Clinical trial · Interventional
Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemodynamic Instability | — | UNRESOLVED | — |
| Malignant Ascites | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paracentesis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Full paracentesis
- description
- All ascites is drained
- interventionNames
- Procedure: Paracentesis
- type
- OTHER
- label
- Fractioned paracentesis
- description
- 3 Liters are drained, then the drain is clamped and the rest of the ascites is drained on the next day
- interventionNames
- Procedure: Paracentesis
Primary outcomes (2)
- measure
- Change of stroke volume
- timeFrame
- 20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available