Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-31

Study Completion Date

2023-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

4D Phase Contrast MR: Hypertrophy in Liver Cancer

NCT02618447

Liver Cancer Cancer of the Liver

TERMINATED NA

Role of PET/CT in Peritoneal Deposits Assessment

NCT06137417

Peritoneal Metastases

NOT_YET_RECRUITING

A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast

NCT00147238

Bladder Cancer Genitourinary Cancer Prostate Cancer

TERMINATED NA

Imaging of in Vivo Sigma-2 Receptor Expression With 18F-ISO-1 Positron Emission Tomography in Metastatic Breast Cancer

NCT03057743

METASTATIC BREAST CANCER

TERMINATED

Comparison of Contrast Agents in Liver MR for the Detection of Hepatic Metastases

NCT04973007

Oligometastatic Disease Liver Metastases Colorectal Cancer

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Refractory Malignant Ascites

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paracentesis

Intervention Type PROCEDURE

Tunneled Intraperitoneal Drain (IPD)

Intervention Type DEVICE

Peritoneal-Venous shunts (PVS)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No