = 0.001). There was no statistical survival benefit in the neoadjuvant treated group. However, calculation of long-term survival revealed a significant survival advantage in patients with squamous cell cancer and a complete pathological response compared with patients without response (median 642 days versus 302, P = 0.026). CONCLUSIONS: Perioperative morbidity was significantly increased after preoperative radiochemotherapy. Long-term survival was clearly affected by the length of postoperative stay. Therefore, we need better patient selection for application of preoperative radiochemotherapy.