Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Ascites

Quality of Life

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.

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.

Ascites drainage with vascular catheter.

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.

Interview.

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.

Quality of life.

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

Quality of procedure.

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.

Nutritional status

Maciej Stukan, MD

Ivana Nohova

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.

Patients with symptomatic, refractory malignant ascites (MA) will be eligible for the study. In case a cancer treatment is not effective against ascites, or no target, systemic treatment is possible patients will be eligible for percutaneous placement of a vascular catheter into abdominal cavity followed be drainage performed in a regular basis when required, at home or ambulatory. Adult patients with every malignant disease, female and male, and coexisting symptomatic MA can be recruited.

Clinical, quality of life (QOL) and quality of the procedure data will be collected. The study is planned to be a multiinstitutional. A template is provided to collect essential clinical data concerned with a patient, malignant disease, procedure performance and complications. QOL and patients' experience on the treatment is to be evaluated with formal questionnaires - EORTC C15-PAL and FACIT-TS-G - permission to use granted from EORTC and FACIT respectively. Additionally, a nutrition monitoring will be performed (if possible and feasible) in patients with MA and drainage.

Data will be saved in a computer, secured data base for calculations. A cohort of 150 patients is planned to be collected. Duration of the study will depend on how many institutions will participate, and how fast patients will be recruited.

Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

Management of Symptomatic Malignant Ascites With an Patient-controlled, Vascular Catheter - a Validation Study.

Risk of malnutrition and ability to feed normally to be assessed with Subjective Global Assessment (SGA) questionnaire among participants with prolonged (1-2 months) ascites drainage.

Number of ambulatory visits or hospital admissions to manage symptoms caused by ascites.

Early and late adverse events of the catheter placement and later drainage to be recorded.

Change in quality of life measured with standard questionnaire EORTC-C15-PAL before the procedure and 1-2 weeks later.

Assessment of possibilities to provide cancer treatment with active ascites drainage via catheter, by reporting number of participants with adverse events during chemotherapy or radiotherapy, whichever applies and comparison to observation (patients with palliative intent only, no active cancer treatment).

From all eligible participants a number of participants with successful catheter placement followed by effective drainage will be recorded.

Patient's experience on the treatment measured with standard questionnaire (FACIT-TS-G).

Changes in ability to feed assessed in a descriptive way with the Subjective Global Assessment (SGA) questionnaire.

Maciej Stukan, MD, PhD

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Malnutrition

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nutrition Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

A group of patients with (or suspected for) advanced ovarian cancer and significant ascites. An indwelling catheter insertion into abdominal cavity and slow, systematic ascites evacuation for 7 or more days before surgery (if it cannot be scheduled immediately) will be performed. Patients will undergo an interview, will be asked to fill in questionnaires concerning a quality of life and nutritional status. If available noninvasive bioimpedance analysis will be performed and 2ml of blood will be taken for serum prealbumin concentration evaluation. If possible 20ml of ascitic fluid will be taken for cytology examination.

A group of patients with (or suspected for) advanced ovarian cancer and significant ascites. A standard of care: observation or acute paracentesis (\>5000ml) will be performed while waiting for the surgery (if it cannot be scheduled immediately). Patients will undergo an interview, will be asked to fill in questionnaires concerning a quality of life and nutritional status. If available noninvasive bioimpedance analysis will be performed and 2ml of blood will be taken for serum prealbumin concentration evaluation. If possible 20ml of ascitic fluid will be taken for cytology examination.

Systematic ascites evacuation via indwelling catheter inserted into abdominal cavity, sutured to the skin. Drainage performed by the patient, on demand with day limit of 2000ml, in ambulatory settings.

Systematic ascites evacuation

Evacuation of a large (\>5000ml) volume of ascites via single abdominocentesis. Allowed in observational arm only, in case of acute symptoms concerned with ascites.

Acute paracentesis.

Interview according to provided chart in order to collect data concerning symptoms, co-morbidities.

Patients will be asked to fill in a quality of life questionnaire (EORTC-C15-PAL) before randomization and 7 days later.

Patients will be asked to fill in (together with a physician) a questionnaire to assess risk of malnutrition (SGA) before randomization and 7 days later.

Nutritional status.

Patients with significant ascites and advanced ovarian cancer (AOC), undergoing complex, cytoreductive surgery are at risk of malnutrition, poor quality of life and the risk of hypo- or hypervolemia in a perioperative period. All these factors may cause hemodynamic consequences during anesthesia and surgery, and elevate the risk of morbidity and mortality.

The objective of the study is to evaluate, whether slow ascites evacuation for a few days before the surgery for AOC, could 1) influence the hemodynamic consequences of ascites on systemic circulation in patients undergoing surgery, 2) improve patient's quality of life and 3) ability to feed correctly before treatment starts, and thus lower the risk of perioperative morbidity.

Eligible patients are those with significant ascites, diagnosed or suspected for AOC, who are scheduled for primary surgery (both upfront cytoreduction or laparoscopic evaluation before neoadjuvant chemotherapy), that cannot be performed within next 7 or more days, for any reason. Patients will be asked to fill in quality of life questionnaire (QLQ). Clinical data, a Subjective Global Assessment (SGA) will be recorded. Patients will be randomized to either intervention arm A - insertion of vascular catheter into abdominal cavity and slow, systematic, daily ascites evacuation, or to observation arm B - standard of care with just observation (acute large volume (\>5000ml) paracentesis allowed if needed). Patients in both groups will be encouraged to use oral nutritional support. Randomization will be open, 1:1, for every eligible, consecutive patient. After 7 days patients will be interviewed, asked to fill in QLQ, patient's experience on the treatment survey, a SGA will be recorded. During the first hour of the surgery hemodynamic data from anethetic charts will be recorded along with other clinical data concerning patient's characteristics, surgery details and 30-day postoperative follow-up. A template is provided.

The hypothesis of the study is that slow, systematic ascites evacuation few days before surgery for advanced ovarian cancer can facilitate hemodynamic control of systemic circulation of patients undergoing surgery, and improve patients' quality of life, feeding ability before treatment starts. Secondary we would expect lower risk of perioperative morbidity and mortality.

Preoperative Ascites Drainage Versus Standard Care for Patients With Advanced Ovarian Cancer

Preoperative Slow Ascites Drainage Versus Standard Care for Patients With Proven or Suspected Advanced Ovarian Cancer - a Hemodynamic Impact on Systemic Circulation, Patient's Nutritional Status and Quality of Life: a Randomized Trial.

Number of adverse events concerned with catheter insertion for ascites drainage.

Ascitis fluid collected for cytology examination. The accuracy of ascitic fluid cytology in diagnosing ovarian cancer.

Changes in body fluid balance measured with bioimpedance analysis tools and defined with ECF and ICF. Parameters will be recorded at randomization, before surgery, and during the 1st hour of the anesthesia.

Changes in nutritional status measured with bioimpedance analysis tools and defined with PA. Parameters will be recorded at randomisation and before the surgery.

Changes in nutritional status measured with prealbumin plasma concentration.

Changes (minimal and maximal) in median arterial pressure during 1st hour of anesthesia during cytoreductive surgery for advanced ovarian cancer - comparison of two groups: with and without preoperative ascites drainage. MAP calculation - MAP = \[(2 x diastolic)+systolic\] / 3.

Volume of intravenous fluids transfused during the 1st hour of cytoreductive surgery for advanced ovarian cancer - comparison of two groups: with and without preoperative ascites drainage.

Need for using vasoconstrictors during 1st hour of cytoreductive surgery for advanced ovarian cancer - comparison of two groups: with and without preoperative ascites drainage.

Changes in HR (minimal and maximal) during 1st hour of anesthesia during cytoreductive surgery for advanced ovarian cancer - comparison of two groups: with and without preoperative ascites drainage.

Evaluation of changes in feeding ability before the treatment starts, according to Subjective Global Assesment survey - comparison of two groups: with and without preoperative ascites drainage.

To note any changes in quality of life evaluated with standardized quality of life questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.	NCT02724683	Malignant Ascit...	Ascites drainag... Interview. Quality of life... Quality of proc... Nutritional sta...	18 Years -	Gdynia Oncology Center
Preoperative Ascites Drainage Versus Standard Care for Patients With Advanced Ovarian Cancer	NCT02742428	Ascites Ovarian Epithel... Malnutrition	Systematic asci... Acute paracente... Interview. Quality of life... Nutritional sta...	18 Years -	Gdynia Oncology Center

Spots Global Cancer Trial Database for interview.

Every month we try and update this database with for interview. cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for interview.

Every month we try and update this database with for interview. cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for interview. cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.