Preoperative Ascites Drainage Versus Standard Care for Patients With Advanced Ovarian Cancer
NCT ID: NCT02742428
Last Updated: 2017-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
40 participants
INTERVENTIONAL
2018-01-31
2020-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Ascites drainage before surgery.
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.
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.
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.
Observation.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* signed informed consent of the patient.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Gdynia Oncology Center
OTHER_GOV
Responsible Party
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Maciej Stukan, MD, PhD
Dr
Principal Investigators
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Maciej Stukan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Gdynia Oncology Center
Locations
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Gdynia Oncology Center
Gdynia, , Poland
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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GCO-2
Identifier Type: -
Identifier Source: org_study_id
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