Symptomatic Ascites Research Articles

Peritoneal catheter for continuous drainage of ascites in advanced cancer patients

Advanced cancer patients with refractory ascites do not often respond to dietary sodium restriction and diuretics. While paracentesis is effective, the condition invariably recurs, necessitating repeated procedures. A continuous peritoneal drainage by an indwelling catheter has been reported to be hugely beneficial symptomatically, avoiding the hazards and disadvantages of multiple repeated procedures and direct and indirect costs. Forty patients with advanced cancer patients admitted to an acute pain relief and palliative care unit, who presented symptomatic ascites, were recruited for continuous drainage of peritoneal fluid. A central venous catheter set for Seldinger technique was used. Technical failure was defined as an unsuccessful drainage of fluid through the catheter. Immediate and late complications, including hypotension, haemorrhage, tube blockage, dislodgment and sepsis were recorded. Record of daily drainage during admission were noted. At time of discharge, patients were asked to rate their global symptom burden as improved, unchanged or worsened. The follow-up was performed with frequent phone contacts or day-hospital admission in case of problems. The mean patients' age was 68 years, and 21 were men. Patients were receiving unsuccessfully a mean dose of furosemide of 32 mg/day. The technique was not painful and was easily accepted by patients. Insertion was technically successful in almost all patients. Mean admission time was 5.5 days (range 2-14), and the mean drained volume during admission was 8,499 ml (range 800-20,700), 2,850 ml (300-4,200) being drained on the first 24 h. No immediate complications were recorded. Six patients died during admission. The mean survival was 38.9 days (range 1-120). Of the 34 patients who were discharged home, 22 patients stated that symptom burden had improved, while in 10 patients symptom burden did not change or worsened, probably due to the advanced status of diseases and multiple contributing factors. Five, two, and one patients required skin sutures at 1, 2 and 3 months, respectively. About one third of patients had mechanical problems, some of them requiring a catheter replacement. No infection was recorded. In conclusion, a permanent peritoneal catheter was a valuable method to remove abdominal fluids and reduce symptom burden attributable to ascites and was also easy to use at home. Complication rate was acceptable and balanced by the benefits of the technique which avoided frequent paracentesis and associated complications.

Treatment of ovarian cancer patients with malignant ascites using the trifunctional antibody catumaxomab: Results of a phase II/III study

5520 Background: Malignant ascites in ovarian carcinoma patients (pts.) is associated with a poor prognosis and reduced quality of life. Catumaxomab (anti-EpCAM × anti-CD3) is known to effectively eliminate tumor cells within ascites by simultaneously activating T cells and Fc gamma-receptor positive cells and redirecting them against the tumor. Methods: A total of 129 ovarian cancer pts. with recurrent symptomatic malignant ascites containing EpCAM+ tumor cells were enrolled in the study; 85 were randomized to treatment with catumaxomab (paracentesis plus intraperitoneal infusions of 10, 20, 50 and 150 μg for 11 days), and 44 to the control arm (paracentesis alone). The primary endpoint was puncture free survival (time to first need for paracentesis after treatment or time to death, which ever occurred first). Results: Pts. characteristics were well balanced in both arms. Median puncture free survival was 52 days for catumaxomab vs. 11 days for control (p<0.0001) whereas the median time to first need for paracentesis was 71 days vs. 11 days l (p<0.0001). There was a pronounced decrease of tumor cell load accompanied by a distinct increase of leukocyte count during catumaxomab treatment within the ascites fluid. Overall and progression free survival data suggest longer survival for catumaxomab-treated pts. compared to control. Follow-up data will be presented. The most frequent AEs were symptoms related to cytokine release (pyrexia, nausea, vomiting). These were generally mild to moderate in intensity, and fully reversible. Transient increases in liver enzymes and bilirubin, and transient WBC abnormalities such as leukocytosis, neutrophilia and a decrease in peripheral lymphocyte were regularly observed as abnormal laboratory values but rarely considered clinically significant. Conclusions: Intraperitoneal therapy with catumaxomab resulted in a significant and clinically relevant improvement of puncture-free survival time, tumor cell load, and time to first need for puncture compared to the control group of best available treatment. The safety profile reflects catumaxomabs mode of action and reveals a low and acceptable toxicity. No significant financial relationships to disclose.

Immunomonitoring results of a pivotal phase II/III study with the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) in ovarian cancer patients with malignant ascites

3020 Background: Malignant ascites is a symptom of late-stage tumor disease and associated with a poor prognosis. The trifunctional antibody catumaxomab specifically binds to EpCAM+ tumor cells and redirects CD3+ T lymphocytes and FcγR I/III+ accessory cells simultaneously to the tumor site. Methods: 129 (85 catumaxomab; 44 control paracentesis) EpCAM-positive ovarian cancer patients with symptomatic malignant ascites were compared in an open-label, multicenter, randomized study for efficacy and tolerability of intraperitoneally given catumaxomab. Various in vivo and in vitro immunological and pharmacodynamic parameters were measured directly from ascites cell preparations. Results: During the course of catumaxomab treatment in the ascites fluid tumor cells dramatically decreased and leukocytes increased. Accordingly, the in vivo effector/target ratio (CD45+/EpCAM+) showed an drastic increase from a baseline of 6:1 to 10,000:1 already after the first infusion (all median). Leukocyte expansion was accompanied by in vivo upregulation of T cell activation marker CD69 on CD4+ and CD8+ T cells in the ascites fluid and an increase of IL-6 in serum at 24 hours after each infusion indicating systemic effects of catumaxomab. In vitro pharmacodynamic studies were carried out with screening samples to further validate the in vivo results. Similarly, the in vitro experiments showed efficient EpCAM+ tumor cell elimination, leukocyte expansion, drastical improvement of the effector/target ratio and activation of T cells. Additionally, a strong upregulation of activating cytokines IL-2 and IFN-γ (TH1 cytokine profile) and proliferation of CD4+, CD8+ T cells and CD11c+ accessory cells were demonstrated in the samples with catumaxomab compared to controls. Conclusions: Intraperitoneal catumaxomab treatment triggers activation and proliferation of different immune cells and leads to elimination of tumor cells within malignant ascites. These data confirm the postulated mode of action of trifunctional catumaxomab in vivo and correlate with clinical efficacy in patients with malignant ascites. [Table: see text]

Surgical Management of Metastatic Peritoneal or Pleural Disease

The surgeon's role in the treatment of malignant peritoneal disease has expanded over time, stemming from a better understanding of tumor biology. For the majority of patients, carcinomatosis is a terminal process with surgical intervention being reserved for palliation of bowel obstruction or symptomatic ascites. However, for select patients with favorable tumor biologies, aggressive surgical approaches may result in long-term survival. This review describes the patterns of peritoneal tumor dissemination, surgical palliation of malignant bowel obstruction or ascites, and the principles, indications, toxicities, and overall results of cytoreductive surgery with intraperitoneal hyperthermic chemotherapy. On the other hand, long-term survival is rarely expected for malignant pleural disease unless the causal tumor is highly responsive to systemic chemotherapy. There are controversies and considerable geographic variations in the management of malignant pleural effusions. However, less invasive ambulatory palliative treatments for patients so afflicted are gaining popularity.

Diagnosis of Pulmonary Embolism

Case 1: A 77-year-old Caucasian woman with a probable diagnosis of ovarian cancer developed an acute onset of shortness of breath two days after being discharged for a workup of symptomatic ascites. Her medical history was signifi cant for hypertension and atrial fi brillation, and she was taking therapeutic doses of coumadin. She presented to the emergency department; was found to have a large, left pleural effusion; and was admitted to the hospital. A thoracentesis removed 2.1 L of fl uid. The patient’s respiratory distress improved; however, she experienced a second episode of sudden onset shortness of breath prior to her anticipated discharge. She was afebrile, with a room air pulse oximetry of 80%, pulse of 121 beats per minute, and respiratory rate of 28. A chest x-ray (CXR) showed only a small pleural effusion remaining on the left. An electrocardiogram (EKG) showed atrial fi brillation. A chest computed tomography (CT) was performed and showed bilateral pulmonary emboli.

Inferior Vena Cava Stenting: A Safe and Effective Treatment for Intractable Ascites in Patients with Polycystic Liver Disease

We performed a retrospective study of seven patients with polycystic liver disease who underwent stenting of the inferior vena cava for intractable ascites. All patients had symptomatic ascites and inferior vena cava stenosis demonstrable by venography. The mean pressure gradient across the inferior vena cava stenosis before stenting was 14.5mm Hg (range 6–25 mm Hg) and significantly decreased to a mean pressure gradient of 2.8mm Hg (range 0–6 mm Hg, p = 0.008) after stenting. Two patients also had stenting of hepatic venous stenoses after unsuccessful inferior vena cava stenting. After a mean follow-up of 12.2 months (range 0.5–39.1 months), five of the seven patients have had maintained clinical improvement, defined as decreased symptoms, diuretic requirements, and frequency of paracentesis. Four patients have required no further intervention. The other patient was lost in follow-up. Patients with clinical improvement had an overall larger mean pressure gradient before stenting (19.2 vs. 9.8mm Hg) and a larger Δ pressure gradient (15.8 vs. 7.8mm Hg) compared to those in whom stenting was unsuccessful. These results suggest inferior vena cava stenting is safe and effective and should be considered as a first-line intervention in the treatment of medically intractable ascites in select patients with polycystic liver disease.

The Ability of Existing Questionnaires to Measure Symptom Change After Paracentesis for Symptomatic Ascites

Symptomatic malignant ascites is a problem for patients with advanced intra-abdominal malignancy. Although the goal of paracentesis, the most common therapeutic intervention, is symptom palliation, the best method of assessing symptom improvement is unknown. The aim of this study was to assess the ability of existing symptom and quality-of-life questionnaires to detect change in symptoms after paracentesis. Patients with symptomatic ascites completed four questionnaires before and 24 hours after paracentesis. These tests were Edmonton Symptom Assessment System-Ascites Modification (ESAS:AM), Memorial Symptom Assessment Scale-Short Form, European Organization for the Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30), and the EORTC Core Quality of Life Questionnaire, 26-item pancreatic cancer module (QLQ-PAN26). Sensitivity, validity, reliability, and responsiveness of the questionnaires were evaluated. Sixty-one patients completed the baseline and 44 the follow-up questionnaire. Most patients had ovarian (41%) or gastrointestinal cancer (25%); Eastern Cooperative Oncology Group performance status was 2 (26%) and 3 (49%). Patients reported major symptoms at baseline; symptom scores were highest for the clinically recognized symptoms of ascites. Most patients (78%) reported that their symptoms improved after paracentesis. All questionnaires showed strong sensitivity, validity, and reliability. Subscales that included the most distressing symptoms were most responsive; great improvement was seen in abdominal bloating (42% to 54%), anorexia (20% to 37%), dyspnea (33% to 43%), insomnia (29% to 31%), fatigue (14% to 17%), and mobility (25%). The amount of fluid removed (median, 3.5 L; range, .3% to 9.7 L) did not correlate with symptom improvement (r = .29, P = -.10). Paracentesis provides symptom relief that can be measured by existing questionnaires. For future clinical trials of symptomatic ascites, the QLQ-C30 and the ESAS:AM together, or the QLQ-C30 with the addition of the QLQ-PAN26 ascites and abdominal pain subscales could be used.

68-Year-Old Woman With Hepatitis C and Abnormal Kidney Function

A 68-year-old woman with a history of hepatitis C (contracted from a blood transfusion in 1974) complicated by cirrhosis and portal hypertension came to the Mayo Clinic in Rochester, Minn, for evaluation for possible liver transplantation. Her symptomatic ascites had been treated initially with furosemide and spironolactone, but this treatment regimen was limited because of an increase in her creatinine level. During evaluation, hypertension (an average blood pressure of 180/90 mm Hg on 6-hour ambulatory monitoring) and abnormal renal function were noted. She was referred to our institution for further evaluation of her blood pressure and abnormal urinalysis results.

Percutaneous Placement of Peritoneal Port-Catheter in Patients with Malignant Ascites

We report our experience with a radiologically placed peritoneal port-catheter in palliation of malignant ascites. Port-catheters were successfully placed under ultrasonographic and fluoroscopic guidance in seven patients (five women, two men) who had symptomatic malignant ascites. The long-term primary patency rate was 100%. The mean duration of catheter function was 148 days. Seven patients had a total of 1040 port-days. Two patients received intraperitoneal chemotherapy via the port-catheter. There were no procedure-related mortality and major complications. Minor complications such as ascitic fluid leakage from the peritoneal entry site, migration of the catheter tip to the right upper quadrant, and reversal of the port reservoir occurred in four patients. None of these complications affected the drainage and required port explantation. In patients with symptomatic malignant ascites, a peritoneal port-catheter can provide palliation and eliminate multiple hospital visits for repeated paracentesis with high patency and low complication rates.

Doxorubicin levels in the serum and ascites of patients with ovarian cancer

Aims To investigate the diffusion and accumulation of doxorubicin metabolites in the ascites of patients with ovarian cancer following intravenous injection, as a model for intraperitoneal accumulation of drugs. Methods The concentrations of doxorubicin and its metabolites [Doxorubicinol (Dox-ol), 7-deoxydoxorubicinolone (7d-Dox-ol-on) and 7-deoxydoxorubicinone (7d-Dox-on)] were measured using high-performance liquid chromatography in the serum and in the ascites of seven patients with recurrent ovarian carcinoma suffering from symptomatic ascites and treated with intravenous doxorubicin. Results Doxorubicin metabolites accumulated in the peritoneal cavity. The concentrations of the doxorubicin metabolites were initially higher in the serum compared to the ascitic fluid, but following several hours the doxorubicin metabolites became higher in the ascites, and remained detectable in the ascites for up to 168 h, long after disappearance from the serum. Conclusions Doxorubicin metabolites accumulate in the ascites and are cleared more slowly from the peritoneal compartment than from the serum. Accumulation in the peritoneal cavity with prolonged half-life should be considered when administering medication in patients with ascites.

Advances in critical care management of hepatic failure and insufficiency

Chronic liver disease is becoming an increasingly frequent diagnosis for patients in the intensive care setting with such diagnoses as symptomatic ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, or fulminant hepatic failure. To review frequent diagnoses for patients with chronic liver disease admitted to the intensive care unit and discuss current concepts in management and investigational modalities. Patients with new-onset ascites in the intensive care setting should undergo immediate ultrasound to rule out acute thrombosis. A transjugular intrahepatic portosystemic shunt is indicated when control of the refractory ascites or hepatic hydrothorax is required. In patients with hepatorenal syndrome, hemodialysis can be used as a bridge to liver transplantation. Otherwise, hepatorenal syndrome carries a high mortality. When hepatic encephalopathy is present, a precipitating cause should be sought and treated, if identified. Although bioartificial support systems are under active investigation, standard treatment for hepatic encephalopathy is lactulose and alteration of gut flora. Patients with fulminant hepatic failure should be stabilized and transferred to the intensive care unit of a liver transplant center and supported with appropriate airway management, close neurologic evaluation, glucose monitoring, and correction of coagulopathy when there is overt bleeding or an invasive procedure is planned. Intracranial pressure monitoring is recommended to maintain an adequate cerebral perfusion pressure of >60 mm Hg. Review of the literature demonstrates that certain critically ill patients with chronic liver disease may benefit from invasive modalities such as transjugular intrahepatic portosystemic shunting, hemodialysis, and in some cases, liver transplantation, which may be offered only at tertiary care centers.

The use of bevacizumab to palliate symptomatic ascites in patients with refractory ovarian carcinoma

Objective To evaluate our experience with the use of bevacizumab in patients with heavily pretreated recurrent ovarian carcinoma who have symptomatic ascites. Methods Four patients were identified who were previously heavily pretreated for recurrent ovarian carcinoma. Each had symptomatic ascites and required frequent therapeutic paracenteses. Each was treated with bevacizumab with the intent to palliate symptomatic ascites. Clinical data including demographic data and clinicopathologic variables was abstracted. Results The four patients demonstrated symptomatic relief of ascites. Toxicity was manageable in all patients with no grade 3/4 toxicity observed. In addition to symptomatic relief of ascites, no therapeutic paracenteses were required after initiation of therapy with bevacizumab. Conclusions Bevacizumab may be a viable palliative option in patients with end stage ovarian carcinoma who have symptomatic ascites.

A pilot study of a PANVAC-V and PANVAC-F in patients (pts) with metastatic carcinoma

2512 Background: The vast majority of carcinomas express either MUC-1 or CEA. Preclinical and clinical studies have demonstrated that induction of T-cell responses directed against CEA and MUC-1 can lead to anti-tumor activity without toxicity. Two novel vaccines have been developed: (a) PANVAC-V (V) a recombinant vaccinia virus containing CEA and MUC-1 with modified agonist epitopes and 3 costimulatory molecule transgenes, and (b) PANVAC-F (F) a similar recombinant fowlpox virus. Methods: This pilot study enrolled 25 pts with metastatic carcinoma who had progressive disease after chemotherapy. Pts received V priming followed by F boosts every 2 weeks × 3 then monthly with restaging scans every 2 months while on study. All vaccines were given with sargramostim at the vaccine site. The primary endpoint was safety. Class I and class II immune responses to CEA were analyzed. Class I responses were assayed by ELISPOT, intracellular cytokine, and tetramer binding; and class II responses were assayed by ELISA using CEA protein and class II peptides. Results: Treatment was well tolerated with 135 cycles given. Only one grade 3 toxicity (syncope during a flu-like illness) was possibly related to vaccine. Apart from injection site reactions, only 9 cycles (7%) were associated with transient grade 2 toxicity (generally flu-like syndromes). Class I and class II immunologic responses were demonstrated. A pt with metastatic breast cancer and 5 large liver metastasis had a 24% decrease in unidimensional measurement of disease for 6 months. A pt with metastatic gastric cancer had stable disease for 5 months. Furthermore, a pt with metastatic clear cell ovarian cancer s/p chemotherapy had complete disappearance of large volume, symptomatic ascites accompanied by marked improvement in the appearance of mesenteric stranding and a CA-125 reduction from 281 U/mL to continued sustained normal values (< 20 U/mL). Conclusions: This vaccine can be given safely and can generate therapy specific immunologic responses. In addition 1 pt with metastatic ovarian cancer had a dramatic clinical response. Based on this, we have initiated a pilot study specifically for ovarian cancer pts to gain more information on which to base a large clinical endpoint trial. No significant financial relationships to disclose.

Malignant ascites: Systematic review and guideline for treatment

A guideline on the management of symptomatic malignant ascites by abdominal paracentesis, diuretics and peritoneovenous shunting, based on a systematic review of the literature is presented. Thirty-two relevant studies were identified. None were randomized control trials, one was a non-randomized open controlled trial, five were cohort studies or prospective uncontrolled trials, 26 studies were non-analytic studies like case series. Although paracentesis, diuretics and shunting are commonly used procedures, the evidence is weak. Available data show good, although temporary effect of paracentesis on symptom relief. Fluid withdrawal speed and concurrent intravenous hydration is not sufficiently studied. Peritoneovenous shunts can control ascites in patients with malignant ascites, but have to be balanced by the potential risks of this procedure. The available data about diuretics in treatment of malignant ascites are controversial. The use of diuretics therefore should be considered in all patients, but has to be evaluated individually.

Change in symptoms after paracentesis for symptomatic malignant ascites

6071 Background: Symptomatic malignant ascites is a significant problem for palliative patients with intraabdominal malignancy. Paracentesis is the most common therapeutic option. Although the main goal of paracentesis is symptom palliation, the best method of assessing symptom improvement is not known. The aim of our study was to compare existing and validated symptom and quality of life (QOL) questionnaires to assess their ability to detect a clinical improvement in symptoms after paracentesis. Methods: Patients with malignant ascites were asked to complete 4 symptom and QOL questionnaires before and 24 hours after therapeutic paracentesis. These included the Edmonton Symptom Assessment System, the Memorial Symptom Assessment Scale-SF and the EORTC Core and Pancreatic Cancer Module. Demographic data was collected, and the patient’s opinions about the questionnaires and the procedure elicited. Change scores were calculated by subtracting the baseline subscale scores from the follow-up scores. Results: 61 patients completed the baseline questionnaire and 44 completed follow-up questionnaire. Patients predominantly had ovarian (41%) and gastrointestinal cancer (25%); their ECOG performance status was 2 (26%) and 3 (49%). There was no systematic difference between respondents and non-respondents. Baseline questionnaires revealed a significant amount of baseline symptoms, with the worst scores in the symptom domains. The mean amount of fluid removed was 3.5 L (range 0.3–9.7 L); there were no complications. All questionnaires showed strong sensitivity, validity and reliability when applied to this patient population. Most patients (78%) reported that their symptoms had improved as a result of the procedure. Significant improvement was demonstrated for subscales that included the most distressing symptoms, such as abdominal bloating, anorexia, dyspnea, insomnia, fatigue, as well as overall QOL. The amount of fluid removed did not correlate with symptom improvement. Conclusions: Paracentesis provides relief of symptoms for patients with malignant ascites. The existing symptom and quality of life questionnaires are valid and sensitive to change and could be suitable for clinical trials of new interventions for paracentesis. No significant financial relationships to disclose.

Peritoneovenous shunting is an effective treatment for intractable ascites

Aim and methods: A retrospective review was carried out of children undergoing peritoneovenous shunting for intractable ascites. Results: 11 children, aged 3 months to 12 years (median 31 months) underwent...

A phase II clinical trial with proteomic profiling of imatinib mesylate in patients with refractory or relapsed epithelial ovarian cancer (EOC)

9651 Background: PDGFR-β and c-kit expression have been described in EOC and imatinib is an inhibitor of both. A phase II clinical trial with proteomic signal pathway profiling is underway to elucidate both the clinical and biological activity of this new agent in EOC. Methods: Patients with relapsed or refractory EOC and no more than 4 prior regimens received imatinib at 400 mg bid; the starting dose was lowered to 600 mg daily due to toxicity. Patients were treated continuously in 28 day cycles and examined every 4 weeks, with imaging every 8 weeks. Tumors were biopsied prior to and after 4 weeks of treatment. Cytokine and growth factor concentrations were measured by ELISA in plasma and fluid samples. Results: Sixteen patients with a median of 4 prior regimens have been enrolled with 15 evaluable. Seven patients (47%) started treatment at 400 mg bid; 4 withdrew within 1 month. The remainder (9) started at 600 mg qd. Five patients (33%) without evidence of disease progression experienced unacceptable toxicities. Eleven patients (73%) experienced grade 3/4 toxicities. Fluid related toxicities included the following events: ascites 40% (6/15), pleural effusion 27% (4/15), and/or peripheral edema 13% (2/15). Non-fluid related grade 3 toxicities included nausea 27% (4/15), vomiting 20% (3/15), constipation, anorexia, hypoalbuminemia, anemia, and leucopenia (1 each); Median time on study was 63 days. Disease stabilization was observed for 4 and 5 months in 2 patients, respectively. Plasma VEGF and PDGF-AB increases were greater in patients who developed symptomatic ascites (p= 0.0012 and 0.04, respectively). Ascites reversed with cessation of imatinib. Profiling by tumor lysate arrays of proliferation, survival, and angiogenesis signaling pathways in tumor and stroma, and a potential mechanism for imatinib-related ascites accumulation will be presented. Conclusions: Imatinib has significant fluid related toxicity in patients with EOC precluding assessment of clear benefit. Based on this data there may be potential benefits from combination therapy with angiogenesis inhibitors. No significant financial relationships to disclose.

Confirmation of the Activity of the Interleukin-2 Fusion Toxin Denileukin Diftitox against Chemorefractory Chronic Lymphocytic Leukemia, including Cases with Chromosome 17p Deletions and without Detectable CD25 Expression

Confirmation of the Activity of the Interleukin-2 Fusion Toxin Denileukin Diftitox against Chemorefractory Chronic Lymphocytic Leukemia, including Cases with Chromosome 17p Deletions and without Detectable CD25 Expression

Performance standards for therapeutic abdominal paracentesis.

Large-volume paracentesis, the preferred treatment for patients with symptomatic tense ascites due to cirrhosis, has traditionally been performed by physicians as an inpatient procedure. Our objectives were to determine (1) whether large-volume paracentesis could be performed safely and effectively by gastrointestinal endoscopy assistants and as an outpatient procedure, (2) whether the risk of bleeding was associated with either thrombocytopenia or prolongation of the prothrombin time, and (3) the resources used for large-volume paracentesis. Gastrointestinal endoscopy assistants performed 1,100 large-volume paracenteses in 628 patients, 513 of whom had cirrhosis of the liver. The preprocedure mean international normalized ratio for prothrombin time was 1.7 +/- 0.46 (range, 0.9-8.7; interquartile range, 1.4-2.2), and the mean platelet count was 50.4 x 10(3)/microL, (range, 19 x 10(3)/microL - 341 x 10(3)/microL; interquartile range, 42-56 x 10(3)/microL). Performance of 3 to 7 supervised paracenteses was required before competence was achieved. There were no significant procedure-related complications, even in patients with marked thrombocytopenia or prolongation in the prothrombin time. The mean duration of large-volume paracentesis was 97 +/- 24 minutes, and the mean volume of ascitic fluid removed was 8.7 +/- 2.8 L. In conclusion, large-volume paracentesis can be performed safely as an outpatient procedure by trained gastrointestinal endoscopy assistants. Ten supervised paracenteses would be optimal for training the operators carrying out the procedure. The practice guideline of the American Association for the Study of Liver Diseases which states that routine correction of prolonged prothrombin time or thrombocytopenia is not required is appropriate when experienced personnel carry out paracentesis.

42 Phase I study for treatment of ovarian cancer patients with symptomatic ascites using the trifunctional bispecific antibody removab ® (anti-CD3 X anti-EpCAM)

42 Phase I study for treatment of ovarian cancer patients with symptomatic ascites using the trifunctional bispecific antibody removab ® (anti-CD3 X anti-EpCAM)