Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

170

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach

2 countries

2 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7.9 years study duration

Study Start

First participant enrolled

January 1, 2016

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2016

Completed

11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed

7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed

Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

7.6 years

First QC Date

March 20, 2016

Last Update Submit

February 22, 2023

Conditions

Malignant Ascites

Keywords

ascitesdrainagecathetersymptomsmanagementquality of lifemalignantcancer

Outcome Measures

Primary Outcomes (2)

Number of participants with adverse events.
Early and late adverse events of the catheter placement and later drainage to be recorded.
2 weeks
Change in quality of life.
Change in quality of life measured with standard questionnaire EORTC-C15-PAL before the procedure and 1-2 weeks later.
2 weeks

Secondary Outcomes (4)

Number of participants with drainage complication during cancer treatment vs observation.
1 month
Number of participants with successful catheter placement.
2 weeks
Patient's experience on the treatment.
2 weeks
Change in nutrition habits.
2 weeks

Other Outcomes (2)

Change in nutrition status among participants with prolonged ascites drainage.
1 month
Number of ambulatory visits or hospital admissions.
1 month

Study Arms (1)

Symptomatic ascites drainage with CVC.

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.

Device: Ascites drainage with vascular catheter.Behavioral: Interview.Behavioral: Quality of life.Device: Quality of procedure.Other: Nutritional status

Interventions

Ascites drainage with vascular catheter.DEVICE

In case of symptomatic malignant ascites, the procedure of vascular catheter insertion into abdominal cavity will be performed, followed by slow, systematic drainage, on patient's demand.