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Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

NCT02724683 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2023-02-23

No results posted yet for this study

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.

Conditions

  • Malignant Ascites

Interventions

DEVICE

Ascites drainage with vascular catheter.

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.

BEHAVIORAL

Interview.

Interview with patients will be performed according to attached chart. The aim is to collect data concerning patient's symptoms, co-morbidity, and basic clinical data about the primary malignancy and treatment status.

BEHAVIORAL

Quality of life.

Quality of life questionnaire (QLQ). Patients will be asked to complete QLQ at two time points: 1. immediately before the procedure, 2. one or two weeks after the procedure.

DEVICE

Quality of procedure.

Patients will be asked to complete quality of procedure questionnaire at one time point: one or two weeks after the procedure.

OTHER

Nutritional status

Risk of malnutrition and ability to feed normally will be assessed with specific questionnaire at two time points: 1. immediately before the procedure, 2. one or two weeks after the procedure.

Sponsors & Collaborators

  • Maciej Stukan, MD, PhD

    lead OTHER_GOV

Principal Investigators

  • Maciej Stukan, MD · Gdynia Oncology Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2023-08-31
Completion
2023-12-31

Countries

  • Czechia
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02724683 on ClinicalTrials.gov