Clinical trial NCT02742428: Preoperative Ascites Drainage Versus Standard Care for Patients With Advanced Ovarian Cancer
Official title: 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.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Ascites
Ovarian Epithelial Cancer
Malnutrition
Lead sponsor: Gdynia Oncology Center
Sponsor class: OTHER_GOV
First posted: 2016-04-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in median arterial pressure (MAP) during anesthesia.
timeFrame: 1 hour
measure: Volume of intravenous fluids transfused.
timeFrame: 1 hour
measure: Number of participants who required vasoconstrictors.
timeFrame: 1 hour
measure: Changes in Heart Rate (HR).
timeFrame: 1 hour
Secondary outcomes:
measure: Changes in feeding ability.
timeFrame: 7 days
measure: Changes in patients' quality of life.
timeFrame: 7 days
Other outcomes:
measure: Number of adverse events concerned with indwelling catheter insertion.
timeFrame: 7 days
measure: Number of participants correctly diagnosed with ovarian cancer based on ascitic fluid cytology.
timeFrame: 1 day
measure: Changes in Extracellular Fluid (ECF) and Intracellular Fluid (ICF).
timeFrame: 7 days
measure: Changes in Phase Angle (PA).
timeFrame: 7 days
measure: Changes in prealbumin concentration.
timeFrame: 7 days
Locations:
city: Gdynia
country: Poland
facility: Gdynia Oncology Center
Study officials:
affiliation: Gdynia Oncology Center
name: Maciej Stukan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.