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Management of Symptomatic Post-operative Lymphocele

NCT02800980 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-04-05

No results posted yet for this study

Summary

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.

Conditions

  • Lymphocele

Interventions

PROCEDURE

Drainage and sclerotherapy.

Lymphocele percutaneous / transvaginal drainage with a use of a vascular catheter followed by sclerotherapy.

PROCEDURE

Drainage alone.

Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy).

Sponsors & Collaborators

  • Maciej Stukan, MD, PhD

    lead OTHER_GOV

Principal Investigators

  • Maciej Stukan · Gdynia Oncology Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02800980 on ClinicalTrials.gov