Clinical trial · Observational
Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Industry funding not received. No subjects enrolled.
Summary
Brief summary (as posted)
Malignant ascites leads to significant morbidity in patients with terminal cancer. Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of relief after paracentesis are detrimental to quality of life(QOL). Two devices are available as alternatives to paracentesis. The impact of either device on QOL has not fully been explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom relief using validated survey instruments is proposed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Malignant Ascites | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paracentesis | Procedure | — | UNRESOLVED |
| Peritoneal-Venous shunts (PVS) | Device | — | UNRESOLVED |
| Tunneled Intraperitoneal Drain (IPD) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of Adverse Events
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Refractory malignant ascites defined as ascites requiring more than one paracentesis to control patient symptoms despite medical therapy with diuretics and a. peritoneal fluid with cytology positive for malignant cells OR * Known malignancy with imaging findings of peritoneal carcinomatosis . * Eastern Cooperative Oncology Group (ECOG) performance score 3 * Age greater than or equal to 18 * Capable of giving informed consent Exclusion Criteria: * Life expectancy less than one month * Coagulopathy defined as international normalized ration (INR) \>2 which cannot be corrected with fresh frozen plasma * Platelet count \<50,000/microliter, which cannot be corrected with platelet transfusion * Active skin infections at sites where PVS would be inserted * Presence of infectious peritonitis or bacteremia * Neutropenia * American Heart Association Class D congestive heart failure (ie New York Heart Association Class IV) * Stage 5 CKD (ie GFR \< 15 mL/min) * Severe hypoalbuminemia defined as \< 2.2 g/dL * Loculated or hemorrhagic ascites * History of bleeding gastroesophageal varices * Inability to provide informed consent * Unable to participate in neuropsychological tests / questionnaires * Pregnant or nursing women * Anasarca
References
Publications (0)
Data not yet available