Clinical trial · Observational
Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.
Management of Symptomatic Malignant Ascites With an Patient-controlled, Vascular Catheter - a Validation Study.
NCT02724683CI-TRIAL-00064204unknownClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to determine whether drainage with the usage of a fine, patient-controlled vascular catheter inserted into abdominal cavity is a feasible, safe and effective method in the management of symptomatic malignant ascites. Complications' rate of the procedure and patients' quality of life, nutritional status and experience on the treatment are main endpoints.
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 |
|---|---|---|---|
| Malignant Ascites | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ascites drainage with vascular catheter. | Device | — | UNRESOLVED |
| Interview. | Behavioral | — | UNRESOLVED |
| Nutritional status | Other | — | UNRESOLVED |
| Quality of life. | Behavioral | — | UNRESOLVED |
| Quality of procedure. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Symptomatic ascites drainage with CVC.
- description
- Patients with malignant, symptomatic, refractory ascites. Ascites drainage with vascular catheter (CVC) inserted into abdominal cavity will be performed. Patients will be asked to complete interview, quality of life questionnaire, nutritional status assessment and quality of procedure survey.
- interventionNames
- Device: Ascites drainage with vascular catheter.
- Behavioral: Interview.
- Behavioral: Quality of life.
- Device: Quality of procedure.
- Other: Nutritional status
Primary outcomes (2)
- measure
- Number of participants with adverse events.
- timeFrame
- 2 weeks
- description
- Early and late adverse events of the catheter placement and later drainage to be recorded.
- measure
- Change in quality of life.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with symptomatic, refractory malignant ascites, * supportive care (professional or family members) available at patients' home, * informed signed consent of the patient. Exclusion Criteria: * ascites not of malignant origin, * asymptomatic ascites, * suspected or clinically apparent infection especially at the site of planned drainage placement, * significant coagulopathy, * very poor performance status (PS4), * patient not able to read and sign informed consent, * mucinous ascites.
References
Publications (6)
- BACKGROUNDHui D, Bruera E. Integrating palliative care into the trajectory of cancer care. Nat Rev Clin Oncol. 2016 Mar;13(3):159-71. doi: 10.1038/nrclinonc.2015.201. Epub 2015 Nov 24. PMID 26598947
- RESULTStephenson J, Gilbert J. The development of clinical guidelines on paracentesis for ascites related to malignancy. Palliat Med. 2002 May;16(3):213-8. doi: 10.1191/0269216302pm509oa. PMID 12046997
- RESULTBecker G, Galandi D, Blum HE. Malignant ascites: systematic review and guideline for treatment. Eur J Cancer. 2006 Mar;42(5):589-97. doi: 10.1016/j.ejca.2005.11.018. Epub 2006 Jan 24. PMID 16434188
- RESULTStukan M, Lesniewski-Kmak K, Wroblewska M, Dudziak M. Management of symptomatic ascites and post-operative lymphocysts with an easy-to-use, patient-controlled, vascular catheter. Gynecol Oncol. 2015 Mar;136(3):466-71. doi: 10.1016/j.ygyno.2014.11.073. Epub 2014 Nov 28. PMID 25434633
- RESULTda Silva Fink J, Daniel de Mello P, Daniel de Mello E. Subjective global assessment of nutritional status - A systematic review of the literature. Clin Nutr. 2015 Oct;34(5):785-92. doi: 10.1016/j.clnu.2014.12.014. Epub 2014 Dec 26. PMID 25596153
- RESULTStukan M. Drainage of malignant ascites: patient selection and perspectives. Cancer Manag Res. 2017 Apr 12;9:115-130. doi: 10.2147/CMAR.S100210. eCollection 2017. PMID 28442933