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

Malnutrition Clinical Trial

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.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02742428
• Other study ID #: GCO-2
• Status: Suspended
• Phase: N/A
• First received: April 11, 2016
• Last updated: April 29, 2017
• Start date: January 2018
• Est. completion date: March 2020

Study information

• Verified date: April 2017
• Source: Gdynia Oncology Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: March 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ascites
• Malnutrition
• Neoplasms, Glandular and Epithelial
• Ovarian Epithelial Cancer
• Ovarian Neoplasms

Intervention

Device:
• Systematic ascites evacuation
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.

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

Behavioral:
• Interview.
Interview according to provided chart in order to collect data concerning symptoms, co-morbidities.
• Quality of life.
Patients will be asked to fill in a quality of life questionnaire (EORTC-C15-PAL) before randomization and 7 days later.
• Nutritional status.
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.

Locations

Country	Name	City	State
Poland	Gdynia Oncology Center	Gdynia

Sponsors (1)

Lead Sponsor	Collaborator
Gdynia Oncology Center

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View 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. — View 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®) So — View Citation

Stukan M, Lesniewski-Kmak K, Wróblewska 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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of adverse events concerned with indwelling catheter insertion.	Number of adverse events concerned with catheter insertion for ascites drainage.	7 days
Other	Number of participants correctly diagnosed with ovarian cancer based on ascitic fluid cytology.	Ascitis fluid collected for cytology examination. The accuracy of ascitic fluid cytology in diagnosing ovarian cancer.	1 day
Other	Changes in Extracellular Fluid (ECF) and Intracellular Fluid (ICF).	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.	7 days
Other	Changes in Phase Angle (PA).	Changes in nutritional status measured with bioimpedance analysis tools and defined with PA. Parameters will be recorded at randomisation and before the surgery.	7 days
Other	Changes in prealbumin concentration.	Changes in nutritional status measured with prealbumin plasma concentration.	7 days
Primary	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
Primary	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
Primary	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
Primary	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	Changes in feeding ability.	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.	7 days
Secondary	Changes in patients' quality of life.	To note any changes in quality of life evaluated with standardized quality of life questionnaire.	7 days