Management of Symptomatic Post-operative Lymphocele
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|ClinicalTrials.gov Identifier: NCT02800980|
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : April 5, 2019
Symptomatic lymphocele (LC) can be a complication after pelvic and para-aortic lymphadenectomy performed for treatment or staging purposes in the management of some cancers. Management procedures are: single or repeated puncture, prolonged drainage with drains or catheters, mostly followed by sclerotherapy, or surgery. A decision, which management option is most optimal, should be guided by two principles: first to control patient's symptoms, second to apply the least invasive but effective way to treat LC, taking into account that the patient has undergone major surgery recently, and often needs adjuvant treatment at the moment when symptomatic LC is diagnosed.
The aim of this study is to validate feasibility, safety and efficacy of a minimally invasive management of a symptomatic LC - drainage with the usage of vascular catheter followed by sclerotherapy, as well as to evaluate patient's experience on the treatment.
Patients with symptomatic LC are evaluated with ultrasound. Data about diameters, estimated volume of LC and other organs failure if appear is recorded. Management options are discussed with patient, and if the method with catheter insertion and drainage is chosen than the patient is eligible for the study. After vascular catheter insertion into LC and fluid evacuation, patient is followed with active drainage. Patients with drainage only are observed for a short period of time (up to 7 days), and if not efficient a sclerotherapy is considered. In case a patient does not agree to sclerotherapy, or there are contraindications, or it is doctor's decision that drainage alone is sufficient, than the prolonged drainage without sclerotherapy is the only procedure. The choice about the regimen used for sclerotherapy, it's volume, time intervals between repeated infusion depend on institution practice.
Data concerning feasibility, safety and efficacy are noted in designated templates. Patients' experience on the treatment is evaluated with formal questionnaire FACIT-TS-G.
The study is observational. Primary outcome measure is to establish efficacy of the method. Secondary outcome measures are safety and patient's experience on the treatment.
Investigators hope to establish step-by-step guidelines for optimal, minimally invasive management of symptomatic lymphocele.
|Condition or disease||Intervention/treatment|
|Lymphocele||Procedure: Drainage and sclerotherapy. Procedure: Drainage alone.|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Management of Symptomatic Post-operative Lymphocele With an Patient-controlled, Vascular Catheter: A Validation Study|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 2021|
Drainage and sclerotherapy.
Patients with symptomatic lymphocele who are managed with percutaneous drainage and sclerotherapy.
Procedure: Drainage and sclerotherapy.
Lymphocele percutaneous / transvaginal drainage with a use of a vascular catheter followed by sclerotherapy.
Patients with symptomatic lymphocele who are managed with percutaneous drainage alone.
Procedure: Drainage alone.
Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy).
- Number of patients with successful lymphocele treatment. [ Time Frame: 2 months ]Successful lymphocele treatment means complete resolution of lymphocele after minimally invasive procedures - percutaneous drainage with a vascular catheter followed by sclerotherapy or drainage alone. Opposite - non successful treatment defined when the patient is refered for a surgical management.
- Number of successful catheter insertion into lymphocele lumen. [ Time Frame: 1 day ]
- Number of adverse events concerned with catheter insertion. [ Time Frame: 2 months ]
- Number of adverse events concerned with sclerotherapy. [ Time Frame: 2 months ]
- Patient's experience on the treatment. [ Time Frame: 2 months. ]measured with a questionnaire FACIT-TS-G (Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General) available from http://www.facit.org/facitorg/questionnaires. Permission to use obtained.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800980
|Contact: Maciej Stukanfirstname.lastname@example.org|
|Principal Investigator:||Maciej Stukan||Gdynia Oncology Center|