Management of Symptomatic Post-operative Lymphocele

Study Overview
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Brief Summary
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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.

Official Title
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Management of Symptomatic Post-operative Lymphocele With an Patient-controlled, Vascular Catheter: A Validation Study

Conditions
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Lymphocele

Intervention / Treatment
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* Procedure: Drainage and sclerotherapy.
* Procedure: Drainage alone.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic lymphocele after abdominal lymphadenectomy for cancer, age > 18 years old, informed consent signed, Exclusion Criteria: asymptomatic lymphocele, apparent infection of the skin or subcutaneus tissue over the lymphocele (in the place of potential catheter insertion), significant coagulopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Drainage and sclerotherapy.<br>Patients with symptomatic lymphocele who are managed with percutaneous drainage and sclerotherapy. | Procedure: Drainage and sclerotherapy.<br>* Lymphocele percutaneous / transvaginal drainage with a use of a vascular catheter followed by sclerotherapy.<br>|
| Drainage alone.<br>Patients with symptomatic lymphocele who are managed with percutaneous drainage alone. | Procedure: Drainage alone.<br>* Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with successful lymphocele treatment. | 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successful catheter insertion into lymphocele lumen. |  | 1 day | 
| Number of adverse events concerned with catheter insertion. |  | 2 months | 
| Number of adverse events concerned with sclerotherapy. |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphocele, sclerotherapy, drainage, percutaneous