An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer.

OBJECTIVES: This study aimed to investigate G17DT, an immunogen producing neutralizing antibodies against the tumor growth factors amidated and glycine-extended forms of gastrin-17, in the treatment of pancreatic cancer. METHODS: A randomized, double-blind, placebo-controlled, group-sequential multicenter trial of G17DT in patients with advanced pancreatic cancer unsuitable for or unwilling to take chemotherapy. Inclusion criteria were a Karnofsky performance score of 60 or higher and a life expectancy of more than 2 months. Patients received G17DT or placebo emulsion at weeks 0, 1, 3, 24, and 52. The primary end point was survival, and secondary end points were tolerability, Karnofsky performance. RESULTS: A total of 154 patients were recruited: 79 G17DT and 75 placebo. A final analysis of the intention-to-treat population, using a proportional hazards model, stratifying by disease stage and adjusting for interim analysis, gave a hazard ratio for mortality of 0.75 (95% confidence interval, 0.51-1.10, P = 0.138; G17DT/placebo). A conventional analysis without adjustment for disease stage or interim analysis, censoring for chemotherapy and excluding protocol violators, gave median survival periods of 151 (G17DT) and 82 days (placebo) (log-rank test, P = 0.03).Patients developing anti-G17DT responses (73.8%) survived longer than nonresponders or those on placebo (median survival, 176 vs 63 vs 83; log-rank test, P = 0.003). G17DT was well tolerated.

[Nasojejunal tube positioning with fluoroscopic guidance]. / Nasojejunalis tápszonda-levezetés röntgenkép-erosíto segítségével.

The indication circle of enteral nutrition is continuously enlarging. Looking after this increasing group of patients, is now an everyday practice. Enteral nutrition has more advantages than intravenous. Amongst this, jejunal feeding is most widely applied, but it requires nasojejunal tube. Positioning the tube is possible by the guide of X-ray, endoscope, ultrasound, or simply "blind". Authors present the fluoroscopic technique, as their everyday practice. It does not demand special expertise, skilled endoscopist, or premedication, and can be performed in any hospital. It is fast, cheap, and tolerable. It's disadvantages are that only conscious, cooperating, spontaneously breathing patients can be treated such, and it involves irradiation. Authors have used this method 34 times in the past 3 years and had no major complications. Every patient suffered acute necrotising pancreatitis. Considering cost-benefit principles, they recommend this procedure as safe for all levels of in-patient departments.

[Selective bowel decontamination]. / A szelektív béldekontamináció.

Infective complications play major role in mortality of high risk patients demanding intensive care. Selective Bowel Decontamination prevents endogenous infections by reducing the number of potentially pathogen microbes (aerobic bacteria, fungi) in the oropharynx and gastrointestinal tract, saving anaerobic bacteria. It had been used 20 years ago for the first time. Authors survey it's literature ever since. Selective Bowel Decontamination is performed by the mixture of antibiotics and antimycotic drug, administered orally in hydrogel, and suspension form in nasojejunal tube. The number of Gram negative optional aerobic bacteria and fungi decrease significantly in the gut, and the microbial translocation is following this tendency. Foreign authors achieved good results in acute necrotizing pancreatitis, after liver transplant, in polytrauma, in serious burn and in haematological malignancies. According to the literature Selective Bowel Decontamination shows advantages in selected groups of high risk surgical patients. In some studies the administration took few months, but the minimum time was one week. There was no report of increasing MRSA appearance. Regular bacteriological sampling is highly recommended in order to recognize any new antibiotic resistance in time.

[The first clinical experiences in Hungary with a new effective antibiotic (linezolid) effective against Gram-positive infections]. / Multirezisztens Gram-pozitív kórokozók ellen hatékony, új antibiotikummal (linezolid) szerzett elsó magyarországi tapasztalatok.

INTRODUCTION: The occurrence of gram-positive infections caused by multiresistant organisms has increased significantly in general, particularly among the surgical patients, and only a few effective antibiotics are available. A new and effective, synthetic antibiotic, against gram-positives is the oxazolidinon group, that electively inhibits bacterial protein synthesis in the early phase. Linezolid, the first member of this group to be used in clinical practice is the linezolid was studied. AIMS: The purpose of this study was to evaluate the effectiveness and safety of linezolid in the gram-positive infections of surgical patients. METHODS: A 3rd phase, clinical trial was conducted at the Semmelweis University Ist Surgical Department in the period of 1999-2001. Twenty-one patients with gram-positive infections were enrolled to this study. The mean of age was 57 years. Patients were selected for linezolid treatment in whom the conventional anti-gram-positive antibiotic therapy caused difficulties. RESULTS: Sixteen patients out of 21 recovered, one patient was cured clinically, but not microbiologically, and one case showed microbiological cure with clinical failure. In one case the methicillin resistant Staphylococcus aureus carriership was cured. Two cases had a fatal outcome. The causes of death were mediastinitis plus pneumonia in one case, and diffuse peritonitis with renal insufficiency in the other. Withdrawal from the study occurred in one case, due to drug intolerance. CONCLUSIONS: The linezolid administration proved to be safe and effective even in those cases, in which either hypacusis or decreased renal function persisted, or oral intake was advantagous. Contraindication of linezolid therapy did not occur. Few side effects were observed. If the infection was polymicrobial, the linezolid could be combined with other antibiotics. Further investigations are mandatory to evaluate the role of linezolid in the treatment of methicillin resistant Staphylococcus aureus carriership.

Streptococcus pneumoniae as an etiologic agent in infectious complications of pancreatic disease.

Systematic culturing of perioperative intra-abdominal samples allowed us to recognize the presence of Streptococcus pneumoniae in infectious complications of chronic pancreatitis in 9 male patients. In 8 of 10 of the intra- or peripancreatic samples, S. pneumoniae was the single isolate identified. All but one of the S. pneumoniae isolates were sensitive to penicillin. The patients had predisposing underlying conditions such as alcoholism and diabetes mellitus. All patients were cured due to adequate surgery and antibiotic treatment. Analysis of the case histories suggests that S. pneumoniae may have been a relevant organism causing the infectious complications of pancreatitis in these patients.

[Chronic pancreatitis combined with obliterative arterial disease]. / Chronicus pancreatitis és obliteratív veróérbetegég együttes elófordulása.

We performed a prospective study at the 1st Surgical Department, Semmelweis University Budapest between 1996 and 2000, in which we examined the common occurrence of chronic pancreatitis and obstructive vascular disease in patients admitted to our department because of either of these illnesses. There were 37 patients suffering from both diseases, all are included in our trial. Control groups were set up of 50 consecutive chronic pancreatitis patients and 50 consecutive vascular patients. In all patients with two disease chronic pancreatitis developed earlier than vascular disease. Occurrence of vascular disease is twice as common among patients with chronic pancreatitis as in normal population. Risk factors like smoking, coffee-abuse and alcohol, which might trigger both diseases, didn't vary in the three groups. This combination of diseases usually starts in the young, and causes severe and progressive deterioration in the quality of life. In four patients after operations performed because of chronic pancreatitis, peripheral arterial operation was also necessary. Operative mortality rate in the chronic pancreatitis group was 2%, in vascular patients 4% and in the group with both diseases it was 16%. We found in our study that there is relation between chronic pancreatitis and peripheral obstructive vascular disease. Further examinations are necessary to examine the etiology. In patients with chronic pancreatitis we must always think of the possibility of later obstructive vascular disease.