Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics

Ovarian Cancer Clinical Trial

— ATLANTIS  

Official title:

Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032600
• Other study ID #: EA 1/224/16
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: September 9, 2019

Study information

• Verified date: July 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 9, 2019
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Carcinoma, Ovarian Epithelial
• Hemodynamic Instability
• Malignant Ascites
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• Paracentesis
Full versus partial paracentesis (3 liters)

Locations

Country	Name	City	State
Germany	Charite-University Medicine of Berlin, Department of Gynecology-Campus Virchow Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of stroke volume	Stroke volume is measured by advanced hemodynamic monitoring	20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Primary	Change of mean arterial pressure	Mean arterial pressure is measured by advanced hemodynamic monitoring	20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Secondary	Incidence of side effects in the post-paracentesis interval	Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)	24 hours after the finish of the paracentesis
Secondary	Incidence of symptoms in the post-paracentesis interval	Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)	24 hours after the finish of the paracentesis
Secondary	Change of stroke volume in the post-paracentesis interval	Stroke volume is measured by advanced hemodynamic monitoring	2 hours after the finish of the paracentesis
Secondary	Change of mean arterial pressure in the post-paracentesis interval	Mean arterial pressure is measured by advanced hemodynamic monitoring	2 hours after the finish of the paracentesis
Secondary	Change of laboratory values	Measurement in plasma (Blood count, creatinin, AST, ALT, urea, aldosterone, renin, sodium, potassium, albumin, C-reactive protein, leukocytes)	Serial measurements: 2 hours prior to paracentesis, 24 hours after paracentesis
Secondary	Urine excretion	Urin volume	24 hours after the finish of paracentesis
Secondary	Quality of life- pre and post paracentesis: EQ-5D questionnaire	Measured with the EuroQuol-Group 5 Dimensions - Visual analog scale (EQ-5D VAS) questionnaire, the questionnaire directs to characterize the quality of life by mobility, activities, pain and fear and subjective scale between 1 (worst) and 100 (best)	2 hours before paracentesis, 24 hours after paracentesis and 1 week after paracentesis
Secondary	Ascites related symptoms- pre and post paracentesis	Measured with the and Functional Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI) questionnaire, the questionnaire directs to characterise the symptoms associated to ascites regarding 13 factors e.g. appetite, sleep, activities, symptoms, emotional distress by 0 to 4 points. The maximum score is 52 (best result: 13x4), 0 is the minimum score (worst result 13x0)	2 hs before paracentesis, 24-hours after paracentesis and 1 week after paracentesis
Secondary	Measurement of exact drainage volume	Measurement of exact drainage volume in millilitre	Within 1 hour after the finish of paracentesis
Secondary	VEGF (vascular endothelial growth factor) level	Measurement of the concentration of hormone vascular endothelial growth factor in ascites	Within 1 hour after the finish of paracentesis
Secondary	Change of venous return and mean systemic filling pressure	Venous return and mean systemic filling pressure is measured by advanced hemodynamic monitoring	20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes