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

Gdynia Oncology Center

Status: Suspended

Conditions: Malnutrition; Ovarian Epithelial Cancer; Ascites

Treatments: Procedure: Acute paracentesis.; Behavioral: Nutritional status.; Device: Systematic ascites evacuation; Behavioral: Quality of life.; Behavioral: Interview.

Study type: Interventional

Funder types: Other

Identifiers

NCT02742428

GCO-2

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with significant ascites and suspected ovarian cancer scheduled for upfront cytoreductive surgery, or diagnostic laparoscopy and neoadjuvant chemotherapy, and the surgery is planned to be performed in at least 7 days,
• signed informed consent of the patient.

Exclusion criteria

• ascites not of malignant origin,
• low volume ascites,
• other then primary ovarian malignancy suspected,
• suspected or clinically apparent infection especially at the site of planned drainage placement,
• no patient's consent.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Ascites drainage before surgery.

Experimental group

Description:

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.

Treatment:

Device: Systematic ascites evacuation

Behavioral: Quality of life.

Behavioral: Interview.

Behavioral: Nutritional status.

Observation.

Other group

Description:

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.

Treatment:

Procedure: Acute paracentesis.

Behavioral: Quality of life.

Behavioral: Interview.

Behavioral: Nutritional status.