Clinical trial NCT04032600: Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics
Official title: Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Ascites
Ovarian Cancer
Hemodynamic Instability
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The ATLANTIS-study was designed to determine the safety of a full paracentesis in patients with malignant ascites due to ovarian cancer. The underlying hypothesis states, that full paracentesis does not impair safety, compared to fractioned paracentesis with clamping of the drain. Half of the patients will receive a full paracentesis, while the other half will receive fractioned paracentesis with clamping of the drain after 3 liters of ascites was evacuated. All patients receive extensive monitoring of hemodynamics and kidney function.

Detailed description: Background: Malignant ascites is common in ovarian cancer and often causes symptoms such as abdominal pressure and shortness of breath, resulting in an decreased quality of life for the patient. Paracentesis is a safe and easy method for symptom relief. But no guidelines exist on the management of ascites drainage in ovarian cancer. In many cases a partial paracentesis is performed, due to fear of hemodynamic instability or kidney failure, with partial drainage of the intraperitoneal fluid on the first day and subsequent drainage on the next day. As there is no study that reported a deteriorated health due to full paracentesis in ovarian cancer, the decision whether a partial or total paracentesis is performed depends entirely on the department or the physician.

Since a total paracentesis can be performed as an out-patient treatment, this approach is often preferred by the patient. Full paracentesis is also more efficient and cost-effective.

The objective of the ATLANTIS-study is to prove the safety of total paracentesis regarding hemodynamic changes and kidney failure.

Methods: ATLANTIS is a randomized, prospective, clinical study that aims to include 60 patients. Patients with histologically confirmed epithelial ovarian, fallopian tube and peritoneal cancer are randomized into two arms: Partial (3 Liter) and total paracentesis. Before, during and for two hours after the paracentesis, an advanced hemodynamic monitoring is performed to ensure the patients' safety. The monitoring includes mean arterial pressure and stroke volume. After the initial phase of extensive monitoring (2 hours), the blood pressure is measured for a period of 24 hours to evaluate not only short term, but also long-term hemodynamic changes. Before and 24 hours after the paracentesis, blood samples are analyzed to detect a potential acute kidney failure.

Eligibility criteria: Inclusion criteria:

* Histologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer
* Symptomatic (e.g. abdominal pressure, pain, shortness of breath) malignant ascites with clinical indication for paracentesis and sonographic estimate of \>3 liters
* Patient information and written informed consent

Exclusion criteria:

* Age \<18 years
* Missing written informed consent
* Lack of sufficient knowledge of german or english language
* No willingness to consent to the storage or distribution of anonymised disease-specific data inside the clinical trial
* Placement inside a state facility due to judicial order
* Employee status at Charite-University Medicine of Berlin
* Chronic kidney insufficiency defined as serum creatinin levels \>1,2 g/dl at time point of admission
* Active neurologic/psychiatric disorder at time point of admission
* Cardiac insufficiency defined as \>NYHA I at time point of admission
* Manifest ileus at time point of admission
* Manifest chronic arterial hypo- or hypertension, defined as chronic baseline systolic pressure of \<90 or \>140 mmHg and diastolic pressure of \<70 and \>90 mmHg
* Active infection
* Blood clotting disorder (congenital or acquired)
* Thrombocytopenia (platelets \<80 000/nl)
* Active participation in another clinical intervention trial at time point of admission
* Chronic atrial fibrillation on time point of admission
* Status post cardiac pacer implantation
* Liver cirrhosis
* Liver metastases

Primary outcomes:
measure: Change of stroke volume
timeFrame: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
measure: Change of mean arterial pressure
timeFrame: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Secondary outcomes:
measure: Incidence of side effects in the post-paracentesis interval
timeFrame: 24 hours after the finish of the paracentesis
measure: Incidence of symptoms in the post-paracentesis interval
timeFrame: 24 hours after the finish of the paracentesis
measure: Change of stroke volume in the post-paracentesis interval
timeFrame: 2 hours after the finish of the paracentesis
measure: Change of mean arterial pressure in the post-paracentesis interval
timeFrame: 2 hours after the finish of the paracentesis
measure: Change of laboratory values
timeFrame: Serial measurements: 2 hours prior to paracentesis, 24 hours after paracentesis
measure: Urine excretion
timeFrame: 24 hours after the finish of paracentesis
measure: Quality of life- pre and post paracentesis: EQ-5D questionnaire
timeFrame: 2 hours before paracentesis, 24 hours after paracentesis and 1 week after paracentesis
measure: Ascites related symptoms- pre and post paracentesis
timeFrame: 2 hs before paracentesis, 24-hours after paracentesis and 1 week after paracentesis
measure: Measurement of exact drainage volume
timeFrame: Within 1 hour after the finish of paracentesis
measure: VEGF (vascular endothelial growth factor) level
timeFrame: Within 1 hour after the finish of paracentesis
measure: Change of venous return and mean systemic filling pressure
timeFrame: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite-University Medicine of Berlin, Department of Gynecology-Campus Virchow Klinikum
Study officials:
affiliation: Charite-University Medicine of Berlin, Department of Gynecology
name: Klaus Pietzner, MD
role: PRINCIPAL_INVESTIGATOR
References: