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

NCT02742428 | Suspended

• 1 other identifier: GCO-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ascites; Ovarian Epithelial Cancer; Malnutrition

Outcome Measures

Primary Outcomes (4)

• Changes in median arterial pressure (MAP) during anesthesia.

  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.

  1 hour

• Volume of intravenous fluids transfused.

  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.

  1 hour

• Number of participants who required vasoconstrictors.

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

  1 hour

• Changes in Heart Rate (HR).

  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.

  1 hour

Secondary Outcomes (2)

• Changes in feeding ability.

  7 days

• Changes in patients' quality of life.

  7 days

Other Outcomes (5)

• Number of adverse events concerned with indwelling catheter insertion.

  7 days

• Number of participants correctly diagnosed with ovarian cancer based on ascitic fluid cytology.

  1 day

• Changes in Extracellular Fluid (ECF) and Intracellular Fluid (ICF).

  7 days

Study Arms (2)

Ascites drainage before surgery.

EXPERIMENTAL

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.

Device: Systematic ascites evacuation; Behavioral: Interview.; Behavioral: Quality of life.; Behavioral: Nutritional status.

Observation.

OTHER

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.

Procedure: Acute paracentesis.; Behavioral: Interview.; Behavioral: Quality of life.; Behavioral: Nutritional status.

Interventions

Systematic ascites evacuation DEVICE

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.

Ascites drainage before surgery.

Acute paracentesis. PROCEDURE

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

Observation.

Interview. BEHAVIORAL

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

Ascites drainage before surgery.; Observation.

Quality of life. BEHAVIORAL

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

Ascites drainage before surgery.; Observation.

Nutritional status. BEHAVIORAL

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.

Ascites drainage before surgery.; Observation.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gdynia Oncology Center: lead

Study Sites (1)

Gdynia Oncology Center

Gdynia, 81-519, Poland

Location

Related Publications (4)

• Hunsicker O, Fotopoulou C, Pietzner K, Koch M, Krannich A, Sehouli J, Spies C, Feldheiser A. Hemodynamic Consequences of Malignant Ascites in Epithelial Ovarian Cancer Surgery*: A Prospective Substudy of a Randomized Controlled Trial. Medicine (Baltimore). 2015 Dec;94(49):e2108. doi: 10.1097/MD.0000000000002108.

  PMID: 26656336 BACKGROUND

• Feldheiser A, Braicu EI, Bonomo T, Walther A, Kaufner L, Pietzner K, Spies C, Sehouli J, Fotopoulou C. Impact of ascites on the perioperative course of patients with advanced ovarian cancer undergoing extensive cytoreduction: results of a study on 119 patients. Int J Gynecol Cancer. 2014 Mar;24(3):478-87. doi: 10.1097/IGC.0000000000000069.

  PMID: 24463641 BACKGROUND

• Stukan M, Lesniewski-Kmak K, Wroblewska M, Dudziak M. Management of symptomatic ascites and post-operative lymphocysts with an easy-to-use, patient-controlled, vascular catheter. Gynecol Oncol. 2015 Mar;136(3):466-71. doi: 10.1016/j.ygyno.2014.11.073. Epub 2014 Nov 28.

  PMID: 25434633 RESULT

• Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.

  PMID: 26603969 RESULT

MeSH Terms

Conditions

Ascites; Carcinoma, Ovarian Epithelial; Malnutrition

Interventions

Interviews as Topic; Quality of Life; Nutritional Status

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Health Status; Demography; Epidemiologic Measurements; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Population Characteristics

Study Officials

• Maciej Stukan, MD, PhD

  Gdynia Oncology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 19, 2016
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 2, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)