Malignant AscitesATLANTISNCT04032600
Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics
A study testing Paracentesis in people with Malignant Ascites and Ovarian Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Ascites, Ovarian Cancer, Hemodynamic Instability
- What is being tested?
- Paracentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2017to 9 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite-University Medicine of Berlin, Department of Gynecology-Campus Virchow Klinikum
Berlin, 13353
About this study
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.
Read the 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.
- Conditions
- Malignant Ascites, Ovarian Cancer, Hemodynamic Instability
- Being tested
- Paracentesis
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacentesisProcedure or surgery
Full versus partial paracentesis (3 liters)
| Study group | Role | What they receive |
|---|---|---|
| Full paracentesis | Other | All ascites is drained Receives: Procedure: Paracentesis |
| Fractioned paracentesis | Other | 3 Liters are drained, then the drain is clamped and the rest of the ascites is drained on the next day Receives: Procedure: Paracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of stroke volume
Stroke volume is measured by advanced hemodynamic monitoring
Measured: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Change of mean arterial pressure
Mean arterial pressure is measured by advanced hemodynamic monitoring
Measured: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Secondary outcomes (11)
Incidence of side effects in the post-paracentesis interval
Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)
Measured: 24 hours after the finish of the paracentesis
Incidence of symptoms in the post-paracentesis interval
Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)
Measured: 24 hours after the finish of the paracentesis
Change of stroke volume in the post-paracentesis interval
Stroke volume is measured by advanced hemodynamic monitoring
Measured: 2 hours after the finish of the paracentesis
Change of mean arterial pressure in the post-paracentesis interval
Mean arterial pressure is measured by advanced hemodynamic monitoring
Measured: 2 hours after the finish of the paracentesis
Change of laboratory values
Measurement in plasma (Blood count, creatinin, AST, ALT, urea, aldosterone, renin, sodium, potassium, albumin, C-reactive protein, leukocytes)
Measured: Serial measurements: 2 hours prior to paracentesis, 24 hours after paracentesis
Urine excretion
Urin volume
Measured: 24 hours after the finish of paracentesis
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)
Measured: 2 hours before paracentesis, 24 hours after paracentesis and 1 week after paracentesis
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)
Measured: 2 hs before paracentesis, 24-hours after paracentesis and 1 week after paracentesis
Measurement of exact drainage volume
Measurement of exact drainage volume in millilitre
Measured: Within 1 hour after the finish of paracentesis
VEGF (vascular endothelial growth factor) level
Measurement of the concentration of hormone vascular endothelial growth factor in ascites
Measured: Within 1 hour after the finish of paracentesis
Change of venous return and mean systemic filling pressure
Venous return and mean systemic filling pressure is measured by advanced hemodynamic monitoring
Measured: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start1 Aug 2017
- Primary completion9 Aug 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant AscitesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Klaus Pietzner, Charite University, Berlin, Germany
- Investigators
- Klaus Pietzner, MD, Principal investigator, Charite-University Medicine of Berlin, Department of Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032600
- Sponsor's protocol ID
- EA 1/224/16
- Acronym
- ATLANTIS
- Status last verified
- Jul 2019
- First submitted
- 11 Feb 2018
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics
- ClinicalTrials.gov ID
- NCT04032600
- Acronym / sponsor ID
- ATLANTIS / EA 1/224/16
- Conditions
- Malignant Ascites, Ovarian Cancer, Hemodynamic Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full paracentesis | Other | Procedure: ParacentesisAll ascites is drained |
| Fractioned paracentesis | Other | Procedure: Paracentesis3 Liters are drained, then the drain is clamped and the rest of the ascites is drained on the next day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacentesisFull versus partial paracentesis (3 liters) | Procedure or surgery | Fractioned paracentesis, Full paracentesis |
Primary outcome
Change of stroke volume
Time frame: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Stroke volume is measured by advanced hemodynamic monitoring
Change of mean arterial pressure
Time frame: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Mean arterial pressure is measured by advanced hemodynamic monitoring
11 secondary outcomes
Incidence of side effects in the post-paracentesis interval
Time frame: 24 hours after the finish of the paracentesis
Incidence of symptoms in the post-paracentesis interval
Time frame: 24 hours after the finish of the paracentesis
Change of stroke volume in the post-paracentesis interval
Time frame: 2 hours after the finish of the paracentesis
Change of mean arterial pressure in the post-paracentesis interval
Time frame: 2 hours after the finish of the paracentesis
Change of laboratory values
Time frame: Serial measurements: 2 hours prior to paracentesis, 24 hours after paracentesis
Urine excretion
Time frame: 24 hours after the finish of paracentesis
Quality of life- pre and post paracentesis: EQ-5D questionnaire
Time frame: 2 hours before paracentesis, 24 hours after paracentesis and 1 week after paracentesis
Ascites related symptoms- pre and post paracentesis
Time frame: 2 hs before paracentesis, 24-hours after paracentesis and 1 week after paracentesis
Measurement of exact drainage volume
Time frame: Within 1 hour after the finish of paracentesis
VEGF (vascular endothelial growth factor) level
Time frame: Within 1 hour after the finish of paracentesis
Change of venous return and mean systemic filling pressure
Time frame: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Pietzner, MD principal investigator
Charite-University Medicine of Berlin, Department of Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracentesis in people with Malignant Ascites and Ovarian Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of stroke volume (time frame: 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.