Status:
COMPLETED
Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Malignant Ascites
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 n...
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. Parac...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2019
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04032600
Start Date
August 1 2017
End Date
September 9 2019
Last Update
December 8 2020
Active Locations (1)
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1
Charite-University Medicine of Berlin, Department of Gynecology-Campus Virchow Klinikum
Berlin, Germany, 13353